COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFCATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS

Substance name:	Diazene-1,2-dicarboxamide [C,C-azodi(formamide), ADCA]	
CAS number:	123-77-3	
EC number:	204-650-8	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Art. 57(f) (respiratory sensitiser)

Disclaimer: Comments provided during public consultation are made available in this document as submitted by the commenting parties. It was in the commenting parties own responsibility to ensure that their comments do not contain confidential information. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. RCOM has not been agreed by the Member State Committee nor has the document been modified as result of the MSC discussions. The table does not contain any confidential information.

Responses to comments

During the consultation of the Austrian Annex XV SVHC-Dossier for ADCA a considerable number of comments were made, mainly from industry. As the comments are very repetitive, the comments were grouped into a smaller number of principal arguments. In this box the responses to these major arguments are provided. In the comments table below it is referred to these responses.

Response #1 to the argument: No decision yet on the criteria to assess the equivalent level of concern of respiratory sensitizers.
The Competent Authorities of several Member States and the Commission/ECHA have been considering the possibilities and need for identifying substances with sensitising properties as SVHC under the ‘equivalent level of concern’ route set out in Article 57(f) of REACH. To support this work a number of criteria was developed by ECHA in cooperation with Member States authorities, which may be used in the assessment of substances with respect to their sensitising properties. These criteria include the severity, irreversibility and delay of health effects. Other criteria are the affected quality of life and societal concerns. Based on these factors and additional considerations used to compare the level of concern that exists between CMRs and sensitizers, it is possible to demonstrate that equivalent level of concern can exist and that certain sensitizers could meet the SVHC criteria under the equivalent level of concern route (Article 57(f)). The justification for an individual substance to be identified as an SVHC based on Article 57(f) requires a case by case consideration.
This assessment has been performed in the Annex XV dossier for ADCA at hand and it shows that ADCA fulfils the criteria of Art 57f. For ADCA there is scientific evidence that it is a respiratory sensitizer which induces occupational asthma. Exposure to ADCA may result in delayed onset of symptoms and persistent symptoms lasting for years resulting in serious social consequences and impairment of quality of life.
These conclusions have been supported by several of involved Member States.

Response #2 to the argument: It was a political decision not to include respiratory sensitizers in Article 57(f).
It was argued that in the discussion on REACH in the Council in 2005 a proposal to add respiratory sensitizers as an additional group of substances in Art 57 was finally not accepted in the Co-decision. However, it is noted that the legislator in Recital No 115 of REACH Regulation (EC) 1907/2006 established the general target that the available resources should be focused on substances of the highest concern. Apart from carcinogenic effects, mutagenic effects or effects toxic for reproduction the legislator also considers respiratory sensitisation as effect of highest concern. 

Response #3 to the argument: Only sensitizers of Cat 1A should be considered for authorisation.
It is correct that CLP regulation introduces (as from December 2012) the frequency of occurrence as a possible criterion for sub-classification. However, the boundary between these categories is not quantified neither it is clear as to whether the distinction between the subcategories should be made on the basis of potency (as an inherent property). For potency of ADCA no data are available up to now, therefore a decision between 1A and 1B for ADCA on the basis of potency is not possible. So far no classification proposal for respiratory sensitisation has been discussed in the Risk Assessment Committee and no experience is available for the application of the sub-categories for respiratory sensitizers.

Response #4 to the argument: The studies that have been used for the assessment of the equivalent level of concern are more than twenty years old.
The Annex XV dossier addresses the inherent properties of the substance ADCA based on available human data. The studies demonstrate the sensitising property of ADCA. This fact is independent from the exposure situation in Europe which has changed significantly during the last 20 years. The referred studies have been evaluated and judged to be of sufficient quality to conclude on the respiratory sensitising property of ADCA by the EC working group on classification and labelling, by OECD (CICAD 16) and by HSE UK for the purpose of deriving a national maximum exposure limit value. In addition, there are more recent cases within as well as outside Europe (national records from UK and NL; Kim, 2004) demonstrating the occurrence of asthma after exposure to ADCA. The available studies include also information on exposure levels resulting in respiratory effects. 
An additional argument raised by industry was the claim that the presented data from national records on occupational respiratory diseases (UK and NL) was not representative. It is noted that we have asked all Competent Authorities from Member States for respective information on occupational diseases caused by ADCA. Most Member States have not provided the requested information. In the dossier all information which has been provided by Member States was used and documented.

Response #5 to the argument: ADCA is often not used as powder anymore but in form of liquid paste dispersions or other polymer bound master batches hindering the formation of inhalable dust.
According to information from registration and various comments from the internet consultation ADCA in powder form is still on the market and in use (in addition to granulates and pastes) as documented by several comments made by industry in the public consultation. The measurements against exposure to humans range over wide spectrum from personal protection to closed automatic systems. Therefore, this type of exposure needs to be considered for further measures as well. Risk management measures in place will be considered in the decision making during the individual authorization process.

Response #6 to the argument: There is no risk associated with the handling of ADCA taking current risk management measures into account. 
We are grateful for information on the present situation in several companies (supported by documented safety measures, measured exposure data, surveys among a number of concerned downstream users, as well as evidence from individual reporting companies that asthma cases have not occurred). In the Annex XV dossier all information from registration including an additional questionnaire to registrants (from March 2012) as well as all public available data was considered. It is further noted that in accordance with REACH Article 59 (3) the key question in the present step of the procedure under REACH Title VII is the identification of a substance as SVHC on the basis of its intrinsic properties. Hence, arguments about the control of exposure and risks are not relevant for the decision to be taken now. It is very welcome that from the information provided about exposure control measures it appears that there are appropriate risk management measures in place in several companies. This together with the fact that production of ADCA has shifted to non-European location may explain the significant decrease of asthma cases in Europe during the last years. Company specific information on exposure and risk will be considered during the individual authorisation process.
In general information on uses, exposure, release and alternatives will be forwarded for discussion at later stages of the authorization process (prioritization, possible exemptions if applicable) in case the substance is identified as SVHC.
We consider it as an obligation for the registrants who provided additional information relevant to the registration to update their registration dossiers where necessary.

Response #7 to the argument: There is no potential for consumer exposure.
The present Annex XV dossier includes all available information on consumer use. The potential exposure of consumers to ADCA was concluded on the basis of registered uses (air fresheners, construction chemicals) and indication based on the SPIN database. Furthermore, measurements of residues of ADCA in articles show that the substance which should theoretically fully decompose during the production process is still present in articles in relatively low concentrations. However, as it is presently not possible to derive a threshold for the respiratory sensitisation effects, low doses may pose a risk to consumers. Moreover, sensitisation of the respiratory tract can result from dermal contact with a chemical respiratory allergen. The fact that ADCA is embedded in a polymer matrix does not guarantee zero exposure, as exposure may occur e.g. through abraded particles.    

Response #8 to the argument: Lack of suitable alternatives.
The detailed information on the problems concerning alternatives to ADCA is appreciated. It is evident that special sophisticated knowledge on the technical process using ADCA and other foaming agents can only be with the companies concerned.
According to the REACH Regulation it is not required to perform an evaluation of less hazardous and technically viable alternatives for the Annex XV Dossier.  Possible alternatives and their suitability are foreseen to be examined in the authorisation process by the applicant, who has a better technical understanding and knowledge of single processes and products. Based on the discussion there, authorisation will be permitted for a period of time for cases where appropriate alternatives are missing. This should enable industry to finally develop alternative techniques or to find alternative substances to substitute ADCA.
It should be mentioned, that it is no prerequisite for the inclusion of a substance in the candidate list that well-established alternative substances and technologies are already in place. In fact, Title VII of REACH is particularly designed for cases where there is currently no alternative for certain uses available. Industry should be motivated to continue the search for suitable alternatives.

Response #9 to the argument: Socio economic impacts of authorization.
Socio-Economic-Aspects are not to be considered at this stage of the process but at a later step during individual authorization applications by industry. For example, it was argued that ADCA in the plastic pipe industry has led to the development of a complete PVC recycling in Europe. Another example was the argument that environmental benefits via the production of insulation materials would help to save the consumption of raw materials, energy and oil. However, these arguments do not relate to the intrinsic property of ADCA as such, and, therefore should be considered at a later step of the decision.
In the comments of some industries it was argued that the listing of ADCA on the candidate list would lead to significant damaging economic effects for industry. However, it should be emphasised that the objective of setting a substance on the candidate list is to identify it as an SVHC substance (with consequences such as information requirements acc. to Art. 7 and 33 of REACH) rather than to introduce any market barrier. 

References
Kim C., Cho J., Leem J., Ruy J., Lee H., Hong Y. Occupational asthma due to azodicarbonamide. Yonsei Medical Journal 45, No 2, 325-329, 2004.	

PART I: Comments and responses to comments on the SVHC proposal and its justification

General comments on the SVHC proposal
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
71	2012/10/18	Company
GERFLOR
France
	GERFLOR thinks that 
the risks from ADCA use have been adequately addressed, the solutions to replace it are not proved to be better, the impacts on customers health are minimum. 

So, GERFLOR doesn’t agree the Austrian proposal to list ADCA as a SVHC substance and to include it on the REACH candidate list for authorization, and hopes that the Austrian proposal should be retracted.	See responses #5, 6,7,8

			See also:
Comment 71 attachment (1210 GERFLOR ADCA ECHA.doc).doc		
70	2012/10/18	Industry or trade association
European Plastics Converters (EuPC)
Belgium	Adequate risk management measures are recommended by ADCA manufacturers through their safety data sheets and our survey confirms those are put into place in order to ensure workers protection. There has been no evidence of cases of asthma reported across industry. This means that the current classification of ADCA already triggers the implementation of the necessary exposure controls. 

Not only, the need for listing of ADCA as a substance of very high concern is only weakly substantiated in the annex XV dossier but also it does not seem that it would have any added health benefit since it seems that risk is today adequately controlled. 
Triggering a substitution move would not only create a huge economic damage across the whole plastics industry, it could also prove technically unfeasible and this for unproven alternatives.  ADCA being a major blowing agent used across industry, it is questionable whether appropriate alternatives would anyhow be available in sufficient quantities in the near future. 	Thank you for the information on the survey conducted by your association. To the argument that the current classification of ADCA together with the RM measures taken by the companies in the survey would be sufficient to control the health risks, see responses #5, 6,8,9. An authorisation would ensure that all companies within Europe would apply the same level of RM measures.	
			CONFIDENTIAL attachment removed		
69	2012/10/18	Industry or trade association
Wirtschaftsverband der deutschen Kautschukindustrie e. V. (wdk)
Germany	wdk is the German trade association representing about 85% of national rubber manufacturing industry. Member companies employ 75.000 workers and the aggregated turnover (2011) is at 12 Billion Euro. This is roughly 25% of European rubber industry, the biggest share at EU level. 
With the exception of tyre producers the rubber sector is SME structured. For further information please consult http://www.wdk.de/en/index.html or contact our office. 

C,C’-azodi(formamide) – ADCA – EC no. 204-650-8 , CAS no 123-77-3 is used in rubber industry for very specific and limited applications. The substance has the function of a blowing agent. The articles where ACDA may be introduced are shock absorbing mats / blocks and sealings. The sealings are most commonly used in automotive industry. 

The purpose of the dossier is to give evidence of ACDA having the hazard properties equivalent to 1907/2006EC Art. 57a-e properties classifying a substance as of very high concern. However as far as the use in rubber industry is concerned, the recognised sensitising potential of ADCA is not at a risk level compared to a SVHC. This is the overall experience covering the previous two decades of use.

The introducing statement in the dossier (P.9) and the conclusion (P.22) of a “… potentially exposure of consumers is likely to occur under normal conditions of use” is not justified and there is no scientific evidence at all. Even in case of remaining unreacted traces of ADCA in rubber sealings the substance is bound in the polymer matrix immobile for inhalation. Measurements of finished articles confirmed a very low ADCA concentration from below detection limit up to < 0,1 % w/w. 	See responses #6, 7	
66	2012/10/18	Other contributor
ADCA Task Force
Belgium	18 October 2012

Comments on the proposal of Austria for identification of C,C’-azodi(formamide) (ADCA) as Substance of Very High Concern

These comments are prepared by a coalition including the main companies producing and importing ADCA. Over 50 downstream users of ADCA in Europe have provided specific information on workers protection measures in place, exposure and substitution. 
In summary, ADCA is a respiratory sensitizer, for which the Annex XV dossier failed to demonstrate its equivalent concern to a CMR. The risk management measures including use of closed systems and Personal Protective Equipment implemented by industry in recent years has resulted in dramatic fall to almost zero in the number of workers developing asthma. ADCA has been used by several important industry sectors in Europe. It is used in high temperature industrial conditions above 100 ºC which excludes any consumer uses. ADCA is contributing substantially to energy saving, reduction of fuel use and CO2 emission and raw material saving which helps achieving the EU ambitious targets of resource and energy efficiency. As suitable alternatives do not exist, prioritising ADCA would constitute further safety and environmental step back, effecting hundreds of workers and thousands of employees in the EU. 

About ADCA
•	Uses and market
ADCA is a foaming/forming agent which has been registered for industrial uses only. Consumer uses are not covered by the lead registrant’s dossier.
It is used by main downstream user sectors, important for the EU economy, such as automotive (sealing, moss and sponge rubber, corrosion protection, artificial leather), construction (cold/hot water pipes, heating pipes, sewage pipes, decking, siding, signal sheets, thermal insulation, vinyl covering), electrical application (cables), shoe soles (standard and medical), sport and leisure products (gymnastic mats, canoes, physiotherapeutic products).
ADCA is used to expand the polymer matrix; it decomposes in the final processing step in an industrial environment. Therefore, finished articles may contain only small traces of ADCA embedded in the polymeric matrix and not available for inhalation. In case of presence, the concentration of such traces is usually below or around 0.1%.
ADCA is not produced anymore in Europe and it is mostly imported from Japan, China, Indonesia, India, and Korea. The quantities have increased significantly over the past years.

•	Benefits to the environment 
The substance is used by the European industry to save raw material, reduce energy and resources, thus contributing to EU targets regarding the efficient use of energy, mineral oil, fuel and CO2 emission reduction. 
Foaming with ADCA can contribute to raw material savings of over 65% (e.g. in rigid PVC foam sheets, sewage pipes) or even over 90% (e.g. in thermal insulation, automotive trim). This results in reducing substantially the weight of the finished goods, which has a very positive impact such as reduction of fuel consumption and consequently of reduction of CO2 emissions (automotive sector). In addition, weight reduction contributes substantially to the reduction of fuel and energy consumption during the transportation of the products and their entire lifetime.
ADCA use as blowing agent to expand insulation material in construction contributes tremendously to the energy efficiency of the buildings. In addition to this, considerable energy savings are achieved through optimal insulation of air-conditioning and refrigeration systems.

Comments on the Annex XV dossier
•	ADCA is not of equivalent concern to a CMR
C,C’-azodi(formamide) (ADCA) is classified as a respiratory sensitizer, however this does not make it automatically eligible for SVHC identification. Because of the legislator’s specific will not to include respiratory sensitisers as a category qualifying for SVHC, there should be evidence of effects more serious than those inherent to all respiratory sensitisers, such as severity of the effects, irreversibility, no safe concentration and delay of health effects.
The ROI proposal does not demonstrate that ADCA is of equivalent concern to a CMR. The potential adverse health effects considered in the dossier relate to its sensitising properties, for which ADCA is currently classified as respiratory sensitiser cat.1. 
All the reported health effects are nothing more than those typically caused by the category of respiratory sensitisers and have nothing specific to ADCA. In this regard, we note, however, that the supporting data are old and in contrast with new monitoring data which shows a dramatic drop to essentially zero in the cases of suspected but not proven ADCA-related adverse effects among workers and severity of these effects, as well as new scientific data on potency. 
Given that ADCA has a low to moderate frequency of occurrence of respiratory sensitisation in humans and no apparent potency in animals the weight of evidence indicates that ADCA can be assigned to Sub-category 1B for Respiratory Sensitisers according to the EU Classification, Labelling and Packaging of substances and mixtures (CLP). 
As with the severity of the effects, also other factors like irreversibility, the difficulty to determine safe concentration and the delay of the health are common to all respiratory sensitisers. 

•	Risk management measures in place
Data show that the risks from the above effects can be and are now adequately addressed as a result of a combination of worker protection legislation and complementary risk management measures, including use of closed systems, Personal Protective Equipment, identified and implemented by industry in recent years and now obligatory as part of the REACH obligations, including registration. 
Little notice appears to be taken of the dramatic fall to almost zero in the number of workers developing asthma with a suspected potential link to ADCA. This fall is in large part due to better training and provision, the use of closed systems including local exhaust ventilation, and use of protective equipment, such as dust masks, protective gloves, local exhaust ventilation, aspiration systems and dust filters, overall protecting clothing; with the cessation of manufacturing in Europe also playing a key role. Austrian proposals for improvements to Personal Protection Equipment do not appear to be addressing the current situation in Europe.

Threshold values for ADCA are established and working well under other regulations (e.g. the Maximum Exposure Level introduced in the UK in 1996). 
It follows from the foregoing that there is no support for the Austrian claim that ADCA is of equivalent concern to a CMR.

•	Lack of suitable alternatives
Potential alternatives, such as OBSH, TSH, TSSC, 5PT, DNPT, Sodium Bicarbonate/Modified Sodium Bicarbonates, Isopentane, Isobutane and CO2, Inflammable physical blowing agents, Halogenated products, have been tested for substitution of ADCA. However, due to unique properties and blending methods those either do not work or result in far inferior product quality of foamed products. In the case of insulation materials (cold/hot water and heating pipes), alternative blowing agents would lead to a higher material density. This would result in a significantly higher thermal conductivity. The insulating material would be less efficient, which could only be compensated by using significantly more material (thicker insulation), resulting in additional environmental impact (transportation, disposal etc.). Also processing / production would consume more space (bigger factories, higher prices for the consumer).
Another example is the hazard classification of the theoretically suitable alternatives (e.g . for OBSH and TSH – Flam. Sol. 2, Self-react. CD (Heating may cause a fire), Acute Tox. 4 , Skin Irrit. 2, Eye Irrit. 2, STOT SE 3 (May cause respiratory irritation)) that would discourage customers from using products in pharmaceutical, medical or orthopedical applications. Furthermore, some alternatives are explosive and more dangerous to handle.
Another common feature of the alternatives is that their commercial availability is much lower compared to ADCA.
Therefore, a substitution of ADCA would constitute further safety and environmental steps back.	

We thank you for the information from the downstream user survey. 

We took note of the comment that the registered consumer uses are not supported by the lead registrant and are considered as “possible errors”. They are therefore not covered by the CSR. However, the Annex XV dossier should include all available information on uses. As long as the registration is not corrected, we have to rely on the registrants’ information. 
See also response #7.

In the provided ADCA fact sheet it is stated that ADCA would contribute to up to 90% raw material savings and weight reduction would lead to significant energy savings (automobile sector). However, the consideration of such effects is part of the socio-economic consideration which is dealt with in the individual authorisation procedure. See also response #9.

We are neither aware nor did we receive any new data on potency of ADCA.
See also responses #1 to 4. 

On ETUC List (comment in fact sheet): We agree that the allocation of 10 points in the IARC column seems to be a mistake in the ETUC-list; however it did not influence our decision to select ADCA as a candidate substance for authorization.

We took note of the fact that the downstream user survey did only indicate one occupational asthma case the origin of which is not clear. This underlines your argument that presently adequate RMMs seem to be applied in the surveyed companies. However see responses #5 and 6. 

According to REACH guidance R.8 currently available methods and data do not allow the determination of a threshold and establishment of a DNEL for respiratory sensitisation. The DNEL derived in the CSR is based on systemic effects and does not cover the sensitizing property of ADCA.
As the criteria for an occupational exposure standard have not been met UK established a Maximum exposure level (MEL) for ADCA, (which is no health based threshold level but based on technical practicability for industry). The effectiveness of this MEL cannot be evaluated as in the same decade the production in UK stopped and this seemed to be the main contributor to reduced asthma cases.

We appreciate the additional information on alternatives and took note of the argument that at present the listed alternatives are either less efficient or possibly more hazardous. However, see response #8.

See also responses to comment number 43 of part I - Specific	
			See also:
Comment 66 attachment (Consolidated comments + ADCA Fact Sheet.zip).zip
CONFIDENTIAL attachment removed		
64	2012/10/18	Company
GRANDECO Wallfashion Group succursale France
France	None	See responses # 5, 6	
			See also:
Comment 64 attachment (ADCA Wallco Industry Statements.pdf).pdf		
63	2012/10/18	International NGO
Health and Environment Alliance
Belgium	We support the nomination and adoption of this chemical to the candidate list.	Thank you for your support. 	
62	2012/10/18	Industry or trade association
GIFAS
France	PLEASE REFER TO ATTACHED DOCUMENT	See response # 6

Thank you for the information that for your applications of ADCA alternative solutions could be validated soon.	
			See also:
Comment 62 attachment (20017_2012_Echa_54 SVHC consultation.pdf).pdf		
59	2012/10/18	Company
S.C TROPAL ROMANIA S.R.L
Romania	It is not secret that Tropal, as part of Palziv Group,are against this proposal. It is ludicrous to even consider ADCA in the same category as Carcinogens, Mutanogens and Reproductive Toxicants and the flimsy evidence brought by the Austrian Environment Agency can easily be picked apart by a competent legal authority. The banning of ADCA would ultimately signal the closure of Tropal in Romania because neither technically nor financially, could a replacement blowing agent be use. Rather than suggesting constructive and useful improvements to worker safety, it seems that the "easy way out" for the Agency is to stop the use completely, and ignore the consequences (unemployment, loss of export, loss of Tax revenues in the country, etc).	See responses #6,8 and 9	
			CONFIDENTIAL attachment removed		
58	2012/10/18	Company
Trelleborg Industri AB
Sweden	There is no indication of an increased illness level in our manufacturing process. On our shop floor, ADCA is handled for decades under safety precautions like local exhaust ventilations and personal protective equipment (e.g. gloves and dusk masks). We do not observe any increased illness rates, especially not on asthma cases in relevant work places where ADCA is processed. 
Evaluation of the ADCA exposure in our plants and from the final     products:	See response #6	
56	2012/10/18	Company
The Palziv Group
Israel	The Palziv group,which is based in Israel, but that has manufacturing facilities in Romania  (Tropal), Canada (PXL) and the USA (Palziv North America)  are against this proposal. It is ludicrous to even consider ADCA in the same category as Carcinogens, Mutanogens and Reproductive Toxicants and the flimsy evidence brought by the Austrian Environment Agency can easily be picked apart by a competent legal authority. 
The banning of ADCA in the EU would ultimately signal the closure of Tropal in Romania because neither technically nor financially, could a replacement blowing agent be used. Rather than suggesting constructive and useful improvements to worker safety, it seems that the “easy way out” for the Agency is to stop the use completely, and ignore the consequences (unemployment, loss of export, loss of Tax revenues in the country etc.). 	Repetition of comment #59	
			Confidential attachment submitted		
52	2012/10/18	Member State
Norway	The Norwegian CA supports that C, C'-azodi(formamide) (ADCA)fulfill the criteria of article 57 f) since evidence exists of serious effects to humans which give rise to equivalent level of concern as CMR substances. ADCA is harmonized classified as a strong respiratory sensitizer (Resp. Sens. 1) in the CLP regulation and no "safe" no effect level can be derived as regards to the induction of sensitization. During the elicitation phase, the substance may evoke chronic inflammation of the lungs and this can lead to serious and permanent impairment of the lungs. The induced sensitization is irreversible, and exposure of the substance may result in a considerable increased risk of elicitation of respiratory sensitization of affected persons. This may cause limitations of normal working life and could require long term medication. We support that the criteria of article 57 f) is fulfilled and that this substance is of equivalent level of concern as CMR (Cat. 1 or 2) substances. ADCA should be identified as a SVHC substance.	Thank you for your support. 	
51	2012/10/18	Company
VOWALON Beschichtung GmbH
Germany	Wir als Hersteller von Kunstleder verwenden bereits seit vielen Jahren Azodicarbonamid als Treibmittel in PVC-Beschichtungen. Zum Schutz der Mitarbeiter werden Vollmasken mit dem Staubfilter P2, chemikalienbeständige Handschuhe und Arbeitschutzvollanzüge verwendet. Für den Mischereibereich sind durch die bestellte Fachkraft für Arbeitssicherheit Gefährdungsanalysen und die daraus resultierenden Gefährdungsbeurteilungen erstellt. Alle Arbeitsschritte wurden überprüft, um mögliche Gefährdungspotentiale aufzuzeigen. Resultierend erfolgen Maßnahmen zur Umsetzung. Kürzlich wurde die Staubbelastung bei der Verwendung von Azodicarbonamid durch ein externes, zertifiziertes Ingenieurbüro überprüft. Die Messung ergab  0,19 mg/m³. Damit ist der MAK-Wert deutlich unterschritten. Zusätzlich erfolgten in unseren internen Laboratorien Testreihen zur Ersatzstoffprüfung. Alle Versuche brachten nicht die gewünschten Erfolge. Ein vergleichbarer Ersatzstoff wurde nicht definiert. Bisher gab es keinerlei Hinweise auf berufsbedingte Erkrankungen von Mitarbeitern(regelmäßiger check up durch die Betriebsärztin). 	See responses #6, 8

It is not clear if the value of 0,19 mg/m3 relates to ADCA. From the description it seems that it refers to dust.
For ADCA no specific OEL (MAK) is available. From general dust measurements it cannot be concluded that no ADCA related adverse health effects are possible. 	
50	2012/10/17	Company
L&L Products
France	This study doesn’t mention at all the toxicology and eco-toxicology studies that the producers should have provided during registration. This is not fair to the producers and their consumers.

We are automotive part suppliers. We supply all the car producers. Without azodicarbonamide, we are not able to feed their supply chains and the car workshops will be disrupted.
	The property of concern is the respiratory sensitisation. All studies provided by the registrants for this endpoint have been evaluated for the Annex XV Dossier.

See responses #8, 9 	
49	2012/10/17	Individual
Hungary	When REACH was discussed in the Council in 2005, Germany advised to add respiratory tract sensitizers as additional group of substances in Art. 57 to be selected as an SVHC. See attached file, which contains all the changes advised by member states (MSs) in footnotes (see footnote Nu 58). It can clearly be seen from the file that 6 MSs opposed it, and finally was not accepted at the co-decision. All it means that the rule makers did not want to consider sensitizers as SVHCs. 	See response #2	
			See also:
Comment 49 attachment (Title VII. with footnotes.doc).doc		
48	2012/10/17	Company
L'Isolante K-Flex srl
Italy	We are a company that use ADCA since more than 20 years, with a local consumption of more than 5000 Kg/day, with 350 workers exposed (wearing personal protective equipment). All around the world, our company has 10 similar production units with totally 1500 workers. In the last 20 years no one case of respiratory sensitisation was reported on all workers that make regular medical checks. An official declaration in that sense (italian language, sorry!) is in attachment.

Reading the whole dossier, we dont see any clinical or research studies that proves ADCA's equivalent concern to a CMR classification, and only some case studies, most of them older than 20 years.	See responses #4, 6	
			Confidential attachment submitted		
39	2012/10/17	Company
Polifoam Plastic Processing Co. Ltd
Hungary	p.8: Although it is of no discussion that ADCA can't be declared as a harmless substance the dossier doesn't provide sufficient evidence for a classification of ADCA as a SVHC substance. The usage of ADCA for industrial application is well monitored and the reports on workers health monitoring show that a responsible usage with the support of todays PPE and RMM leads to no impact on workers health. ADC is in use at Polifoam Plastic Processing for 28 years and no ADCA related disease is reported for the company.
The number of reported cases of respiratory disease caused by ADCA in this Annex XV dossier is very limited concerning countries (2), number of cases (42) and the majority of the reported cases are from the period between 1989 and 1993 (35). 	See responses #1, 4,6

	
44	2012/10/17	Company
Trocellen Iberica S.A.
Spain	p.8: Although it is of no discussion that ADCA can't be declared as a harmless substance the dossier doesn't provide sufficient evidence for a classification of ADCA as a SVHC substance. The usage of ADCA for industrial application is well monitored and the reports on workers health monitoring show that a responsible usage with the support of todays PPE and RMM leads to no impact on workers health. ADC is in use at Trocellen Iberica for 38 years and no ADCA related disease is reported for the company.
The number of reported cases of respiratory disease caused by ADCA in this Annex XV dossier is very limited concerning countries (2), number of cases (42) and the majority of the reported cases are from the period between 1989 and 1993 (35). 	Repeats comment number 39	
			See also:
Comment 44 attachment (FREMAP_PDF013.pdf).pdf		
42	2012/10/17	Company
Trocellen Italiy S.p.A.
Italy	p.8: Although it is of no discussion that ADCA can't be declared as a harmless substance the dossier doesn't provide sufficient evidence for a classification of ADCA as a SVHC substance. The usage of ADCA for industrial application is well monitored and the reports on workers health monitoring show that a responsible usage with the support of todays PPE and RMM leads to no impact on workers health. ADC is in use at Trocellen Italia for 23 years and no ADCA related disease is reported for the company.
The number of reported cases of respiratory disease caused by ADCA in this Annex XV dossier is very limited concerning countries (2), number of cases (42) and the majority of the reported cases are from the period between 1989 and 1993 (35). 	Repeats comment number 39	
			See also:
Comment 42 attachment (letter Maltoni English.pdf).pdf		
43	2012/10/17	Company
Trocellen GmbH
Germany	p.8: Although it is of no discussion that ADCA can't be declared as a harmless substance the dossier doesn't provide sufficient evidence for a classification of ADCA as a SVHC substance. The usage of ADCA for industrial application is well monitored and the reports on workers health monitoring show that a responsible usage with the support of todays PPE and RMM leads to no impact on workers health. ADC is in use at Trocellen for 40 years and no ADCA related disease is reported for the company.
The number of reported cases of respiratory disease caused by ADCA in this Annex XV dossier is very limited concerning countries (2), number of cases (42) and the majority of the reported cases are from the period between 1989 and 1993 (35). 	Repeats comment number 39

For more detailed responses see Part I - Specific comments on the justification and Part II.
	
			Confidential attachment submitted		
40	2012/10/17	Member State
Sweden	We agree with the argumentation put forward in the Annex XV dossier and therefore consider C,C'-azodi(formamide) to be a SVHC substance of equivalent level of concern according to Article 57(f). The substance is a classified respiratory sensitizer which may cause severe and irreversible health effects, which clearly affect the quality of life of affected individuals and also high costs for society. It is difficult to establish safe exposure levels for respiratory sensitizers like C,C'-azodi(formamide), which is another reason for concern. Further, it is noted that this severe endpoint has not been taken into account by registrants in their chemical safety assessment in the Registration dossier.	Thank you for your  support.	
37	2012/10/17	Company
Hungary	page 17 table 3

Most of the datas in the proposal, but especially in the table 3 are 20-25 years old. The labour safety methods, standards were a lot weaker at that time. 
The datas regarding the occurance of asthma are basicaly from one country (UK) may be even from one or two companies. Most likely those companies in the UK 20 years ago had very poor labour safety. Why should the whole ADCA industry suffer, just because 1 or 2 companies in the UK were not able to hold basic rules.
Why aren't there some datas from other countries, which were producing ADCA at that time, for example Germany (Bayer) or Spain (Hebron)? Why only UK?
Currently there are no more producers of ADCA in the EU, there are only downstream users. 
Does the EU really wants to clear out all the downstream users as well and buy the products "Made in China"?	See responses #4,6,9

The provided confidential data refer to dust measurements which are as such not relevant for the specific health risks caused by ADCA.
	
			CONFIDENTIAL attachment removed		
36	2012/10/17	Industry or trade association
Germany	None	Repeats comment number 64
	
			See also:
Comment 36 attachment (ADCA Wallco Industry Statements.pdf).pdf		
35	2012/10/17	Industry or trade association
Finland	As we see there is no risk involved using ADCA on the process property safety equipments.	See response #6
	
34	2012/10/17	Individual
Italy	None	See response #6
	
			See also:
Comment 34 attachment (ADCA.pdf).pdf		
33	2012/10/17	Individual
Germany	Die im Annex XV Dossier veröffentlichen Daten sind veraltet und entsprechen nicht den deutschen Vorschriften des heutigen Industriestandards bezüglich Arbeitssicherheit, die von der Gewerbeaufsicht kontrolliert wird. Massnahmen zum Schutz vor Inhalation und Hautkontakt von ADC sind in den Sicherheitsdatenblättern festgelegt(Arbeitsschutzbekleidung, Atemschutz.ADC kommt heute als staubarmes, gecoatetes Pulver oder als polymergebundenes Granulat zum Einsatz.	See responses #4, 5, 6

	
32	2012/10/17	Member State
United Kingdom	From a technical perspective we are open to the idea that sensitisers could be added to the Candidate List and subsequently added to  Annex XIV, in cases where authorisation is identified as the most appropriate risk management option. However, the debate so far indicates that simply being classified as a sensitiser is not sufficient and that additional factors need to be taken into account. Exactly what these factors should be and the criteria that need to be applied to each factor still needs to be decided. Until this happens it is not possible to decide if ADCA is of equivalent concern and so is eligible for addition to the Candidate List. 

We note that some possible alternatives are also respiratory sensitisers e.g. OBSH which is also classified for mutagenicity (Muta Cat 2). It is not clear which of the alternatives that have been identified will be seen as viable alternatives on technical grounds. We do not wish to create a situation, where if the more hazardous product is the only viable alternative for certain processes, companies are choosing to move to more hazardous alternatives rather than apply for authorisation to use ADCA. It would therefore be useful to obtain better information on any substitution action before this substance is prioritised for Annex XIV. 	We understand that there is not yet a general agreement about the application of the criteria discussed with ECHA. However, we take the position that a substance which causes clear asthmatic effects, should be considered as SVHC. 

We also understand that at present no suitable alternatives are on the market. However, we think that the authorisation is a most appropriate route to motivate industry to develop such alternatives.

See also responses #1, 8	
61	2012/10/17	National NGO
Naturskyddsföreningen, Swedish Society for Nature Conservation (SSNC)
Sweden	The Swedish Society for Nature Conservation (SSNC) supports the proposal to categorise Diazene-1,2-dicarboxamide (C,C-azodi(formamide)) as a Substance of Very High Concern.
 
The SSNC is the largest and most influential environmental organisation in Sweden, currently with 192,000 members nationwide. The SSNC works to protect the natural environment and human health, and to strengthen global solidarity.	Thank you for your support. 	
31	2012/10/17	Individual
Italy	•	ADCA’s equivalent concern to a CMR classification has not been proved in the Austrian dossier	See responses #1, 6,7,8
	
			See also:
Comment 31 attachment (ECHA.doc).doc		
29	2012/10/16	Company
Germany	For the time being, ADCA is the best suited blowing agent for wallcovering manufacture. It is indispensable for the wallcovering industry. Potential health risks can be eliminated by suitable risk reduction measures.	See responses #6, 8	
27	2012/10/16	Industry or trade association
Belgium	The dossier is very very thin, it does not contain any stricking evidence that ADCA can be assimilated to a substance of equivalent concern (at the same level as a CMR Cat 1 for instance). The dossier does not address properly the efforts made by industry to protect the workers from the inhalation of ADCA although they are numerous, very simple to put in place and very efficient: use of granules instead of powder, use of ADCA in liquid dispersion, closed operation and strict application of the usual modern risk management measures like local exhaust ventilation, masks, gloves.
The study of alternatives is also lacking depth and is simply a list of the existing blowing agents available on the market, without any critical assessment whether they are suited for the various existing applications or not.	See responses #1, 6, 8

	
25	2012/10/16	Company
United Kingdom	None	Repeats comment number 64 
	
			See also:
Comment 25 attachment (ADCA Wallco Industry Statements.pdf).pdf		
24	2012/10/16	Company
Slovenia	Dear Madam/Sir!

Company Juteks d.d. is a PVC floor covering producer from Slovenia. We are using ADCA for more than 30 years. In all this time workers who came in contact with this substance were using personal protective equipment (gloves, goggles, masks/filters) and there is also local exhaust ventilation system. We are performing regular medical examination and there was never noticed correlation between ADCA and respiratory health problems (like asthma). We are also measuring the powder concentration in working environment and also never reached the limits. From our point of view ADCA is safe to use and we believe, there are no facts which will justify Austrian proposal to list ADCA on SVHC.

Best regards,
Joze Sadnik
R&D Product Manager
Juteks d.d.	See response #6	
23	2012/10/16	Company
Germany	Meteor is against the SVHC status of ADCA as state of the art for vulcanisation processes there are no detectable mass of ADCA.	We thank you for the provided monitoring and health data at workplace. We note that an increase of respiratory diseases was observed in work areas where ADCA and isocyanates are used. Exposure measurements performed showed very low concentrations of both ADCA and isocyanates. Therefore no relation between the observed dieseases and the monitored substances could be established.  
See also response #6	
			CONFIDENTIAL attachment removed		
22	2012/10/16	National NGO
IEW
Belgium	We support the nomination of this chemical to the Candidate List as a substance of very high concern	Thank you for your support.	
21	2012/10/16	Company
BIG floorcoverings NV
Belgium	- The dossier seems to be based on old(er) information: the Industry quickly adopts itself to HSE risks, therefore, one can state that the HSE risks are mitigated.	See responses #4, 6	
20	2012/10/16	Individual
Belgium	None	Repeats comment number 64	
			See also:
Comment 20 attachment (ADCA Wallco Industry Statements.pdf).pdf		
19	2012/10/16	Member State
Belgium	The following items are present in the Annex XV dossiers to substantiate that the substances fulfill the article 57(f) criteria:
•             Serious and permanent organ dysfunction is possible (can cause asthma and  allergic rhinitis/conjunctivitis).
•             The health effects are irreversible
•             The consequences for society are high
•             It is difficult to perform a concentration-based risk assessment
Therefore, the BE MSCA supports the identification of the  substance as SVHCs based on article 57(f) of the REACH regulation.	Thank you for your  support.	
16	2012/10/15	Industry or trade association
IGI - The Global Wallcoverings Association
Belgium	None	Repeats comment number 64	
			See also:
Comment 16 attachment (ADCA Wallco Industry Statements.pdf).pdf		
15	2012/10/15	Company
United Kingdom	Comments on the ADCA SVHC proposal	See responses #5, 6, 8, 9	
			See also:
Comment 15 attachment (ADCA.pdf).pdf		
13	2012/10/15	Company
L&L Products
France	Page 8 : Azodicarbonamide (ADCA) is almost registered in list of concerns and it looks like that it will eventually be registered in annex XV. However this dossier doesn’t report scientific evidence of ADCA being a very hazardous substance. 
What is more it shows that diseases can be avoided with protection.
Nowadays, no scientist study shows the evidence of ADCA being a dangerous substance.

ADCA is widely used in the industry. Some activities, like ours, strongly limitate the contact between the operators and the powder. What is more, because of the diversity of the industry, the ranges of use are numerous, so are the operator exposure levels. In our activity, we expect the operator exposure to be low, even lower than 1mg/m3 claimed by the British law.
There is no evidence of toxicity of final foam parts.
The inventory of different alternatives show finding alternative to ADCA will be long, time consuming and expensive.	See responses #1, 4, 6, 8, 9	
12	2012/10/15	Company
REHAU AG + Co.
Germany	pages 23 to 40
During production of foamed PVC-articles (e.g. foam core pipe etc.)azodicarbonamide is decomposed, so our end products don’t contain noteworthy quantities of this substance. The problem is to prove that the content is below 0.1% due to a lack of analytical methods for this concentration range. This may cause forwarding of mindless informations along the supply chain to avoid costs for analytical efforts.

Our suppliers informed us that they do not intend to bear any costs for authorisation of this substance. We are afraid that inclusion of this substance in the candidate list  or in annex XIV will endanger the further availability of this substance in EU.  This would cost many jobs in the production of foamed PVC-articles. Furthermore the production of foamed PVC-articles is saving resources due to the lower weight of these articles and due to the good energy efficiency of the production of these articles. Both positive points would fall away if the availability of azodicarbonamide cannot be ensured.	The measurements reported in the Annex XV Dossier achieved a quantification limit significantly below 0,1%.
See also responses #7, 9	
11	2012/10/15	Company
LEHVOSS Italia S.r.l.
Italy	We oppose especially to chapter 8 and 9 of the Annex XV dossier because we have other experiences with ADCA; the alternatives described in chp. 9 of the dossier are not suitable for our customers	See responses #6, 8	
10	2012/10/15	Company
LEHVOSS FRANCE Sarl
France	We oppose especially to chapter 8 / 9 of the Annex XV dossier because we have other experiences with ADCA; the alternatives described in chp. 9 are not suitable for our customers.	Repeats comment number 11	
9	2012/10/15	Company
Lehvoss UK Limited
United Kingdom	We oppose especially to chapter 8 and 9 of the Annex XV dossier because we have other experiences with ADCA; the alternatives described in chpt. 9 are not suitable for our markets	Repeats comment number 11 	
8	2012/10/12	Company
Continental AG / Beneke Kalicko AG
Germany	The Continental AG and its subsidiary Benecke-Kaliko AG strongly oppose to the dossier: “Identification of ADCA as SVHC” submitted by the Austrian Competent Authority due to following reasons:	See specific comments and responses	
7	2012/10/11	National NGO
Danish Consumer Council
Denmark	The Danish Consumer Council (DCC) supports the inclusion of the substance in the candidate list. The DCC wants dangerous chemicals in consumer products to be banned or at least minimized to the lowest possible levels. The inclusion of this substance to the candidate list is a strong signal to producers that the use of this substance should in time be stopped, and substituted with a less dangerous one.	Thank you for your support.	
18	2012/10/09	Company
Lehmann & Voss & Co. KG
Germany	We strongly oppose especially to p. 47 of the dossier (9. Risk-related information) because we have other experiences with ADCA , based on long-term usage/processing (see below)	See response #6	
6	2012/10/09	Member State
Germany	The German CA supports the proposed identification of C,C'-azodi(formamide) (ADCA) (CAS No. 123-77-3) as a Substance of Very High Concern according to Article 57(f) of the REACH legislation No 1907/2006. From our point of view ADCA fulfils the criteria of being of equivalent level of concern to CMR substances.	Thank you for your support.	
5	2012/10/07	Company
Zebra-chem GmbH
Germany	As a producer of Azodicarbonamide Masterbatches based in Germany we have read the Annex XV dossier, in the following comments “dossier” about the said material with high interest. As we are not used in preparing such reports we might not meet the exact requirements on form but we hope that the points we mention in our report will be understood from ECHA.

We do not agree with the dossier as ignores the following points and we will comment the single points more in detail in 

Part I, JUSTIFICATION
Part II, INFORMATION ON USE, EXPOSURE AND RISK

1.	JUSTIFICATION, SAFE PREPARATIONS: Current preparations and forms of Azodicarbonamide in the market are available (so called masterbatches) which are dust free. This properties are proved by the BAM (Bundesanstalt für Materialprüfung) and this proves are available and enclosed to this comments 
2.	QUALIFIED INDUSTRIAL JOBS: There is no market of Azodicarbonamide in the country of Austria, there is a market of several thousand tons per annum in Germany only, more then 10.000 tons in the EU and related to this market are quite a number of highly qualified industrial work places which would loose their jobs and companies which would stop paying taxes.
3.	APPLICATIONS AND RECYCLING INDUSTRIE OF PLASTIC: The use of Azodicarbonamide in the plastic pipe industry has lead to the development of a complete circle of PVC recycling n the European industry. This in return has increased the acceptance of this material to a very high level among the population.
4.	CURRENT KNOWLEGDE OF ALTERNATIVES: The list of alternative products (Number 8) is of theoretical nature only, none of this products work even close to a acceptable technical way, therefore there is currently no real alternative to Azodicarbonamide on the market.	See responses #5, 6, 8, 9	
			See also:
Comment 5 attachment (050920 - Prüfbericht Azodicarbonamid-Mikrogranulat-staubfreiheit.pdf).pdf		
4	2012/10/01	Industry or trade association
Pipelife France
France	The reported risks of respiratory sensitisation are strongly linked to the fine powder form described in the report. In our factories, ADCA is stocked in granule form before its utilisation in the process; the risks, especially in relation with respiratory sensitisation, for people manipulating the stocks are therefore very weak.	See response #5	
3	2012/10/01	Company
United Kingdom	This document is in reference to your consultation notification of 03/09/2012, Proposals to identify Substances of Very High Concern with specific reference to the chemical Diazene-1,2-dicarboxamide (C,C’azodi(formamide)).
For the purpose of this response this chemical shall be referred to by its commonly recognised industrial name of Azodicarbonamide (ADC).
Having handled and worked successfully with this chemical, without incident, for many years (in excess of 20) within the polymer industry, our company was surprised and shocked as to the proposal and more critically several areas of detail contained in the document. This material has a proven industrial track record and whilst it is a recognised respiratory sensitizer, thorough documentation, regulation and responsible care practice across the European industry has witnessed this material becoming a key ingredient in the manufacture of materials found across numerous areas of application which the public have become reliant upon. The safe use of this material has led to areas of technical advancement and environmental gain which would be at best highly difficult and at worst impossible to replicate using other proposed technologies listed in the document cited. 
This response makes no attempt to challenge the fact that ADC is a known respiratory sensitizer, it does however wish to bring to your attention the ways in which the industry has recognised this fact and voluntarily takes steps in minimising any potential risk to users of this product. The response however also wishes to challenge some of the proposed ‘technical alternatives’ to ADC as it is believed that a number of statements made are highly misleading and if followed would incur further safety and environmental step backs let alone significant and potentially irrecoverable disruption to production and the supply of technically suitable products to the market.   
To restrict the use of ADC as a foaming agent in the polymer field would have severe detrimental effect upon the industry, consumer choice, personal safety, application technical performance and the environment.
Thank you for your consideration to this response.     	See responses #6, 8, 9	
2	2012/09/19	Company
United Kingdom	Pages 8 - 19
Concerning the justification that ADCA exposure to workers and potentially to consumers is likely to occur under normal conditions of use; this is very unlikely.  
Within the supply chain there are several steps that the substance will undergo before it reaches the final article and eventually the consumer.
In the initial stages of manufacture and processing, industrial good working practices, safety equipment, COSHH assessments, dust extraction in the location of use and industrial exposure monitoring, will be in place to protect the exposed worker.
Manufacturing of paste dispersions for use in further product compound is additionally undertaken.  These pastes consist of solids dispersed within a plasticiser or other liquid carrier.  This is an activity that our company undertakes to produce a product that is supplied to several markets, such as wallcovering, flooring and siding manufacture.  These paste dispersions are liquid in form and as such the hazard of the product being dusty by nature is removed for further handling.  Almost all industrial manufacturers of plastic articles that are foamed using this chemical blowing agent use these paste dispersions or other polymer bound master batches.  These products are not hazardous to health via inhalation.
Further use and downstream products are also considered to be safe in this respect because the dusty nature of the chemical no longer exists. Therefore the claimed exposure potential to consumers and most workers is actually not a risk that is present.
Further processing of this chemical in paste or solid master batch form, via a thermoplastic product undergoing heating and shaping, results in the full decomposition of this chemical, producing gas.  It is this exothermic decomposition which forms the basis of selection of this chemical for foaming of thermoplastic articles.  When the articles are placed on the market, this chemical is fully decomposed and cannot present a risk via an inhalation route.
Therefore, the substance cannot and should not be identified as SVHC based on REACH Article 57f under an equivalent level of concern to CMR substances, because this dusty hazard is in most cases not actually present, except in very tightly controlled industrial uses, where the general public are not placed under any risk or exposed.	See responses # 5, 6, 7	
1	2012/09/19	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of Diazene-1,2-dicarboxamide (C,C-azodi(formamide)) as SVHC	Thank you for your support. 	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
71	2012/10/18	Company
GERFLOR
France	-	we can buy ADCA in a powder form. Our workers wear protective equipment (gloves, goggles, specific powder respiratory protection …). Moreover, the mixing is done automatically in a closed vessel, and our buildings are well ventilated.

-	we can buy also ADCA in a dispersion. The fine powder emissions are drastically minimized. In these ventilated locals, the mixing is also done automatically in a closed vessel.

-	our workers have medical check every year. They don’t develop asthma or other specific illness due to ADCA exposition.	See responses # 5, 6	
			See also:
Comment 71 attachment (1210 GERFLOR ADCA ECHA.doc).doc		
70	2012/10/18	Industry or trade association
European Plastics Converters (EuPC)
Belgium	Risk for human health workers (Comment: section 9, p 47-49 and  section 4.1.2.2.  page 14 to 18, Conclusion page 21 to 22)
No cases of asthma were reported across the converting industry. This seems to indicate that the classification of ADCA as a substance of equivalent concern to a substance of very high concern is probably not justified. One has to take into account the widespread use of risk management measures applied within the converting sector. 	
See response #6

			CONFIDENTIAL attachment removed		
69	2012/10/18	Industry or trade association
Wirtschaftsverband der deutschen Kautschukindustrie e. V. (wdk)
Germany	The dossier makes reference to cases limited to UK and The Netherlands. From a rubber production point of view both countries are not representative for reflecting the EU situation. The case studies reported in the dossier refer to extremely few cases, with no data on the exposure to ADCA at the workplace. Just reporting “higher concentrations as usual” (P.15 Paragraph 4) is far from any scientific approach of a risk evaluation. No one can evaluate the exposure situation as usual or as behind occupational standards. In the 

There is no clear distinction between the sectors where ADCA is used. The exposure scenario in the production of a substance can’t be compared with the use in e. g. rubber industry (4.1.2.3). The remark on the UK exposure limit not eliminating the assumed occupational asthma from ACAD exposure is missing evidentiary value because there is no verification of full compliance with the regulatory measures. 

Almost all reports made reference to had been published the early eighties of the last century which is about three decades ago. The period under review is very probably another decade ago. The exposure situation roughly 40 years in the past can’t be compared to the current situation. Otherwise progress made in industrial hygiene would be ignored. 

To a certain extend the dossier is rather based on assumptions than on scientific evidence. One prominent example can be taken from P.20 under the headline “Irreversibility”: “In very severe cases this could lead to death as immediate consequence of asthmatic attacks.” There is no source confirming this incident as a result of an exposition to ADCA. 

It is said (P.21), the delay of health effect is related to the sensitising potential of a substance, which means a very potent sensitizer evokes a quick reaction and health effects may occur with a significant delay if a less potent sensitizer is involved. The studies cited report on delays up to the years. This would be an indicator for ADCA having a low sensitising potential which is contrary to a substance of very high concern. One study (Normand – P.21 box “ADCA” last line) pays attention to previous sensitization as an accelerator for ADCA sensitization. This effect has not been investigated in deeper detail but can’t be disregarded. Most arguments forwarded in the dossier are based on symptoms, not reporting the full workplace situation and relevant details for evaluating the worker’s health conditions. 

The use of ADCA in the processing of articles intended to come into contact with foodstuff is prohibited (P.24). This however is not because of ADCA’s sensitising property but of the decomposition product semicarbazide suspect for being a carcinogen. This assumption has finally not been confirmed by EFSA. Nevertheless the prohibition of use has not been withdrawn. So far this issue is not a witness for an ADCA equivalent concern.

The information taken from the registration (P.24) without any further details is also not a proof for an elevated risk. The use as such does not give necessary information whether the substance is used as such or in a preparation and most important the ability of inhalation. Industrial uses as PROC 6 and 10 do not give any information on the real situation concerning exposition. Furthermore many processes are run in combination with exhaust ventilation or in closed systems. It is in the nature of PROC’s just giving a rough impression of substance use. The assumption made (“… might result in the highest inhalation exposure …”) is without any deeper relevance for the evaluation of the real exposure situation. Unfortunately the dossier is missing the risk management measures related to the PROCs.

Situation in rubber industry:
ADCA is used as a blowing agent for the production of cellular rubber articles. Companies are handling the substance at least from 1980 on. The physical appearance of ADCA is an oiled powder, paste or powder. There is no formation of dust because of the binder or the exhaust ventilation at the weighing station. After the mixing process of which is the second step in rubber processing ADCD is bound in the polymer matrix as all other rubber constituents as well. 
ADCD can’t be replaced for the processing of high quality cellular rubber. In the last twenty years not occupational health effects have been reported in entire German rubber industry.

Conclusion:
-	Due to the poor evidence of the dossier classifying ADCD a substance with equivalent concern the proposal has to be rejected.
-	This is underlined by the current exposure situation and the absence of health effects in rubber industry. 
-	In case of uncertainties in the ongoing decision process on the risk status of ADCA it is essential to evaluate the real situation and to come from assumptions to facts. 

German rubber industry would be ready to collaborate and to give useful input.	The Annex XV SVHC-Dossier contains available information on uses, exposure, risk and alternatives, including information received by other Member State authorities. It is neither required nor proportional for Member State Authorities to carry out a comprehensive risk assessment for the purpose of Art 59 of REACH. See also response # 6.

This discussion does not relate to the question as to whether ADCA fulfils Art 57 (f) of REACH.

See response #4

In the Annex XV dossier this is a general statement on irreversible effects of substances. The ACDA specific comment is given in the box below.

It is stated in the Annex XV dossier, that for very potent sensitizers the delay can be shorter than for less potent sensitizers. The delay for ADCA varies from right after first exposure up to 10 years after first exposure – no conclusion on potency can be drawn. The delay of effects does not necessarily affect the seriousness of the effect but it is of interest from a risk management point of view. A significant delay between exposure and effects warrants a higher level of concern been associated with the substance (risk management measures can be put in place as soon as a risk associated with a hazard has been identified). 

The formation of semicarbazide has not been taken into account when assessing the equivalent level of concern of ADCA.

Any information available has been used to describe the exposure situation at workplace. PROCs and the associated risk management measures are included in the confidential annex of the Annex XV dossier.

See also responses #5, 6, 8
	
68	2012/10/18	Member State
Ireland	The Irish CA agrees with the general criteria outlined in the Annex XV dossier for the identification of a substance as meeting the criteria of Article 57(f) for equivalent level of concern to CMRs, namely:
•	Inclusion of the substance on Annex VI to CLP as a respiratory sensitiser
•	The seriousness of the effects, in terms of serious and permanent organ dysfunction
•	Irreversibility of health effects
•	Consequences for society, in terms of cost of treatment and resulting occupational asthma
•	Difficulty in performing a concentration-based risk assessment.

However, the Irish CA notes that these criteria could be applied to all respiratory sensitisers and thus do not allow for identification of specific substances meeting Article 57(f) criteria “on a case-by-case basis”. 
Therefore, the Irish CA considers that the following point relating to the specific properties of ADCA may not support a justification for equivalent level of concern:

•	The Annex XV dossier provides some evidence that the introduction of a UK national maximum exposure limit (MEL) of 1 mg/m3 (8 hour limit value) in 1996 resulted in a significant reduction in the number of cases of respiratory disease attributed to ADCA reported to SWORD (1 case between 1996-2008). The Annex XV dossier notes that this reduction may be partially attributed to the setting of the MEL and to the cessation of production in the UK. However, if ADCA is still in use in the UK, then this would appear to indicate that the MEL is effective.	We understand that there is not yet a general agreement about the application of the criteria discussed with ECHA. However, we take the position that a substance which causes clear asthmatic effects should be considered as SVHC. See also response #1

Decrease in cases shows that measures have improved. However, this does not contradict the SVHC status which is based on intrinsic properties.

The decision to propose a restriction for targeted uses would require a comprehensive risk assessment of ADCA. This is neither a prerequisite for Art 59 of REACH nor does it seem a proportional effort at this step of decision making. In the RMO analysis we showed that in our opinion authorisation would be the most appropriate risk management measure.  	
			CONFIDENTIAL attachment removed		
66	2012/10/18	Other contributor
ADCA Task Force
Belgium	See document attached in section IV.
Title: ADCA Task Force comments on the proposal of Austria for identification of C,C’-azodi(formamide) (ADCA) as a Substance of Very High Concern	See response to comment number 66 under Part I - General comments on the SVHC proposal	
			See also:
Comment 66 attachment (Consolidated comments + ADCA Fact Sheet.zip).zip
CONFIDENTIAL attachment removed		
64	2012/10/18	Company
GRANDECO Wallfashion Group succursale France
France	p.17 UK manufacture ceased when the producer company was acquired by a German chemical company and the manufacture transferred to Germany. The use of ADCA as foaming agent in UK PVC wallcoverings manufacture continued and during the late 1980s increased significantly as foamed (‘blown’) wallcoverings became increasingly fashionable.
p.18 table 3. It is noted that there has been only one recorded case of a wallcovering process worker contracting respiratory disease attributed to wallcovering manufacture. There have been no recorded cases since 1989 despite the continued increase in the manufacture of blown PVC wallcoverings.	See response #6

	
			See also:
Comment 64 attachment (ADCA Wallco Industry Statements.pdf).pdf		
60	2012/10/18	Company
Germany	1.ADCA is mostly used as chemical blowing agent for rubber in our manufacturing process; during this application ADCA is almost completely decomposed so that in rubber products or articles for end consumers no relevant ADCA amounts will remain.
2. We supply ADCA mostly as a batched material in which the substance is homologenously embedded into a polymermatrix: during intended use no ADCA is released from the masterbaches as free substance.	See responses #5, 7	
59	2012/10/18	Company
S.C TROPAL ROMANIA S.R.L
Romania	With regards to the Justification: The case studies are quite old and only for 2 member countries (the UK and Netherlands). There are 3 comments regarding skin contact sensitization (based on non-conclusive data from the 1980's), and, as stated in Page 13 "No final conclusion on the skin sensitizing property of ADCA can be drawn on the basis of the availible data". 
With regards to the Respiratory issues: Animal studies showed nothing on the note (see page 14).
Human studies have not been done.
The Case studies are mainly from the UK( who, according to a report in "Medical News Today"  from 2004, have the highest rate of Ashtma in the World - 15-18% of the population-http://www.medicalnewstoday.com/medicalnews.php?newsid=5966), and Holland. If one considers data from the Canadian publication C-Health from 2007 that Asthma has increased 4-Fold over the last 20 years, or the World Health Organisation document ( from 2007) that in Switzerland Asthma has gone up 5-Fold in 25 years, then the case studies showing 28 cases of respiratory disease over the course of 22 years, does not seem so inconsistent.The noted lack of cases between 1996 and 2008 would also lead one to consider the accuracy of the data. Looked at in another way, in the last 15 years there was only one case of respiratory disease attributed to ADCA (as defined by SWORD) in the UK. 	ADCA is not classified for skin sensitisation. The reason for providing data for this endpoint in the Annex XV dossier is to give a complete picture of the sensitizing property of ADCA.
 
It is noted that in the criteria document prepared and published by the UK Health and Safety Executive (HSE) the following is stated: “In workplace health surveys, in addition to respiratory symptoms, the incidence of skin rash was also found to be greater amongst workers regularly exposed to azodicarbonamide. Therefore, although this aspect of the toxicology of azodicarbonamide has not been well investigated, the available data suggests that azodicarbonamide should be considered as a skin sensitiser” (EH 65/26 Guidance Note: Criteria Document for an Occupational Exposure Limit - ADCA (EM Ball, A Saleem. AO Ogunbiyi, K Wiley and JA Groves) 1996.)
For respiratory sensitisation at present there are no validated or widely accepted animal test protocols available therefore hazard identification is based on human data like case reports, records of worker´s experience and epidemiological studies (REACH Guidance R.8). Independent from asthma rates in the general population, the available studies showed a link between respiratory symptoms and exposure to ADCA.  The decrease of occupational asthma in national records may also be explained by the cease of production in UK about 20 years ago.	
			CONFIDENTIAL attachment removed		
58	2012/10/18	Company
Trelleborg Industri AB
Sweden	We have performed exposure measurements and medical evaluations. Measurements of short time exposure show a dust concentration of 0.09 mg/m³ in the area of the working places where ADCA is handled as a powder.  These values are far below the Swedish limit of 5 mg/m³ for dust.  Furthermore we are far below the limit of 3 mg/m³ for ADCA short time exposure as given by United Kingdom regulations. As to further minimize the amount of incorporated dust we have local     exhaust ventilations in place and the operators carry gloves and dusk mask as personal protective equipment. 	For ADCA no specific OEL is available. From general dust measurements it cannot be concluded that no ADCA related adverse health effects are possible.

See also response #6	
56	2012/10/18	Company
The Palziv Group
Israel	With regards to the Justification: The case studies are quite old and only for 2 member countries (the UK and Netherlands). There are 3 comments regarding skin contact sensitization ( based on non-conclusive data from the 1980’s ), and , as stated in Page 13 “No final conclusion on the skin sensitizing property of ADCA can be drawn on the basis of the available data”.
With regards to the Respiratory issues: Animal studies showed nothing of note (see page 14). 
Human Studies have not been done. 
The Case studies are mainly from the UK (who, according to a report in “Medical News Today” from 2004, have the highest rate of Ashthma in the World – 15-18% of the total population - http://www.medicalnewstoday.com/medicalnews.php?newsid=5966), and Holland. If one considers data from the Canadian publication C-Health from 2007 that Asthma has increased 4-Fold over the last 20 years, or the World Health Organisation document (from 2007) that in Switzerland Asthma has gone up 5-Fold in 25 years, then the case studies showing 28 cases of respiratory disease over the course of 22 years, does not seem so inconsistent. The noted lack of cases between 1996 and 2008 would also lead one to consider the accuracy of the data. LOOKED AT IN ANOTHER WAY: IN THE LAST 15 YEARS, THERE HAS ONLY BEEN 1 CASE OF RESPIRATORY DISEASE IN THE UK THAT WAS ATTRIBUTED TO ADCA(ACCORDING TO SWORD). 	Repeats comment number 59	
			CONFIDENTIAL attachment removed		
54	2012/10/18	Industry or trade association
UNIONPLAST - Federazione Gomma Plastica
Italy	In our opinion, the substance’s equivalent concern to a CMR classification has not been sufficiently proved in the Austrian dossier.	See response #1	
53	2012/10/18	Industry or trade association
SNCP/UCAPLAST
France	-	Le dossier présenté par les autorités autrichiennes pour demander le classement de l’azodicarbonamide dans la liste candidate ne semble pas reposer sur des données scientifiques solides. Nous demandons que soit menée une véritable étude sanitaire sur les conséquences de l’utilisation de l’azodicarbonamide avant qu’une quelconque décision ne soit prise sur cette substance.  De plus aucun de nos adhérents utilisant cette substance depuis de nombreuses années n'a identifié chez ses salariés de problèmes de santé relatifs à son utilisation.

(*) The dossier submitted by the Austrian authorities to request the classification of azodicarbonamide in the candidate list does not seem to be based on sound scientific data. We ask that a thorough study be conducted on the health consequences of the use of azodicarbonamide before any decision is taken on this substance. No more of our members use this substance for many years has identified among its employees health problems related to its use.	At the present stage of decision taking it is necessary to decide as to whether a substance is an SVHC on the basis of its inherent properties. In the Annex XV Dossier it was clearly demonstrated on the basis of reported cases that ADCA is capable of causing asthma. For this reason we do not consider the need for additional ADCA health studies.
See also responses #1, 6

(*) Google translation	
			See also:
Comment 53 attachment (2012.10.18 REACH_SNCP_UCAPLAST.pdf).pdf		
49	2012/10/17	Individual
Hungary	Remark 1:P13. Section 4.1.2. The classification of respiratory sensitisers is just reviewed in the 2nd ATP of CLP entering into force on 1st of December, 2012, 1.5 month time. It will not be a good decision to select a substance from the weakest classification category of this group, Category 1, into the candidate list.
Remark 2: P19. Section 6.1. The dossier quotes the legal text of REACH incorrectly:
Dossier: „substances for which there is scientific evidence of probable
serious effects to human health which give rise to an equivalent level of concern to CMR
substances”
REACH:  „substances — such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfill the criteria of points (d) or (e) — for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e).
It is clear that only those substances can be selected which have 
-	endocrine disrupting properties or
-	PBC, vPvB properties. No others, because there is no “etc” at the end of the list after „such as”.

Remark 3: If the understanding of the legal text by ECHA is different from mine above, an additional comment is that the dossier i.e. ADCA does not fulfill the requirement of equivalent level of concern stated in the „Guidance for the preparation of an Annex XV dossier on the identification of substances of very high concern”.
	ADCA does not provide a „Severe organ damage or major permanent functional changes in other organ systems (for example the lungs).” (3.3.3.2 Equivalent level of concern in relation to CMR P 30). Typically the symptoms last so long only till the exposure is present. The one exceptional case may be caused by other sensitizer: no data about the activity of the worker during this period. 	The term “such as” in Art. 57(f) implies that also other properties than endocrine disruption or PBT/vPvB properties may fall under Art 57(f), provided that there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e)
See also response #1

The “Guidance for the preparation of an Annex XV dossier” lists following factors to be considered when assessing an equivalent level of concern: seriousness of effects, the often irreversible nature of the effects, the consequences for society and the difficulty in performing concentration-based risk assessments.  
For ADCA both lessening of symptoms after removal of exposure as well as long lasting respiratory health effects are reported. The duration of exposure to ADCA seems to be a trigger for persistent symptoms. According to Kim, 2004 delay of avoidance from the onset of symptoms may be the most important cause of an incomplete recovery. Slovak, 1981 assumes that frequent rapid worsening of symptoms occurs if exposure continued. 	
			See also:
Comment 49 attachment (Title VII. with footnotes.doc).doc		
48	2012/10/17	Company
L'Isolante K-Flex srl
Italy	There is no recent workplace health evaluations, and nothing from countries where ADCA is, as far as we know, mostly used: ADCA largest quantities are used in the production of rubber foams and plastic foams, mostly in Italy, Germany, Poland, Belgium and Spain. The limited number of evaluations and national records cannot prove a potential impact on health or society as a whole, were last decade workers exposure scenario is completely changed due to the stricter adoption of personal protection devices	See responses #4, 6	
			CONFIDENTIAL attachment removed		
39	2012/10/17	Company
Polifoam Plastic Processing Co. Ltd
Hungary	p18, para 4: Polifoam Plastic Processing LTD. starts operation in the year 1984. The average number of employees are 80 (in 2012). The report of the work doctor shows no cases of respiratory disease attributed to ADCA. ( see attached report)	See response #6	
44	2012/10/17	Company
Trocellen Iberica S.A.
Spain	p18, para 4: Trocellen Iberica starts operation in the year 1974. The average number of operators being in contact with ADCA are 32 (in 2012). The report of the work doctor shows no cases of respiratory disease attributed to ADCA. ( see attached report)	See response #6	
			See also:
Comment 44 attachment (FREMAP_PDF013.pdf).pdf		
45	2012/10/17	Company
France	The assessment of ADCA as a substance of equivalent of concern (§6.1) is not proven in the Austrian dossier for the following reasons:
-	Quite all data given in the dossier are information dated before 1994 (especially 4.1.2.1a:  case studies – 4.1.2.2b: workplace health evaluations)   which resulted in the classification of ADCA as respiratory sensitizer 1. Since this date, the protection of workers was implemented systematically as defined in the safety data sheet of ADCA (respiratory protection mask, gloves, goggles) and in many cases local exhaust ventilation systems were installed. The information given in this dossier is not representative of the today situation. Medical checks are performed regularly in our production sites. No health problems related to ADAC manipulation were reported.
-	We don’t agree with the conclusion of Austrian experts done from the occurrence of occupational asthma from national records (§ 4.1.2.3 – paragraph 1: “Since then the diagnosis of occupational asthma decreased but did not cease completely as illustrated by table 3”). 
We note that in the SWORD database no case was reported from 2008 to 2011 and only 3 cases (10 %) from 1994 to 2008 i.e. during 14 years whereas 90% of the cases were reported between 1989 and 1994 i.e. during 5 years. 
In addition we note that no case was reported in OPRA and THOR –GP databases. 
In Netherlands (National centre for Occupational diseases) we note a very small number of cases reported (2) between 2002 and 2012. We don’t know when exactly these cases occurred and if it was really a consequence of ADCA exposition (it is only mentioned “casual exposure” in the report without confirmation it was the consequence of an exposure to ADCA).
The conclusion that diagnosis of occupational did not cease completely is for us a misinterpretation of the data given in this dossier. We think that last years data confirm the effectiveness of the dispositions taken in the industry to protect workers since the classification of ADCA as respiratory sensitizer 1. 

-	General comments on respiratory sensitizer are given in the item 6.1 (Substances of equivalent level of concern assessment). No specific information is given to explain why ADCA has to be treated as a specific respiratory sensitizer.

Regarding Human health hazard assessment (item 4), we would like to add that ADCA is not 
skin or eye irritant (see  references 1, 2, 3 below).
1.	U.S. National Library of Medicine: HSDB : 1,1'-AZOBIS(FORMAMIDE): CASRN: 123-77-3, 25.5.2004,
http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~zDsndo:1; last access 18.9.2012
        2.   OECD: SIDS INITIAL ASSESSMENT PROFILE: Azodicarbonamide : CAS 123-77-3. SIAM 12, 27-29 June
2001; http://webnet.oecd.org/HPV/UI/SIDS_Details.aspx?Key=8d456b9c-328a-44c1-abbd-
0c2cb28d9f5c&idx=0,
1.	European Chemicals Agency (ECHA): Registered Susbtances : CAS# 123-77-3.
http://echa.europa.eu/web/guest/information-on-chemicals/registered-substances
ADCA is not  carcinogenic (see  references 3, 4).
2.	Berufsgenossenschaft der chemischen Industrie (BG-Chemie): Diazendicarbonsäureamid. Bg-Nr 217, Heidelberg - 1993 
ADCA is not a reproductive toxicant (see reference 3)
ADCA has a low acute oral toxicity, low repeated oral dose toxicity and low dermal toxicity (see references 3).	

See responses #4, 6

See responses #4, 6

The cases recorded in the Netherlands are clearly linked to ADCA exposure, showing the potential of ADCA to induce occupational disease.

See also response #1

As stated in Annex VI of Reg. (EC) 1272/2008 and in the SVHC-Dossier ADCA is classified as respiratory sensitizer and not for other endpoints concerning human health. The references mentioned in the comment have been used as sources of information for the dossier.

The provided document (attachment) lacks any clear explanation of the tables and is thus not understandable.	
			CONFIDENTIAL attachment removed		
42	2012/10/17	Company
Trocellen Italiy S.p.A.
Italy	p18, para 4: There are three plants of Trocellen Italy located in Caponago, Volpago and Osio, starting operation between 1989 and 1994. The average number of operators being in contact with ADCA are 47 (in 2012). The report of the work doctor shows no cases of respiratory disease attributed to ADCA. ( see attached report)	See response #6	
			See also:
Comment 42 attachment (letter Maltoni English.pdf).pdf		
43	2012/10/17	Company
Trocellen GmbH
Germany	P.14, para 5: The case studies are from the 1980s, protective equipment was not the same as today, the conditions of use could not be compared. The study of Malo did not contain information on work place concentration nor on the particle size of ADCA, therefore it is not clear how high was the ADCA amount the workers were exposed to.

p14, para 6: The second worker has worked as a baker and may have suffered from the flour already. It is not clear if the problem occurs just because of the ‘dust’ itself, not specific related to the ADCA. No information of workplace concentrations and circumstances of handling the product are given.

P.15, para 1: One of the reported patients suffered from asthma because of his previous work as a baker. No information on work place concentration are given.

P.15, para 2: ‘Results of challenge studies are inconclusive’, this does not prove the correlation between desease and the contact to ADCA. 

P.15, para 5: The reported airborne concentrations of 2 to 5 mg/m3 is significantly higher than workplace measurements performed at Trocellen in the last 20 years. The maximum peak concentration measured was <0,25 mg/m3 (see confidential report ‘Staub_BG2008.pdf’, page 3 to 8). This can be calculated to 8h-time weighted average of <0,04 mg/m3. Other workplace measurements at Trocellen of the years 1991 and 2005 reports even lower concentrations. This shows that the exposure of the workers to ADC is not comparable to the situation at the time of the case studies been prepared.

P.16, para 2: The studies of Ahrenholz an Whitehead could not show differences in lung functions of ADC exposed persons and not exposed persons.
P16, para 3: The investigation does not allow to draw conclusions on the potential of ADCA causing respiratory sensitation.

P16, para 4: The study was disclosed in 1977, it could be stated that the working conditions, especially concerning PPEs and technical RMM have been improved dramatically, therefore this 35 year old study might not be representative for 2012 working conditions. Anyhow, this study is cited with ‘ …it is not clear if the lung reactions were due respiratory irritation or sensitation nor if other substances …were present’.

P17, para 1: Cite: ‘No detailed case reports are available’. This does not allow to draw a stringent conclusion on the fact that ADCA has caused the respiratory desease. Other fine particle dust like PVC powder, titanium dioxide, etc. might be of influence, too.

P17, table 3 : Excluding the accidents most cases are reported in the years 1989 to 1993. No reports between 1996 and 2008. If the drawn conclusion could be accepted that the mentioned cases of respiratory disease caused by ADCA are connected to the production of ADCA, it could be seen that the usage of the ADCA in the last 15 years  caused only 1 reported case. This allows the conclusion that the way how the industry is handling the ADCA is quite safe.

P18, para 2: The data bases OPRA and THOR-GP reported no ADCA related cases. Without any comment on the data consistency of the data bases it is visible that there are almost no reported cases since the middle of the 1990s.

P18, para 3: The two mentioned cases of the Netherlands does not show any industrial operator being involved. 
P18, : Although ADCA is widely used in other countries like Germany, Italy and Spain the report does not show any case studies from these countries.

severity of health effect
P19, para 4: The severity of health effect is based on the studies of Slovak, 1981, Malo, 1985, and Kim, 2004. For the majority of the reported cases (32 in UK) it is written that no descriptions of symptoms are available. Therefore these 32 cases could not be taken as an evidence for the severity of the health effect. There might be specific circumstances related to the two reports of Kim and Slovak because they are related to ADCA producing companies. Not considering all cases related to the ADCA manufacturing 30 years ago the number of reported respiratory induced cases attributed to ADCA could not be taken as statistically relevant.

P20, para 2: The irreversibility of sensitisation is mainly based on the two reports of the ADCA producing companies (Slovak, Kim). Other reports (Valentino, Alt, Ahrenholz, Whitehead, Ferris) stated that it was not possible to draw any conclusion about the potential for ADCAto cause respiratory sensitisation.

No safe concentration
P20, para 4: The reported animal studies (p.14, para 1) reports no indication of respiratory sensitisation on guinea pigs.  No classification reports using human data are available. Therefore it not clear how the conclusion of a non-existance of a ‘No safe concentration’ was made.

P21, para 2: It is written that respiratory diseases are well documented, e.g. in the SWORD database. This is in contradiction to the statement on p19, para5, concerning the SWORD database, where it is said that ‘No descriptions of symptoms are available’.

P21, para 2: The conclusion for the proposal for classification of ADCA as SVHC substance is based on the evaluations given in chapter 6.1. As mentioned above, none of the arguments concerning severity, irreversibility, delay of health effects and no safe concentration could be proven by detailed reports. Most of the cited studies didn’t contain detailed information and most of them are made in the 1980s. The largest number of reported cases are related to ADC production, which has been stopped a long time ago. No evidence was given concerning impact of ADCA on workers and consumers health.

	The case report by Malo, 1985 showed ADCA specific late asthmatic reactions in two workers exposed to ADCA. Lung provocation studies showed ADCA as the causing agent even though the concentrations of ADCA and the particle size were not specified. 

Normand, 1989 describes 4 cases, two of them have previously been employed as bakers. One suffered from eczema of hands and forearms at the bakery but it was not stated whether he also experienced respiratory symptoms. After 12 years at the plastic factory (where “general” dust exposure may have already occurred) he was moved onto duties bringing him into contact with ADCA, where he developed symptoms immediately. Challenge with ADCA was positive confirming a connexion between ADCA and asthma symptoms. The second baker has left former employment because of asthma and eczema. Respir. symptoms occurred during first ADCA exposure. As no challenge was carried out for this worker no final conclusion (if he was reacting to ADCA or another agent) can be drawn.
ADCA has been used as flour improver and there exists the possibility that they had been exposed to the substance in their previous employment. 

Valentino, 1985: For the first challenge test ADCA was heated but the airborne ADCA concentration was not determined. Therefore the negative finding of this challenge test is questionable. During the second challenge (return to work study) Forced expired volume (FEV) was reduced but airborne concentration of ADCA was not measured. Therefore this study gives some evidence but no final conclusion can be drawn.

Thank you for the information on ADCA exposure in your company. It is noted that the exposure reported in Slovak, 1981 is within the range of exposure concentration described in exposure scenarios in the CSR which is the relevant basis for the Annex XV dossier. See also responses #4, 6.

Ahrenholz, 1985a and Whitehead, 1987 clearly demonstrated a link between respir. symptoms and work in the injection mould. A cross-sectional evaluation of lung function of 227 employees revealed no significant difference in FEV and Forced Vital Capacity (FVC). For 17 injection mould operators, where personal sampling data were available, a statistically significant reduction in FEV and FVC occurred, The potency of ADCA cannot be evaluated on the basis of the available data. No methods and no data to derive safe concentrations is available so far (REACH guidance R.8)

Ferris, 1977 could not eliminate the possibility of confounding factors but anamneses indicate ADCA as the agent causing respiratory symptoms. See also responses #4, 6.

For cases reported to national databases no detailed case descriptions were available. However the cases have been reported by physicians who identified a link between ADCA exposure and occupational asthma. For each of these cases ADCA is recorded as the causal agent.

See response #6

Comment acknowledged.

The cases recorded in the Netherlands are clearly linked to ADCA exposure, showing the potential of ADCA to induce occupational disease. 
All publicly available data was used for the compilation of this Annex XV dossier.

The severity of ADCA health effects is characterized by asthmatic reactions (Kim, 2004; Malo, 1985; Normand, 1989) and symptoms shifting from the upper to the lower respiratory tract “(allergic march”) (Valentino, 1985; Alt, 1988). Slovak, 1981 showed a high asthma prevalence (18,5%). The documented cases in national records underline that ADCA induced occupational asthma – a severe health effect.

The induction phase of sensitisation is irreversible per se. In the two cases  (Kim, 2004; Slovak, 1981) exposure has been prolonged after symptoms occurred – resulting in persistent symptoms. 
The comment on the other reports is not substantiated – see responses above.

For respiratory sensitisation at present there are no validated or widely accepted animal test protocols available therefore hazard identification is based on human data like case reports, records of worker´s experience and epidemiological studies
Currently available methods and the data available for ADCA (no dose response relationship can be established) do not allow determination of a threshold and the establishment of a no-effect-level (REACH guidance R.8) 

The connection between ADCA exposure and occupational asthma is well documented in available studies and the national databases where ADCA is recorded as the causal substance for occupational asthma. Case descriptions would give more details on specific symptoms (anamnesis) and workplace exposure but the link between ADCA exposure and asthma has been documented by the reporting physician.

All available studies are described in the dossier. The quality of data and the documentation behind each case differ but all together they support the equivalent level of concern of ADCA.

The skin irritation test provided in the attachment does not provide any information on the sensitizing property of ADCA.	
			CONFIDENTIAL attachment removed		
46	2012/10/17	Company
Sekisui Alveo AG
Switzerland	a)	p. 13 - 4.1.1 Skin sensitisation:
We agree on the conclusion of the dossier's authors that no skin sensitising property of ADCA can be drawn on basis of the presented data. Especially the case report of Yates (1988) concerning the external otitis of an textile worker does not proof any harmful effect of ADCA-containing products. Our tests resulted clearly in no skin sensitising effect of our foam products blew via thermal decomposition of ADCA as described below.
Due to registration in the US FDA Drug Master File, Sekisui Alveo initiated a toxicological assessment of some crosslinked polyethylene foams which are produced with ADCA foaming agent. These foams are intended for the application in the fields of medical devices (e.g. ostomy pouches), medical and pharmaceutical packaging, orthopaedics (e.g. inlays with supporting and resting function), sanitary/incontinence towels, ECG pads, plaster (e.g. transdermal pouches, medical tapes), cap seals (sealing devices for glass and plastic container closures) and food packaging (Non-EU).
In consideration of the intended application of our customers (downstream users), the allergic potential (Local Nymph Node Assay (LLNA) in mice), primary skin irritation (study on rabbits, 4-hour semi-occlusive application) and cytotoxicity assay in vitro (XTT-Test) have been studied by accredited laboratories in Switzerland and Germany in 2000, 2009 and 2010. In reference to the confidential test documents provided in Chapter V (Confidential Attachment 1, pages 1 - 34) the general results have been as follows:
•	Allergic potential: NO SKIN SENSITIZER
•	Primary skin irritation: NOT IRRITATING TO RABBIT SKIN
•	Cytotoxicity assay in vitro: NO TOXIC EFFECT OBSERVED following incubation with extracts of up to the highest tested concentrations, the foam products did NOT POSSESS A CYTOTOXIC POTENTIAL

Our tests support the conclusion that our products do not show any harmful effect on skin.
b)	p. 15 - 4.1.2.2b Workplace health evaluations:
Sekisui Alveo does not attempt to challenge the fact that ADCA is a known and well documented respiratory sensitizer. Furthermore we would like to bring your attention to the actual ADCA-handling situation in the affected industries. In this context it seems doubtful that studies and investigations which have been performed almost 30 years ago could reflect the actual health situation of employees who regularly work with ADCA or with ADCA-containing products. In lack of any information about applied Risk Management Measures (RMM) Personal Protection Equipment (PPE) in most of the studies, we assumed that the examined employees have been fully exposed to ADCA present in breathable air as described in the investigation of Slovak. This situation is far away from the actual exposure and work situation in the ADCA-handling industry.
Latest in the early 1990's, when the concern has been published that ADCA may be a respiratory sensitizer, all affected industries implemented appropriate measures in order to protect their workers' health. As an example, our production plants installed Local Exhaust Ventilation at all working places where ADCA is applied (blender hatches and weighting scales) and all operators who are working at these places are obliged to wear P3 respirators and gloves. Details on detected working exposure values and on exposure scenarios are given in Chapter V (Confidential Attachment 2, pages 35 - 58).
Additionally, since that time, our plants are regularly monitoring their employee's health (every 6 years in plant Netherlands, every 6 months in plant United Kingdom) in particular by examination of change in lung performance, for details see also Chapter V (Confidential Attachment 3, pages 59 - 64). In conclusion, for about 20 years all studies showed that our employees' health has not been affected negatively by handling ADCA or ADCA-containing products. Thus our taken measures against unprotected exposure to ADCA in breathable air are efficient. Comparable measures are nowadays common practice in the ADCA-handling industry.	Thank you for this additional information on properties of an ADCA containing product. As stated in the test protocol on skin sensitisation (attached to the comments), the LLNA was carried out with an extract of a product consisting of polyethylene foam. 
However, no chemical analysis
of this foam extract has been performed and it is not known if at all and in which concentration ADCA was present in this extract. Therefore, the results are not considered further for the support document.

See also responses #4, 6
	
			See also:
Comment 46 attachment (Attachment to Comments - Chapter IV.pdf).pdf
CONFIDENTIAL attachment removed		
47	2012/10/17	Company
Belgium	1.	The evidence to classify ADCA as SVHC is limited:
a.	The mechanism of the sensitising effects of ADCA is not known
b.	No DNEL, NOAEL is established
c.	There are no conclusive animal studies
d.	It is not proven ADCA is a very potent sensitiser
	For the classification of ADCA all available animal and human data have been taken into account. They were judged sufficient by an EC expert group to show that ADCA induces respiratory sensitisation.

No validated animal study protocol is currently available for classification purposes and for derivation of NOAELs. 
See also responses  1, 6, 8	
			See also:
Comment 47 attachment (20121008 ADCA public version.docx).docx
CONFIDENTIAL attachment removed		
37	2012/10/17	Company
Hungary	page 15-19 severity of health effect, no safe concentration

Our company is using an oil dampen, so called wet version of ADCA. We are working with ADCA for 10 years. As you can see in the attached medical information, we never had a case with asthma over this years.
In the other attachement you can see that the respirable dust level by our company is very low.
Our case shows that already the simple action, that we are using a "dust-free" wet version of ADCA make the use of ADCA safe.	See responses #5, 6	
			CONFIDENTIAL attachment removed		
36	2012/10/17	Industry or trade association
Germany	p.17 UK manufacture ceased when the producer company was acquired by a German chemical company and the manufacture transferred to Germany. The use of ADCA as foaming agent in UK PVC wallcoverings manufacture continued and during the late 1980s increased significantly as foamed (‘blown’) wallcoverings became increasingly fashionable.
p.18 table 3. It is noted that there has been only one recorded case of a wallcovering process worker contracting respiratory disease attributed to wallcovering manufacture. There have been no recorded cases since 1989 despite the continued increase in the manufacture of blown PVC wallcoverings.	Repeats comment number 64	
			See also:
Comment 36 attachment (ADCA Wallco Industry Statements.pdf).pdf		
34	2012/10/17	Individual
Italy	p.17 UK manufacture ceased when the producer company was acquired by a German chemical company and the manufacture transferred to Germany. The use of ADCA as foaming agent in UK PVC wallcoverings manufacture continued and during the late 1980s increased significantly as foamed (‘blown’) wallcoverings became increasingly fashionable.
p.18 table 3. It is noted that there has been only one recorded case of a wallcovering process worker contracting respiratory disease attributed to wallcovering manufacture. There have been no recorded cases since 1989 despite the continued increase in the manufacture of blown PVC wallcoverings.	Repeats comment number 64	
			See also:
Comment 34 attachment (ADCA.pdf).pdf		
32	2012/10/17	Member State
United Kingdom	From the information in the Annex XV dossier, it is not clear whether the cases that have been reported in recent years indicate an ongoing risk that is not effectively managed by the current legislative regime or reflect local failures to implement the correct controls. 	We are aware of different opinions of appropriate risk management measures. It is our opinion that authorisation would be the best instrument ensuring that all companies apply the same level of exposure control until an appropriate alternative is available.	
31	2012/10/17	Individual
Italy	•	Risks from ADCA use has been adequately addressed through a use of personal protective equipment, including closed systems	See responses # 6,7, 8	
			See also:
Comment 31 attachment (ECHA.doc).doc		
29	2012/10/16	Company
Germany	p.17 UK manufacture ceased when the producer company was acquired by a German chemical company and the manufacture transferred to Germany. The use of ADCA as foaming agent in UK PVC wallcoverings manufacture continued and during the late 1980s increased significantly as foamed (‘blown’) wallcoverings became increasingly fashionable.
p.18 table 3. It is noted that there has been only one recorded case of a wallcovering process worker contracting respiratory disease attributed to wallcovering manufacture. There have been no recorded cases since 1989 despite the continued increase in the manufacture of blown PVC wallcoverings.	Repeats comment number 64	
27	2012/10/16	Industry or trade association
Belgium	P13-18: most if not all data mentioned are old and thus are related to ways of working and protecting the workers that do not correspond any more to the current situation within industry. Indeed Risk Management Measures have been widely introduced that allow to protect the workers from the level of exposure that was existing at that time. It is also worth to note that many reported cases are related to the manufacture or the milling of ADCA, operations that do no longer take place in the EU as all the production is done outside the EU.
Furthermore, the number of cases reported (one since 1996) seems to support the idea expressed here above that efficient RMM have been out in place to control the exposure of workers in case of accidental spillage or release of ADCA.

It is finally worth noting that no animal study has been able to confirm respiratory sensitisation due to the inhalation of ADCA.	See responses #4, 6

At present no validated animal study protocol for respiratory sensitisation is available. The case reports and health surveys cited in the Dossier have been used and judged to be of sufficient quality by EC, OECD and UK HSE to conclude on the respiratory sensitising properties of ADCA in humans.	
26	2012/10/16	Industry or trade association
European Council of Vinyl Manufacturers
Belgium	Conclusion (pages 21 and 22): The evidence cited to justify the conclusion “C,C'-azodi(formamide) fulfils the criteria set out in REACH Article 57 (f) of being a substance for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern.” is weak. The recent cases of occupational asthma are almost non-existent. Over the recent decades there has been a fall to almost zero in the number of workers developing asthma due to a suspected exposure to ADCA. All Downstream Users conduct regular medical checks proving this. The Annex XV dossier mentions a case in 2008. The previous one mentioned dates back to 1996. This is probably because ADCA is mainly used either as granulate or dispersion in a liquid form, in which case no exposure to the fine powder is expected. 
If used in a powder form, either closed systems have been installed or in the case of open or semi‐open systems, personal protective equipment such as gloves, goggles and masks are used in the production steps where the most important exposure can be expected such as manual discharge of bags or mixing. In those cases a local exhaust ventilation has also generally been installed	See responses #5, 6

	
25	2012/10/16	Company
United Kingdom	p.17 UK manufacture ceased when the producer company was acquired by a German chemical company and the manufacture transferred to Germany. The use of ADCA as foaming agent in UK PVC wallcoverings manufacture continued and during the late 1980s increased significantly as foamed (‘blown’) wallcoverings became increasingly fashionable.  p.18 table 3. It is noted that there has been only one recorded case of a wallcovering process worker contracting respiratory disease attributed to wallcovering manufacture. There have been no recorded cases since 1989 despite the continued increase in the manufacture of blown PVC wallcoverings. 	Repeats comment number 64	
			See also:
Comment 25 attachment (ADCA Wallco Industry Statements.pdf).pdf		
23	2012/10/16	Company
Germany	Meteor is using ADCA since 1981 as a blowing agent in ealstomers. We use an oil-treated form, so there is no dust of ADCA in the working area. During the vulcanisation-process above 200°C the blowing agent decompose completely. No relevant amounts of the blowing agent will remain in the elastomer.	See response #5 and response under Part I – General comments	
			CONFIDENTIAL attachment removed		
21	2012/10/16	Company
BIG floorcoverings NV
Belgium	- page 13: in our workers monitoring scheme, no reports were made on skin sensitisation.
- page 17-18: most information seems outdated; no recent cases are reported.
	See responses #4, 6	
20	2012/10/16	Individual
Belgium	p.17 UK manufacture ceased when the producer company was acquired by a German chemical company and the manufacture transferred to Germany. The use of ADCA as foaming agent in UK PVC wallcoverings manufacture continued and during the late 1980s increased significantly as foamed (‘blown’) wallcoverings became increasingly fashionable.
p.18 table 3. It is noted that there has been only one recorded case of a wallcovering process worker contracting respiratory disease attributed to wallcovering manufacture. There have been no recorded cases since 1989 despite the continued increase in the manufacture of blown PVC wallcoverings.	Repeats comment number 64	
			See also:
Comment 20 attachment (ADCA Wallco Industry Statements.pdf).pdf		
16	2012/10/15	Industry or trade association
IGI - The Global Wallcoverings Association
Belgium	p.17 UK manufacture ceased when the producer company was acquired by a German chemical company and the manufacture transferred to Germany. The use of ADCA as foaming agent in UK PVC wallcoverings manufacture continued and during the late 1980s increased significantly as foamed (‘blown’) wallcoverings became increasingly fashionable.

p.18 table 3. It is noted that there has been only one recorded case of a wallcovering process worker contracting respiratory disease attributed to wallcovering manufacture. There have been no recorded cases since 1989 despite the continued increase in the manufacture of blown PVC wallcoverings.	Repeats comment number 64	
			See also:
Comment 16 attachment (ADCA Wallco Industry Statements.pdf).pdf		
13	2012/10/15	Company
L&L Products
France	Page 13 : No evidence of skin sensitization with ADCA has been found.

Neither respiratory sensitization went to evidence during scientific studies on animal test or clinical test. The respiratory hazard suspicion relies only on human case studies, i.e. observation reports, which can be subjectively interpreted.

Page 14a : Some facts related in the case studies show that suitable protection can avoid any risk of asthma reaction and even help the workers to recover.

Most of the studies described in the part I do not demonstrate correlation between exposure to ADCA and asthma.  All the case studies, except one, relate the disease of people who were directly exposed to ADCA. What about people wearing protection? They are not affected.

Page 19 : The 5 different criteria used to define a CMR substances  are not so obviously fulfilled by ADCA:
-	Severity of health effect :  asthma. No carcinogenic effect nor reprotoxic ; observations show that a suitable individual (PDE) or collective(extraction)protection avoid health hazard.

-	Irreversibility : some evidence of long time effect are related, but not irreversibility

-	No safe concentration : no study made to prove that there is no safe concentration.
-	

Delay of health effect : page 21 : “It is felt that a significant level”. There is actually no scientific data.

Therefore as a conclusion : 
-	No evidence of health hazard with clinical study
-	Protection can avoid reaction
-	CMR criteria not fulfilled
-	Our experience : use of mask - no allergy reported over 15 years activity in Europe. The people who were involved in operations having close contact with ADCA are : 
o	Lab technicians
o	Compound production operators
This means 20 % of our staff. Up to now no disease was reported.	ADCA is not classified for skin sensitisation. The data for this endpoint are presented in the Annex XV dossier to give a complete picture of the sensitizing property of ADCA.
In the criteria document prepared and published by the UK Health and Safety Executive (HSE) the following is stated: “In workplace health surveys, in addition to respiratory symptoms, the incidence of skin rash was also found to be greater amongst workers regularly exposed to azodicarbonamide. Therefore, although this aspect of the toxicology of azodicarbonamide has not been well investigated, the available data suggests that azodicarbonamide should be considered as a skin sensitiser” (EH 65/26 Guidance Note: Criteria Document for an Occupational Exposure Limit - ADCA (EM Ball, A Saleem. AO Ogunbiyi, K Wiley and JA Groves) 1996.)
For respiratory sensitisation at present there are no validated or widely accepted animal test protocols available therefore hazard identification is based on human data like case reports, records of worker´s experience and epidemiological studies (REACH Guidance R.8). The referred studies have also been evaluated and considered of sufficient quality by the EC working group on classification and labelling, by OECD (CICAD 16) and by HSE UK for the purpose of deriving a national maximum exposure limit value.

Normand, 1989 described a case where the patient remained at his job but with improved working conditions and only vague respiratory symptoms. However, accidential reexposure resulted in an asthmatic reaction. However it is noted that arguments about the control of exposure and risks are not relevant for the decision on the equivalent level of concern of ADCA. See also response #6.

For some individuals bronchial challenge studies with ADCA were performed (Malo, 1985; Normand, 1989) demonstrating a link between ADCA exposure and respiratory effects. In the documented workplace health surveys, individuals exposed to ADCA more frequently reported respiratory symptoms than individuals who were not regularly exposed to ADCA. In the most comprehensively reported study (Slovak, 1981), 18.5% of the workforce were diagnosed as having occupational asthma clearly related to ADCA. Ahrenholz, 1985a also demonstrated a link between respiratory effects and ADCA exposure.  

See responses # 1, 6

In most of the cases exposure was stopped after occurrence of first symptoms. But other studies show that prolonged exposure results in progression of symptoms and long lasting respiratory health effects. (Slovak, 1981; Kim, 2004) 
Unfortunately the studies give only information for a particular period of time. For Slovak, 1981 for example 2 workers are described which still suffered from symptoms after 7 years from removal of exposure.- no further investigation is reported.

Currently available methods and the data available for ADCA do not allow determination of a threshold and the establishment of a DNEL (REACH guidance R.8) 

The first paragraph in this chapter gives some general statements on the delay of health effects. It is stated that - in general – a delay between exposure and effects warrants a higher level of concern. For ADCA 
available literature documents that the appearance of respiratory symptoms varied from right after exposure up to 10 years. So there is scientific data demonstrating a delay of effects.	
12	2012/10/15	Company
REHAU AG + Co.
Germany	pages 13 to 22:
Azodicarbonamide isn’t produced within EU. We don’t use it as a dusty powder. We buy  non dusting granulated concentrates  which are produced by specialized producers handling the powder in closed systems. The dangerous property “May cause sensitization by inhalation” is related to dust of this material only. So nobody in our production is taking a risk using this substance.

A PVC foam core pipe is extruded with an inner and an outer layer of not foamed rigid PVC. Even if traces of ADCA would survive processing no consumer will be able to come into contact with these traces due to the coextruded layers. 	See responses #5, 6, 7	
8	2012/10/12	Company
Continental AG / Beneke Kalicko AG
Germany	1.)The case studies mentioned in the proposal are several decades old. No data is given on the concentration of ADCA in the breathable air and on which safety equipment had been applied. Therefore, the data from these case studies is non transferable to the actual situation of working places in the EU.
2.)There is no indication of an increased illness level in our manufacturing process. On our shop floor, ADCA is handled for decades under safety precautions like local exhaust ventilations and personal protective equipment (e.g. gloves and dusk masks). We do not observe any increased illness rates, especially not on asthma cases in relevant work places where ADCA is processed.	See responses #4, 6

	
5	2012/10/07	Company
Zebra-chem GmbH
Germany	To 1 JUSTIFICATION; SAFE PREPARATION:
Because of the fact that Azodicarbonamide is a powder product and the dust is related as the threat for the use (the harmlessly of all other properties of Azodicarbonamid is undisputed) he industry has started to produce Azodicarbonamide preparations in the last 15 years which have been proven to be safe and absolutely dust free. These properties have been tested by the German BAM (Bundesanstalt für Materialprüfung) and the certificate of this test is enclosed as IV Attachment of non-confidential information. It is requested from the consuming industry that the fact will be appreciated that Azodicarbonamid preparations which are dust free (and the dust is the only concern) are available on the market, that they work well and they are a proven technology for more then 10 years.	
See response #5	
			See also:
Comment 5 attachment (050920 - Prüfbericht Azodicarbonamid-Mikrogranulat-staubfreiheit.pdf).pdf		
3	2012/10/01	Company
United Kingdom	We fully respect that ADC is a known respiratory sensitizer. We do however have concerns relating to the Annex XV dossiers perceived nature of risk and handling of this material in an industrial environment within the polymer industry. Please see comments in part II.	See response #6	
2	2012/09/19	Company
United Kingdom	Pages 8 - 19
Concerning the justification that ADCA exposure to workers and potentially to consumers is likely to occur under normal conditions of use; this is very unlikely.  
Within the supply chain there are several steps that the substance will undergo before it reaches the final article and eventually the consumer.
In the initial stages of manufacture and processing, industrial good working practices, safety equipment, COSHH assessments, dust extraction in the location of use and industrial exposure monitoring, will be in place to protect the exposed worker.
Manufacturing of paste dispersions for use in further product compound is additionally undertaken.  These pastes consist of solids dispersed within a plasticiser or other liquid carrier.  This is an activity that our company undertakes to produce a product that is supplied to several markets, such as wallcovering, flooring and siding manufacture.  These paste dispersions are liquid in form and as such the hazard of the product being dusty by nature is removed for further handling.  Almost all industrial manufacturers of plastic articles that are foamed using this chemical blowing agent use these paste dispersions or other polymer bound master batches.  These products are not hazardous to health via inhalation.
Further use and downstream products are also considered to be safe in this respect because the dusty nature of the chemical no longer exists. Therefore the claimed exposure potential to consumers and most workers is actually not a risk that is present.
Further processing of this chemical in paste or solid master batch form, via a thermoplastic product undergoing heating and shaping, results in the full decomposition of this chemical, producing gas.  It is this exothermic decomposition which forms the basis of selection of this chemical for foaming of thermoplastic articles.  When the articles are placed on the market, this chemical is fully decomposed and cannot present a risk via an inhalation route.
Therefore, the substance cannot and should not be identified as SVHC based on REACH Article 57f under an equivalent level of concern to CMR substances, because this dusty hazard is in most cases not actually present, except in very tightly controlled industrial uses, where the general public are not placed under any risk or exposed.	Repeats comment number 2  (general part)	

PART II: Comments and responses to comments on uses, exposures, alternatives and risks

Specific comments on use, exposure, alternatives and risks
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
71	2012/10/18	Company
GERFLOR
France	-	ADCA content inside the products is very low (less than 1%), and never in the surface. The main use is to introduce it in the backing of the flooring in order to produce foam layer for acoustic properties. PVC conversion occurs around 200°C. At this temperature ADCA decomposes to a nearly 100% degree in gazes (35%, including mainly N2 and CO) and in solid residues (65%). 

Possibly remaining ADCA and its non-gaseous decomposition products are embedded in the polymer matrix and are not available as powedery product raising occupational concerns
So our products users are not in contact with ADCA powder
Moreover, analyses on our products confirmed this high degree of decomposition: an official laboratory measured less than 0,1% of  residual ADCA in our floorings

-	Potential alternatives have been tested, but the properties are lower to ACDA ones and the substitute present more hazardous risk phrases	See response #7

See response #8	
			See also:
Comment 71 attachment (1210 GERFLOR ADCA ECHA.doc).doc		
70	2012/10/18	Industry or trade association
European Plastics Converters (EuPC)
Belgium	Uses in the plastics industry (Comment section 7.2, p.23 and following):

The survey confirmed that ADCA is widely used as blowing agent for most common plastics such as polyolefins (PE, PP, TPO), PVC, PS, and HIPS, as well as TPU, EVA and EPDM.

 ADCA is used in a wide range of processes including calendering, coating, spread coating, injection, blowing and extrusion.

ADCA is used in three main forms by plastics converters: granulate, dispersion into a liquid and as a powder. The first two forms are prepared in dedicated facilities by compounders.  
Information on alternatives (Comments section 8 p. 40-45):

Reports on testing main alternatives conclude that those do not meet the required technical properties 	Thank you for the information on the survey conducted by your association.

We have contacted your association when we prepared the dossier but did not receive an answer to our questions concerning global figures, alternatives, and ADCA residues in time to be used in the dossier to reflect the actual European situation.

See also responses #5, 6, 7, 8 and responses to comment number 70 of Part I – General comments	
			CONFIDENTIAL attachment removed		
67	2012/10/18	Company
Endutex - Revestimentos Têxteis S.A.
Portugal	pag 34	See responses #5, 6, 8, 9	
			See also:
Comment 67 attachment (Endutex Comments on ANNEX XV proposal to include ADCA as SVHC substance.pdf).pdf		
65	2012/10/18	Company
France	L'AZB ( Diazene-1,2-dicarboxamide (C,C'-azodi(formamide)) est utilisé dans le secteur nucléaire. Cette substance entre dans la fabrication du MOX en tant qu'additif pour la préparation des poudres. La consommation annuelle est de l'ordre de 500kg/an.
La  manipulation est effectuée en zone contrôlée, sous hotte ventilée et avec le port de gants pour la protection des mains.
Aucun substitut n'a été identifié à ce jour.
La validation d'un substitut prendrait plusieurs années compte tenu de la finalité (combustible nucléaire) de l'usage.

(*) The AZB (diazene-1 ,2-dicarboxylic acid (C, C'-azodicarboxylate (formamide)) is used in the nuclear industry. Between this substance in the manufacture of MOX fuel as an additive for the preparation of powders. Consumption annual is of the order of 500kg/an.
Manipulation is performed in a controlled area, a ventilated hood and wearing gloves to protect hands.
No substitute has been identified to date.
Validating a substitute take several years given purpose (nuclear fuel) usage.	See responses #6, 8

(*) Google translation
	
66	2012/10/18	Other contributor
ADCA Task Force
Belgium	See document attached in section IV.
Title: ADCA Fact Sheet	See responses to comments number 66 of Part I – General comments.

See also responses #1 - 8	
			See also:
Comment 66 attachment (Consolidated comments + ADCA Fact Sheet.zip).zip
CONFIDENTIAL attachment removed		
64	2012/10/18	Company
GRANDECO Wallfashion Group succursale France
France	p.38 7.3.4 Consumer exposure. Most blown wallcoverings are produce by rotary screen printing a combination of solid and foamable PVC plastisols. The foamable plastisols contain ADCA as a blowing agent. In addition a ‘kicker’ additive is normally used. This lowers the temperature of decomposition of ADCA and optimises the foam structure during the fusing of the plasticised PVC. Wallcoverings appeal is not only in design but also colour. The yellow tint of unprocessed foamable wallcovering is caused by ADCA. Processing of blown wallcoverings consists of heating to, typically, 210°C. This is above the decomposition of ADCA (204°C, p.11, Table 2). Furthermore the ADCA decomposition is exothermic (p.41, para 3) and it has been suggested that temperatures of 230°C can be reached by the wallcovering. It is thus considered that there is negligible ADCA left in the wallcovering. This is supported by the colour consistency of wallcoverings subjected to this regime indicating complete decomposition of the yellow ADCA.
p.43 Table 14: Chemical blowing agents and their properties. The industry has during the last 30 years researched alternatives to ADCA. The main motivation has been to discover an alternative without the yellow colour of ADCA which is a disadvantage for a colour sensitive product like wallcoverings. The conclusion, to date, has been that ADCA is best suited to blown wallcovering manufacture.
p.44 and 45 Table 15: Physical blowing agents and their properties. These products are not considered usable in a printing process.
p.47 9.1 Human Health Effect Assessment and 9.2 Risk characterisation – Human Health. The wallcovering industry has been aware for many years of the potential health problems associated with the use of ADCA and submissions by two manufacturers are attached. Many manufacturers use ADCA as a paste dispersed in, usually, plasticiser. This obviates any problem of respiratory sensitisation by inhalation and as PPE (gloves) are required to avoid contact with the paste, sensitisation by skin contact is also avoided. It should be technically possible for all wallcovering manufacturers to employ this method although the industry has not been canvassed and no time scale can be suggested at this time.	See responses #5, 7, 8	
			See also:
Comment 64 attachment (ADCA Wallco Industry Statements.pdf).pdf		
60	2012/10/18	Company
Germany	ADCA is handled in our fabrik for decades unter safety precautions like local exhaust ventilations and personal protective equipment (gloves and dusk masks ). We do not observe increased illnes rates, especially not on asthma cases in work places where ADCA is processed.	See response #6	
59	2012/10/18	Company
S.C TROPAL ROMANIA S.R.L
Romania	Use: Tropal (and Palziv, the Parent company) uses ADCA as a Foaming agent for Cross linked Polyethylene and EVA foam. 
Exposure: please see the data in the confidential section attached, of the tests on workers at the plant.
Alternatives: For a small number of products manufactured at Tropal(low expansion foams), there might be some alternative blowing agents that could be used. They are significantly more expensive (perhaps prohibitively), and with regards to safety issues (exposure to the blowing agent and exposure to the gases produced by them)could be problematic. For Low density foams (below 60 kg/m3), there is NO suitable replacement for ADCA.
Risks: Risks are minimal, if the correct safety apparatus is used and safety garments worn (when necessary). If there is a good ventilation system in the factory, and the workers wear gloves and masks when weighing the powder, there is no reason why any of them should be affected by respiratory disease. As seen in the exposure data ( in the confidential section), no worker has been affected by ADCA at Tropal. 	

See response #8

See response #6	
			CONFIDENTIAL attachment removed		
58	2012/10/18	Company
Trelleborg Industri AB
Sweden	ADAC is recieved as powder in plastic bags that we add to the mixing equipment, reducing the level of exposure to our workers. Thereafter is ADAC bunded in an polymer matrix.	Thank you for information on the situation in your company.	
57	2012/10/18	Company
Germany	Sehr geehrte Damen und Herren,
wir setzen Azodicarbonamid (ADC) seit Ende der 60er Jahre in unserer Produktion als Pulver zur Herstellung von Pasten und Compounds ein. 
Aktuelle Mitarbeiterzahl 6.
Kontaktpersonen ADC insgesamt seit Firmengründung: 15
Seither konnten zu keinem Zeitpunkt irgendwelche Anzeichen von Allergien, Hautausschlägen, Asthma oder andere Berufskrankheiten bei direktem Kontakt mit diesem Produkt verzeichnet werden. Eine regelmäßige Überprüfung der vorgeschriebenen und eingesetzten Schutzausrüstung erfolgt durch die Berufsgenossenschaft RCI. Bei genauer Einhaltung der vorgeschriebenen Schutzmaßnahmen gibt es aus der Praxis kein weiteres begründetes Gefahrenpotential.
Mit freundlichen Grüßen
Ekkard von Müllenheim	See response #6	
56	2012/10/18	Company
The Palziv Group
Israel	Use: Tropal (and Palziv, the Parent company,) uses ADCA as a Foaming agent for Cross linked Polyethylene and EVA foam. 
Exposure: please see the data in the confidential section attached, of tests on workers at the plant. 
Alternatives: For a small number of products manufactured at Tropal (low expansion foams), there might be some alternative blowing agents that could be used. They are significantly more expensive (perhaps prohibitively), and with regards to safety issues (exposure to the blowing agent and exposure to the gases produced by them) could be problematic. For Low density foams (below 60kg/m3), there is NO suitable replacement for ADCA.
Risks: Risks are minimal, if the correct safety apparatus is used and safety garments worn (when necessary). If there is a good ventilation system in the factory, and the workers wear gloves and masks when weighing the powder, there is no reason why any of them should be affected by respiratory disease. As seen in the exposure data (in the confidential section), no worker has been affected by ADCA at Tropal.	Repeats comment number 59	
			CONFIDENTIAL attachment removed		
55	2012/10/18	Company
Germany	Because of respiratory sensitization, we conducted in 2004 dust measurements.
The values refer to an addition time of 10 to 15 minutes per batch and four batches a day.
Here, a short-time measurement, (15 minutes) is performed only for the filling of ADCA.
This showed the following results summary test report TÜV Hannover
Both long-term measurement, as well as the short-term measurement during the fill of  ADCA, shows that the measurements are  far below the limits (limit total dust: 10 mg/m³, limit respirable dust:3 mg/m³). The specified DNEL is compliant any way, too (DNEL: 10.58 mg/m³). 
According to the state of art (e. G. exhaust technology) the compliance with the DNEL is guaranteed and in addition the employees wear dust masks when handling ADCA.
Especially regulary medical checks are being provided for these workers. 
By a appropriate communication of safety use over the extended safety data sheet by the manufacturer of ADCA is in our view a classification of ADCA as Substance of very high concern not relevant.

	Thank you for information on the situation in your company. We would like to bring to your attention that the referred DNEL of 10.58mg/m³ is based on systemic effects of ADCA and not on the sensitizing property of ADCA. For the sensitizing property no threshold can be derived, therefore no DNEL can be calculated. Measured concentrations of ADCA below the cited systemic DNEL are not necessarily low enough to protect workers to become sensitized to ADCA.

It is also noted that the attached confidential document demonstrates that the measured fine particle concentration of ADCA is above the limit value set by UK on the basis of the technical feasibility.
See also response #6	
			CONFIDENTIAL attachment removed		
54	2012/10/18	Industry or trade association
UNIONPLAST - Federazione Gomma Plastica
Italy	In addition to this, following a survey that has been conducted among European companies importing and using ADCA, risks from ADCA use is generally adequately addressed, since it is mostly used in a granulate or dispersion in a liquid form, in which case no exposure to the fine powder is expected.
When used in a powder form, a number of risk management measures are commonly used, such as closed systems installed, or in the case of open or semi‐open systems, personal protective equipment such as gloves, goggles and masks, local exhaust ventilation.
Another point to be taken into account is that in the recent decades there has been a fall to almost zero in the number of workers developing asthma due to a suspected exposure to ADCA. All Downstream Users involved in the survey conduct regular medical checks proving this.
As about potential alternatives that have been tested, these resulted not to be appropriate for a complete substitution of ADCA due to inferior quality of foamed products and a negative health and environmental impact of the final products.	See responses #5, 6

See response #8	
53	2012/10/18	Industry or trade association
SNCP/UCAPLAST
France	-	l'azodicarbonamide est utilisé comme agent gonflant pour le caoutchouc cellulaire. Cette substance est indispensable pour plusieurs applications qui servent aussi bien à l'industrie automobile (joints de carroserie) qu'à l'industrie aérospatiale (isolation anti-bruit) mais aussi à la confection de matelas.

-	Compte tenu des caractéristiques intrinsèques de ce produit ( seuil de décomposition élevé, rendement gazeux et coût ) et de la haute technicité mise en œuvre pour la  confection de des  articles, sa substitution n'est aujourd'hui pas techniquement et économiquement envisageable. 
- Les principaux fournisseurs d'ADC, ainsi que nos principaux concurrents étant asiatiques, l'introduction de cette substance sur la liste candidate fragiliserait considérablement la position des utilisateurs en aval européens

(*) azodicarbonamide is used as blowing agent for the foam rubber. This substance is essential for many applications serving both the automotive industry (seals bodywork) to the aerospace industry (noise insulation) but also in the manufacture of mattresses.

- Given the inherent characteristics of the product (threshold decomposition high gas yield and cost) and the high technical implementation for the manufacture of articles, the substitution is not currently technically and economically feasible.
- The main suppliers of ADC and our main competitors are Asian, the introduction of this substance on the candidate list considerably weaken the position of the European downstream users	See responses #8, 9

(*) Google translation

	
			See also:
Comment 53 attachment (2012.10.18 REACH_SNCP_UCAPLAST.pdf).pdf		
48	2012/10/17	Company
L'Isolante K-Flex srl
Italy	In relationship to our experience on rubber and plastic foam, many potential alternatives has been tested, but no one was found to be appropriate for a complete substitution of ADCA due to worse quality of foamed product and negative effect on workers health, risk and environmental impact.	See response #8	
			CONFIDENTIAL attachment removed		
45	2012/10/17	Company
France	7.3.4: Consumer exposure
-	The high degree of decomposition reaction (well above 90 % according to reference 1) in combination with a low quantity of ADCA used to manufacture the final products (see confidential attachment) confirm  the conclusion of the Environment Agency Austria that the exposure is expected to be very low.
In addition, no information is given in the report under which form ADCA will be in contact with the consumers. It is highly unlikely that the consumer is directly in contact with ADCA in powder shape (2-10 micron range as specified in the report) when he uses the final product (for example, in the case of PVC floor coverings ADCA is embedded in the polymer matrix).

       	 1.   OECD: SIDS INITIAL ASSESSMENT PROFILE: Azodicarbonamide : CAS 123-77-3. SIAM 12, 27-29 June
2001; http://webnet.oecd.org/HPV/UI/SIDS_Details.aspx?Key=8d456b9c-328a-44c1-abbd-
0c2cb28d9f5c&idx=0,

8.1: Chemical blowing agents alternatives
As specified by the Austrian experts (see conclusion 8.3) themselves some of these alternatives have serious classifications concerning human health and environment. In some case no information is available for a classification. 
We can note that :
-	OBSH is classified as Carc 1.B, Mut 2 and has among others the hazard statements H317 (may cause an allergic skin reaction) and H334 (may cause allergy or asthma breathering difficulties if inhaled).
-	THS is classified Acute toxicity 3, Mut 2 and has the hazard statement H319 (serious eye damages/ eye irritation) and H315 (causes skin irritation).
-	Phenyltetrazole has the following hazard statements: H 315 (causes skin irritation), H332 (harmful if inhaled) and H335 (may cause respiratory track irritation). We can note that they are no experimental data available on carcinogenicity, mutagenicity, reproductive and developmental toxicity for this chemical.

Toluenesulfonyl semicarbazide and Sodium bicarbonate cannot be used for PVC application (decomposition temperature out of process temperature).

 8.2: Physical blowing agent alternatives
	 The quality of the foam is inferior to those developed with ADCA when Oxygen, Nitrogen and Carbon Dioxide are used. Others proposed alternatives are classified as Flam. liquid 1 or carc. 2 and are therefore not suitable with the manufacturing process (hazards for the workers) and can induce very bad behaviour on the fire resistance of the final products (hazard for the consumers).

8.3:   In conclusion, today there is no alternative to ADCA for manufacturing foamed PVC backing in floor coverings application. A decrease of the acoustical properties of these floor coverings is expected.	See response #7

The OECD document has been used as source of information (see references in the Annex XV dossier)

See response #8
	
			CONFIDENTIAL attachment removed		
43	2012/10/17	Company
Trocellen GmbH
Germany	p.23, para 2: The mentioned particle size is quite small, for foam production the particle size is in the 20 micron range.

P34, para 1: Although manual handling of ADCA at Trocellen factory is minimised all operators being in contact with ADC wear PPE (Dust masks : type FFP2 NR, gloves : rubber, CAT I, eye-protecting lenses : GSF 166 DIN 0196 CE). A yearly repeated training of the workers for safe use of ADCA is reported. Skin contact should be dramatically reduced by these PPE.
P37, para 4: Slovak  reported weighted average exposures of 2 to 5 mg/m3, work place measurements at Trocellen shows results of < 0,04 mg/m3 ( see Staub_BG2008.pdf’, page 3 to 8, Staub_IPT2005.pdf’, ‘ Staub_IWL1991.pdf’). This shows that the working conditions of the year 1981 and 2012 are not comparable.
P38, para 5: No-found of ADCA at 10 large processing plants by HSE in the year 2010. This indicates a safe way of handling ADCA in industrial use. 
P38, para 7: Irritation, sensitisation and cytotoxicity tests have been performed with Trocellen foam products. No negative impact has been detected ( see confidential  report ‘10993_irritation measurements Trocellen_1.pdf’, ).

P43, table 14: The proposed exothermic alternative blowing agents are all classified as acute toxic level 3 to 4, therefore these substances are not a safe alternative for ADCA. The endothermic blowing agents are widely tested as an alternative for ADCA but their low decomposition temperature and the low gas formation made them not useful for the production of crosslinked polyethylene foam, e.g. for insulation material.
P44, table 15: No physical blowing agent can be used in the three step production process for crosslinked polyethylene foam.
P46, para 2: According to the actual technology and the above mentioned risk evaluations none of the mentioned chemical substitutes is an alternative for ADCA.
p.48, para 4: According to the workers health monitoring of the work doctor of Trocellen signs of no respiratory disease affected by ADCA was detected in the last years (data 1987 till today). (see confidentional report ‘Treibmittel Atemwegserkrankungen 2012.pdf’)	The particle size of 2-10µm is cited in Kim, 2004. 

See response #6

The skin irritation test provided in the attachment does not provide any information on the sensitizing property of ADCA.

See response #8

See response #6

	
			CONFIDENTIAL attachment removed		
38	2012/10/17	Individual
France	Forbo Flooring is a manufacturer of floor coverings.
The Reims plant is mainly dedicated to acoustic products and ADCA is used in the foam layer of  these acoustic products from more than 30 years and no health problems have been recorded. 
Workers get medical test every year and lung functioning every 2 years (lung X rays are proposed on case by case basis).

Workers could be exposed to ADCA, in a powder form, only during the feeding of the mixing unit. To feed the mixing unit by aspiration, they use personal protective equipments (Gloves (MAPA Ultranitril 491), masks (half mask type FFP2) and apron). 
One worker per shift is concerned during about 15 mn.
The safety procedure is visible on the equipment and notable items are: empty the plastic bag without waving it, dispose of the plastic bag through a specific route, clean the work area with a broom or atex vacuum cleaner
All the following steps are done in aspirated, closed and automated systems.

After blending, ADCA is included in a plastisol paste and fed behind the coating knife. At this stage, workers aren’t directly exposed to ADCA in a powder form. They only supervise the coater at a distance of 1 meter. They can be in contact with plastisol only in case of intervention. In this case, they wear protective equipments.

Finally, the coated products goes into an oven (where fumes are extracted and treated by an oxydizer) and ADCA is decomposed. 

Chemical blowing alternatives which have been tested (endothermic blowing agents) gave poor results in terms of gas yield, final density and cell size distribution. Nor required final thickness, nor final acoustic properties were achieved.
The final chemical blowing agent we intend to test is OBSH. Its price is about three times the cost of ADCA. The interchange between the materials would not be easily anticipated and a change in current formulation/processing would be expected.	See response #6

See responses #8, 9

41	2012/10/17	Company
Germany	Seit nunmehr 15-20 Jahren arbeiten wir mit ADC (CAS 123-77-3)und in dieser ZeEit sind uns keinerlei Fälle bekannt das durch den Umgang mit ADC irgendwelche Berufskrankheiten aufgetreten sind. Auch sind uns keinerlei Fälle bekannt das durch den Umgang mit diesm Stoff Allergien oder Asthmafälle ausgelöst bzw. aufgetreten sind. Dies gilt für den Personenkreis der den Stoff verarbeitet sowie auch für den gesamten Kundenkreis welche das Endprodukt verarbeiten.	See response #6	
46	2012/10/17	Company
Sekisui Alveo AG
Switzerland	a)	p. 40 ssq. - 8.1 Chemical blowing agents:
Sekisui Alveo produces crosslinked polyolefin foams by using ADCA and by using a sodium bicarbonate/citric acid mixture alternatively as foaming agent. The latter is only applied for special foams intended to come into contact with food.
In our production the thermal foaming process is crucial for the generation of high-quality crosslinked polyolefin foams. This requires a fast decomposition and high gas yield of the applied foaming agent at given temperatures which depend on the process window of the raw materials. At lower temperatures polyolefins are not fluid and cannot be blown. At higher temperatures the foam is damaged due to burning of the surface and collapsing of the foam cells (melt).
Azodicarbonamid is currently the only chemical blowing agent which combines fast thermal decomposition at temperatures suitable for foaming of polyethylene and polypropylene and a high gas yield for the generation of very thin foams with low densities (<100 kg/m3) showing a narrow density distribution in addition.
Sodium bicarbonate/citric acid mixture has a suitable process window for the generation of polyethylene foams. But its decomposition temperature is too low for a controllable blowing of polypropylene with our process. The obtained cell size is comparable to azodicarbonamide-foamed products but the generation of polyethylene foam with densities below 100 kg/m3 is not possible due to inappropriate gas yield.
The foaming agent p,p'-oxybisbenzenesulfonylhydrazide (OBSH) has a lower gas yield compared to ADCA. Thus a higher load of OBSH is required for the generation of foams with low densities. Additionally our trials showed that the actual decomposition temperature in combination with a lower process speed (to ensure complete decomposition) leads to damage of the foam products - burning of the foam surface (darkening). Application of higher speeds to avoid these damages leads to blowing agent rests of about 85 % in the final product which contributes negatively to undesirable emissions (e.g. exceeds VOC limits in the automotive industry).
p-Toluenesulfonylsemicarbazid (TSSC) seems to be an appropriate alternative to ADCA concerning the temperature range of thermal decomposition. However the application of this agent discovers two disadvantages: the low overall gas yield, in particular the lower amount of generated nitrogen (10 - 20 % lower compared to ADCA), and the comparably high content of generated ammonia (about 3 %) which diffuses slowly out of the foam.
In the case of 5-phenlytetrazole foaming polyolefin is also possible due to a sufficient decomposition temperature and medium, but acceptable, gas yield. Furthermore, nitrogen is the major gas component formed. Unfortunately our tests showed that 5-phenytetrazole melts significantly prior to decomposition at the recommended temperature. The melted blowing agent leads to property changes of the crude product which results in uncontrollable or even impossible foaming process. A considerably higher temperature has to be applied to decompose the foaming agent faster in the oven.  As a negative result severe damage of the foam product occurs (burning of the surface). The risk of ignition and burning of the polyolefin during the foaming process is enhanced. Actually this happened during tests with our lab equipment.
Toluenesulfonylhydrazide (TSH) has not been taken into account as suitable alternative chemical blowing agent by our development department due to the low decomposition temperature which disables the foaming even of polyethylene (not fluid).
Taking in consideration our experience with alternative blowing agents listed in the dossier it has to be concluded that none of these alternatives is as efficient as ADCA for the production of crosslinked polyolefin foams. The alternative substances might have advantages in other fields of foaming agent application, but in the field of high-performance crosslinked polyolefin foams they cannot replace ADCA.
b)	p.44 ssq. - Physical blowing agents:
Sekisui Alveo also produces non-crosslinked foams by using isobutene or carbon dioxide in our production plant in Germany. These foam products are produced by direct extrusion foaming which differs from the process applied to generate high-quality crosslinked polyolefin foams (see also Chapter V, Confidential Attachement 2, pages 35 - 36). Non-crosslinked foams in general do not exhibit identical advantageous physical and chemical properties compared to crosslinked polyolefin foams (see also comments on 'p. 33 - 7.2.3e Other articles and mixtures containing ADCA', above). 
Direct extrusion foaming with carbon dioxide results in cell sizes which are comparable to those of crosslinked foams. But the density which can be obtained by this process is limited to >250 kg/m3.
Isobutane-foamed materials show bigger cell sizes, which leads to reduced thermal insulation. In addition the foam exhibits unfavourable thickness distribution (waves).
Thus it can be concluded that physical blowing agents are suitable for the production of non-crosslinked foams. But they are not feasible as foaming agent in the production of high-performance crosslinked polyolefin foams.	See response #8
See also responses to comments number 46 in Part I.	
			See also:
Comment 46 attachment (Attachment to Comments - Chapter IV.pdf).pdf
Confidential attachment submitted		
47	2012/10/17	Company
Belgium	2.	For our application there are limited blowing agents suitable. ADCA is the only option with the least impact on health and environment.
3.	Our application is not covered by the Annex XV dossier. 
4.	The exposure of the workers of the company to ADCA during all steps of the production process is low. No cases of sensitizing effects are occurred. 
5.	There is limited evidence that final products contain residues of ADCA and even more these residues can cause health effects. As a consequence ADCA will not be widespread. 	See response #8

See response #6

See response #7	
			See also:
Comment 47 attachment (20121008 ADCA public version.docx).docx
Confidential attachment submitted		
37	2012/10/17	Company
Hungary	page 43 table 14
The list of chemical blowing agent alternatives is containing chemicals which are far more dangerous than ADCA. 
From the alternatives we already tested OBSH, which we couldn’t use properly in our technology. OBSH is decomposing at lower temperature than ADCA. The expansion with OBSH was too quick, was hard to control.
Our foam needs to expand in three steps. It is expanding half way in our first stage press. After that it has to expand also in our second stage press. Further to that it has to expand third time by our customers doing thermoforming.
OBSH decomposed by our trials in one step. In our second stage presses and by our thermoforming customers it didn’t expand at all.
As noted earlier the Austrian proposal itself shows OBSH as more dangerous (mutagen, carcinogen) than ADCA.
The endothermic blowing agents are better from health point of view, but they are also absolutely useless in our technology. Here we also made several trials. Endothermic blowing agents are developing watersteam by the decomposition and because of that fact the foam is shrinking after the process. The shrinkage is not some percentage but rather about 50%. This is unacceptable by a product like ours.	See response #8	
			CONFIDENTIAL attachment removed		
36	2012/10/17	Industry or trade association
Germany	p.38 7.3.4 Consumer exposure. Most blown wallcoverings are produce by rotary screen printing a combination of solid and foamable PVC plastisols. The foamable plastisols contain ADCA as a blowing agent. In addition a ‘kicker’ additive is normally used. This lowers the temperature of decomposition of ADCA and optimises the foam structure during the fusing of the plasticised PVC. Wallcoverings appeal is not only in design but also colour. The yellow tint of unprocessed foamable wallcovering is caused by ADCA. Processing of blown wallcoverings consists of heating to, typically, 210°C. This is above the decomposition of ADCA (204°C, p.11, Table 2). Furthermore the ADCA decomposition is exothermic (p.41, para 3) and it has been suggested that temperatures of 230°C can be reached by the wallcovering. It is thus considered that there is negligible ADCA left in the wallcovering. This is supported by the colour consistency of wallcoverings subjected to this regime indicating complete decomposition of the yellow ADCA.
p.43 Table 14: Chemical blowing agents and their properties. The industry has during the last 30 years researched alternatives to ADCA. The main motivation has been to discover an alternative without the yellow colour of ADCA which is a disadvantage for a colour sensitive product like wallcoverings. The conclusion, to date, has been that ADCA is best suited to blown wallcovering manufacture.
p.44 and 45 Table 15: Physical blowing agents and their properties. These products are not considered usable in a printing process.
p.47 9.1 Human Health Effect Assessment and 9.2 Risk characterisation – Human Health. The wallcovering industry has been aware for many years of the potential health problems associated with the use of ADCA and submissions by two manufacturers are attached. Many manufacturers use ADCA as a paste dispersed in, usually, plasticiser. This obviates any problem of respiratory sensitisation by inhalation and as PPE (gloves) are required to avoid contact with the paste, sensitisation by skin contact is also avoided. It should be technically possible for all wallcovering manufacturers to employ this method although the industry has not been canvassed and no time scale can be suggested at this time.	Repeats comment number 64 of Part II	
			See also:
Comment 36 attachment (ADCA Wallco Industry Statements.pdf).pdf		
34	2012/10/17	Individual
Italy	p.38 7.3.4 Consumer exposure. Most blown wallcoverings are produce by rotary screen printing a combination of solid and foamable PVC plastisols. The foamable plastisols contain ADCA as a blowing agent. In addition a ‘kicker’ additive is normally used. This lowers the temperature of decomposition of ADCA and optimises the foam structure during the fusing of the plasticised PVC. Wallcoverings appeal is not only in design but also colour. The yellow tint of unprocessed foamable wallcovering is caused by ADCA. Processing of blown wallcoverings consists of heating to, typically, 210°C. This is above the decomposition of ADCA (204°C, p.11, Table 2). Furthermore the ADCA decomposition is exothermic (p.41, para 3) and it has been suggested that temperatures of 230°C can be reached by the wallcovering. It is thus considered that there is negligible ADCA left in the wallcovering. This is supported by the colour consistency of wallcoverings subjected to this regime indicating complete decomposition of the yellow ADCA.
p.43 Table 14: Chemical blowing agents and their properties. The industry has during the last 30 years researched alternatives to ADCA. The main motivation has been to discover an alternative without the yellow colour of ADCA which is a disadvantage for a colour sensitive product like wallcoverings. The conclusion, to date, has been that ADCA is best suited to blown wallcovering manufacture.
p.44 and 45 Table 15: Physical blowing agents and their properties. These products are not considered usable in a printing process.
p.47 9.1 Human Health Effect Assessment and 9.2 Risk characterisation – Human Health. The wallcovering industry has been aware for many years of the potential health problems associated with the use of ADCA and submissions by two manufacturers are attached. Many manufacturers use ADCA as a paste dispersed in, usually, plasticiser. This obviates any problem of respiratory sensitisation by inhalation and as PPE (gloves) are required to avoid contact with the paste, sensitisation by skin contact is also avoided. It should be technically possible for all wallcovering manufacturers to employ this method although the industry has not been canvassed and no time scale can be suggested at this time.	Repeats comment number 64 of Part II.	
			See also:
Comment 34 attachment (ADCA.pdf).pdf		
32	2012/10/17	Member State
United Kingdom	The dossier identifies use as a nebulising agent in a biocidal room fogging product containing cyphenothrin as its active ingredient. The unreacted product contains 10-25% ADCA. Thermal degradation of ADCA enables the biocidal fog to be generated. The retailer of this product claims that any unreacted ADCA is retained in the container. This use was not included in registration data but is subject to approval under Directive 98/8/EC (The Biocidal Products Directive), to be replaced by Regulation (EU) 528/2012 from 1 Sept 2013. 

Comment on the information submitted in the confidential annex. Page 60 – to help interpret the measured exposure data (8-hr TWA), it would be useful to have more details about the processes that are in operation, the controls that are being applied and whether they are deemed to be effective as applied at this workplace.	Thank you for this clarification.

This information was provided via questionnaire by one registrant only indicating that ADCA was managed as a powder. Further information on details about the process was not provided.	
31	2012/10/17	Individual
Italy	•	Over the recent decades there has been a fall to almost zero in the number of workers developing asthma due to a suspected exposure to ADCA; all DUs conduct regular medical checks proving that	See response #6	
			See also:
Comment 31 attachment (ECHA.doc).doc		
30	2012/10/17	Industry or trade association
Germany	For our comments on alternative blowing agents point 8 (page 40 ff) austrian dossier please read document attached.

It describes the disadvantages of the existing 4 alternatives. Potential alternatives have been tested. Result: There exist no approriate alternative, which is able to substitute ADCA in the endapplications of our members PVC foam (floor covering, coating of a textile to produce synthetic leather, yogamat, tableprotection, bath and showermats antislip).Alternatives have inferior quality  and/or negative health and environmental impact of the final products.

Risk characterisation – Human Health point 9.2, page 47 ff

no consumer exposure to ADCA, no release from final product

Worker exposure without risks,
zero workers developing asthma due to a suspected exposure to ADCA

Reasons:

ADCA is either used in a granulate or dispersion in a liquid form, in which case no exposure to the fine powder is expected.
Isisonly rarely used in a powder form. In this rare cases it is mainly uses in a closed system. If it is used an open or semi-open system, personal protective equipment such as gloves, goggles and masks are used in the production steps  In case of manual discharge of bags or mixinga local exhaust ventilation is always installed.

In the US ADCA is explicitly allowed as food additives : Code of Federal Regulations, Title 21, Chapter I, Section 172.806, it is also allowed as blowing agent for PA and PVC Section 177.2600/178.3010.	See response #8

See responses #5, 6

We are aware that ADCA is used as food additive outside the EU but it is not permitted as a flour treatment agent in the EU. (see also chapter 7.2.1 of the Annex XV Dossier)	
			See also:
Comment 30 attachment (Summary Examination Results of Alternative  Blowing Agents.docx).docx		
29	2012/10/16	Company
Germany	p.38 7.3.4 Consumer exposure. Most blown wallcoverings are produce by rotary screen printing a combination of solid and foamable PVC plastisols. The foamable plastisols contain ADCA as a blowing agent. In addition a ‘kicker’ additive is normally used. This lowers the temperature of decomposition of ADCA and optimises the foam structure during the fusing of the plasticised PVC. Wallcoverings appeal is not only in design but also colour. The yellow tint of unprocessed foamable wallcovering is caused by ADCA. Processing of blown wallcoverings consists of heating to, typically, 210°C. This is above the decomposition of ADCA (204°C, p.11, Table 2). Furthermore the ADCA decomposition is exothermic (p.41, para 3) and it has been suggested that temperatures of 230°C can be reached by the wallcovering. It is thus considered that there is negligible ADCA left in the wallcovering. This is supported by the colour consistency of wallcoverings subjected to this regime indicating complete decomposition of the yellow ADCA.
p.43 Table 14: Chemical blowing agents and their properties. The industry has during the last 30 years researched alternatives to ADCA. The main motivation has been to discover an alternative without the yellow colour of ADCA which is a disadvantage for a colour sensitive product like wallcoverings. The conclusion, to date, has been that ADCA is best suited to blown wallcovering manufacture.
p.44 and 45 Table 15: Physical blowing agents and their properties. These products are not considered usable in a printing process.
p.47 9.1 Human Health Effect Assessment and 9.2 Risk characterisation – Human Health. The wallcovering industry has been aware for many years of the potential health problems associated with the use of ADCA and submissions by two manufacturers are attached. Many manufacturers use ADCA as a paste dispersed in, usually, plasticiser. This obviates any problem of respiratory sensitisation by inhalation and as PPE (gloves) are required to avoid contact with the paste, sensitisation by skin contact is also avoided. It should be technically possible for all wallcovering manufacturers to employ this method although the industry has not been canvassed and no time scale can be suggested at this time.	Repeats comment number 64 of part II	
28	2012/10/16	Industry or trade association
Fédération de la Plasturgie
France	1-	Selon les contacts que nous avons eus avec les fournisseurs / importateurs d’azodicarbonamide (ADCA) réunis au sein d’un consortium, le dossier Annexe XV des autorités autrichiennes n’apporte aucune preuve d’un niveau de préoccupation équivalente permettant d’appuyer leur demande d’inscription de l’ADCA à la Liste Candidate de REACH.

2- Suite à une enquête que notre fédération a menée auprès de ses adhérents, il ressort que les industriels du secteur de la Plasturgie en France qui mettent en œuvre l’ADCA ont pris des mesures de gestion des risques adéquates permettant de réduire l’exposition des opérateurs :
> L’ADCA est utilisé soit sous forme de granulés (mélanges-maîtres ou compounds), soit sous forme de dispersion liquide ce qui permet d’éviter l’exposition aux poussières d’ADCA sources d’irritation respiratoire.
> Dans les cas où l’ADCA est utilisé sous forme de poudre, soit il est utilisé dans des systèmes fermés évitant tout contact entre les opérateurs et la substance, soit dans des systèmes ouverts ou semi-fermés, et dans ces cas, des équipements de protection individuels sont utilisés (gants, lunettes et masques) en particulier lors des phases de vidange des emballages et de mélangeage, généralement en complément de systèmes de ventilation / aspiration des ateliers.

3- Durant les décennies récentes, on a pu constater une chute jusqu’à presque zéro du nombre d’opérateurs développant de l’asthme du à une exposition à l’ADCA. Les utilisateurs en aval font régulièrement des contrôles prouvant ce constat.

4- Les possibles substituts de l’ADCA ont été testés et aucun n’apportent les mêmes propriétés que l’ADCA en termes de qualité, de propriétés techniques et d’impacts sanitaires et environnementaux des produits finis.

Fort de ces éléments, nous considérons que la demande des autorités autrichienne n’est pas justifiée.

(*) 1 - According to the contacts we have had with the suppliers / importers of azodicarbonamide (ADCA) together in a consortium, the Annex XV dossier Austrian authorities provides no evidence of an equivalent level of concern to of support their application for registration of the ADCA REACH Candidate List.

2 - Following an investigation that led our federation among its members, it appears that the industrial sector of the plastics industry in France that implement DCAA took measures appropriate risk management to reduce exposure operators:
> The ADCA is used either in the form of granules (masterbatches or compounds), either as a liquid dispersion which prevents the dust exposure sources ADCA respiratory irritation.
> In cases where DCAA is used in powder form, or it is used in closed systems avoiding contact between operators and the substance or in open systems or semi-closed, and in these cases, equipment personal protection are used (gloves, goggles and masks) especially when filling or emptying containers and mixing, usually in addition to ventilation / exhaustion at the workshops.

3 - During recent decades, there has been a drop to almost zero the number of operators developing asthma due to exposure to DCAA. Downstream users regularly checks proving this fact.

4 - Possible substitutes DCAA were tested and none provide the same properties as the ADCA in terms of quality, technical properties and health and environmental impacts of finished products.

With these elements, we consider that the Austrian authorities' request is not justified.	

(*) google translation

See response #1

See responses #5, 6

See response #8
	
27	2012/10/16	Industry or trade association
Belgium	p37-38 (National Records): the data reported are extremely variable but for most of them conclude an exposure below the detection limit or below the limit set by the UK HSE. A generalistion based on such weak evidences cannot be scientifically supported and is totally irrealistic even from a statistical point of view.

p3!-39 (Consumer exposure): the levels of ADCA identified in articles are all extremely low (well below the 0.1% or even 0.001%), which is perfectly understandable as ADCA inherently decomposes at elevated temperature. It can thus only be present as impurity in the final articles. There is no information reported on the potential release of ADCA from these articles which is the important data that could support a potential exposure of the consumer. It is however well known that additives embedded in a plastic matrix do not migrate out of it and do not show any 'bioavailability' that could be the cause of adverse effects on the human health. 
p38 (Consumer Exposure): The conclusion extracted from this chapter is clear and confirm our statements: "These data show that exposure of consumers to ADCA cannot be excluded even though it is expected to be very low (Environment Agency Austria, 2012a)". It is amazing to see that no evidence is presented to support the likely of a "very low" exposure... This clearly means that such data do not exist and that in fact no evidence exists to support an consumer exposure.
p42-42: Alternatives: this chapter is a simple list of existing blowing agents (physical and chemical). Clearly most of them are not suited to replace ADCA which enjoys a very wide range of uses due to the possibility to regulate its effects in function of the plastic used and of the efffect desired. Such possibilities of fine tuning are not possible with all the alternatives listed and cannot thus replace ADCA. It is also important to remember that the use of ADCA as a blowing agent allows to produce lightweight plastics articles and thus allows the plastics industry to save significant volumes of raw material, contributing so to the sustainability of our planet.	In the Annex XV dossier all publicly available data was considered. Confidential information on present exposure concentrations is given was the confidential annex to the dossier.

See responses #6, 7

See response #8	
26	2012/10/16	Industry or trade association
European Council of Vinyl Manufacturers
Belgium	General aspects, page 23: The statement “It is manufactured predominantly as a yellow/orange powder with a particle size in the 2-10 micron range” is outdated. ADCA is mainly used nowadays either as granulate or dispersion in a liquid form. 

General aspects, page 24: “ADCA decomposes into semicarbazide, a suspected carcinogen, when heated”. During normal use ADCA decomposes with liberation of gas (CO2, CO and N2) leaving urea as by-product which remains in the plastic.  The information on page 35 is more balanced.

Information on alternatives (pages 40 – 45): Potential alternatives have been tested and neither turned out to be appropriate for a complete substitution of ADCA due to inferior quality of foamed products and a negative health and environmental impact of the final products. The usefulness of ADCA is that, in combination with accelerators  its decomposition temperature can be lowered so as to coincide with the normal PVC melt viscosity, thus producing a controlled, even foam	The particle size is cited from Kim, 2004 

This paragraph is a citation from EFSA, 2005, where only the decomposition into semicarbazide was investigated. Detailed information on decomposition of ADCA is given in chapter 7.3.2 of the Annex XV dossier.

See response #8	
25	2012/10/16	Company
United Kingdom	p.38 7.3.4 Consumer exposure. Most blown wallcoverings are produce by rotary screen printing a combination of solid and foamable  PVC plastisols. The foamable plastisols contain ADCA as a blowing agent. In addition a ‘kicker’ additive is normally used. This lowers the temperature of decomposition of ADCA and optimises the foam structure during the fusing of the plasticised PVC. Wallcoverings appeal is not only in design but also colour. The yellow tint of unprocessed foamable wallcovering is caused by ADCA.  Processing of blown wallcoverings consists of heating to, typically, 210°C. This is above the decomposition of ADCA (204°C, p.11, Table 2). Furthermore the ADCA decomposition is exothermic (p.41, para 3) and it has been suggested that temperatures of 230°C can be reached by the wallcovering. It is thus considered that there is negligible ADCA left in the wallcovering. This is supported by the colour consistency of wallcoverings subjected to this regime indicating complete decomposition of the yellow ADCA.  p.43 Table 14: Chemical blowing agents and their properties. The industry has during the last 30 years researched alternatives to ADCA. The main motivation has been to discover an alternative without the yellow colour of ADCA which is a disadvantage for a colour sensitive product like wallcoverings. The conclusion, to date, has been that ADCA is best suited to blown wallcovering manufacture.  p.44 and 45 Table 15: Physical blowing agents and their properties. These products are not considered usable in a printing process.  p.47 9.1 Human Health Effect Assessment and 9.2 Risk characterisation – Human Health. The wallcovering industry has been aware for many years of the potential health problems associated with the use of ADCA and submissions by two manufacturers are attached. Many manufacturers  use ADCA as a paste dispersed in, usually, plasticiser. This obviates any problem of respiratory sensitisation by inhalation and as PPE (gloves) are required to avoid contact with the paste, sensitisation by skin contact is also avoided. It should be technically possible for all wallcovering manufacturers  to employ this method although the industry has not been canvassed  and no time scale can be suggested at this time. 	Repeats comment number 64 of Part II	
			See also:
Comment 25 attachment (ADCA Wallco Industry Statements.pdf).pdf		
23	2012/10/16	Company
Germany	In 2002 mesurements for detection of ADCA were done in several working places:
-in the factory of elastomers by moulding
-in the factory of continuous vulcanisation (microwave units) and ready-made products. Measurement-time was 2 hours. All 4 results were <0,005 mg/m³ ADCA.	See response #6	
			CONFIDENTIAL attachment removed		
21	2012/10/16	Company
BIG floorcoverings NV
Belgium	- we conduct regular medical checks on our workers. People having contact with ADCA are screened specifically. 
- since the start of our operations, no single medical problem was reported on people exposed to ADCE.
- Exposure is limited through the use of adequate personal protective equipment (gas-dust mask, gloves, special clothing), dust extraction systems and the use of the product in liquid phase wherever and whenever possible.
- the alternatives are none: for PVC applications, none of the given alternatives are real alternatives: they are not safe, not practical, haven't got the right window of operation, are not priceworthy, ... 
- the risks described in the dossier are known to the industry and therefore, they are handled adequately.	See response #6

See response #8	
20	2012/10/16	Individual
Belgium	p.38 7.3.4 Consumer exposure. Most blown wallcoverings are produce by rotary screen printing a combination of solid and foamable PVC plastisols. The foamable plastisols contain ADCA as a blowing agent. In addition a ‘kicker’ additive is normally used. This lowers the temperature of decomposition of ADCA and optimises the foam structure during the fusing of the plasticised PVC. Wallcoverings appeal is not only in design but also colour. The yellow tint of unprocessed foamable wallcovering is caused by ADCA. Processing of blown wallcoverings consists of heating to, typically, 210°C. This is above the decomposition of ADCA (204°C, p.11, Table 2). Furthermore the ADCA decomposition is exothermic (p.41, para 3) and it has been suggested that temperatures of 230°C can be reached by the wallcovering. It is thus considered that there is negligible ADCA left in the wallcovering. This is supported by the colour consistency of wallcoverings subjected to this regime indicating complete decomposition of the yellow ADCA.
p.43 Table 14: Chemical blowing agents and their properties. The industry has during the last 30 years researched alternatives to ADCA. The main motivation has been to discover an alternative without the yellow colour of ADCA which is a disadvantage for a colour sensitive product like wallcoverings. The conclusion, to date, has been that ADCA is best suited to blown wallcovering manufacture.
p.44 and 45 Table 15: Physical blowing agents and their properties. These products are not considered usable in a printing process.
p.47 9.1 Human Health Effect Assessment and 9.2 Risk characterisation – Human Health. The wallcovering industry has been aware for many years of the potential health problems associated with the use of ADCA and submissions by two manufacturers are attached. Many manufacturers use ADCA as a paste dispersed in, usually, plasticiser. This obviates any problem of respiratory sensitisation by inhalation and as PPE (gloves) are required to avoid contact with the paste, sensitisation by skin contact is also avoided. It should be technically possible for all wallcovering manufacturers to employ this method although the industry has not been canvassed and no time scale can be suggested at this time.	Repeats comment number 64 of Part II	
			See also:
Comment 20 attachment (ADCA Wallco Industry Statements.pdf).pdf		
16	2012/10/15	Industry or trade association
IGI - The Global Wallcoverings Association
Belgium	p.38 7.3.4 Consumer exposure. Most blown wallcoverings are produce by rotary screen printing a combination of solid and foamable  PVC plastisols. The foamable plastisols contain ADCA as a blowing agent. In addition a ‘kicker’ additive is normally used. This lowers the temperature of decomposition of ADCA and optimises the foam structure during the fusing of the plasticised PVC. Wallcoverings appeal is not only in design but also colour. The yellow tint of unprocessed foamable wallcovering is caused by ADCA.  Processing of blown wallcoverings consists of heating to, typically, 210°C. This is above the decomposition of ADCA (204°C, p.11, Table 2). Furthermore the ADCA decomposition is exothermic (p.41, para 3) and it has been suggested that temperatures of 230°C can be reached by the wallcovering. It is thus considered that there is negligible ADCA left in the wallcovering. This is supported by the colour consistency of wallcoverings subjected to this regime indicating complete decomposition of the yellow ADCA.

p.43 Table 14: Chemical blowing agents and their properties. The industry has during the last 30 years researched alternatives to ADCA. The main motivation has been to discover an alternative without the yellow colour of ADCA which is a disadvantage for a colour sensitive product like wallcoverings. The conclusion, to date, has been that ADCA is best suited to blown wallcovering manufacture.

p.44 and 45 Table 15: Physical blowing agents and their properties. These products are not considered usable in a printing process.

p.47 9.1 Human Health Effect Assessment and 9.2 Risk characterisation – Human Health. The wallcovering industry has been aware for many years of the potential health problems associated with the use of ADCA and submissions by two manufacturers are attached. Many manufacturers  use ADCA as a paste dispersed in, usually, plasticiser. This obviates any problem of respiratory sensitisation by inhalation and as PPE (gloves) are required to avoid contact with the paste, sensitisation by skin contact is also avoided. It should be technically possible for all wallcovering manufacturers  to employ this method although the industry has not been canvassed  and no time scale can be suggested at this time.	Repeats comment number 64 of Part II	
			See also:
Comment 16 attachment (ADCA Wallco Industry Statements.pdf).pdf		
13	2012/10/15	Company
L&L Products
France	Page 23 “INFORMATION ON USE, EXPOSURE, ALTERNATIVES RISK”

USE
Our activity is not fully described in the document, since we provide non expanded parts which will blow at our costumers. The azodicarbonamide decomposes at the costumers plants.
The closest scenario of our activity is “extrusion” where low probability of contact between operator and ADCA is related. In our activity, most of the contact between the operator and ADCA occurs during the weighting step. Apart from that, there is no direct contact in the following steps.

EXPOSURE 
The description on the industries using ADCA shows that there is a wide variety of activities, products and therefore of ADCA concentration. Typical concentration range for L&L activity is less than 5%. This is in the low range of the industry. 
The sensitization process of human people is not very well known. However protection avoids it. When heated, ADCA releases several substances in addition to nitrogen(=blowing gaz). However they are such in a low concentration a final foamed article, that the foamed product is not hazardous.

ALTERNATIVE TO ADCA IN OUR ACTIVITY 
Chemical blowing agent : there is no evident alternative :
-	Process window is different
-	Gaz yield : our applications need high level of gaz yield
-	Many grades available for ADCA, not for allternatives
-	Nitrogen - stable foam structure
-	Cost
-	Iso properties of foamed materials?

Physical blowing agent: difficult to use for our applications:
-	Delivery of a foamed material, which is not our activity,
-	Permeability > nitrogen - collapsing
-	Process change

Conclusion : finding alternative will be long, time consuming and expensive. What is more, most of the alternative technical solutions may be hazardous.

RISK 
Respiratory sensitization through skin sensitization: not proved.
Minimum exposure limit for thresholds not found.
Many activities found to have exposure > 1mg/m3. What about ours? There is very limited exposure of the operator.	

See response #6

See response #6

See response #8

See response #6	
12	2012/10/15	Company
REHAU AG + Co.
Germany	pages 38 to 46:
A PVC foam core pipe is extruded with an inner and an outer layer of not foamed rigid PVC. Even if traces of ADCA would survive processing no consumer will be able to come into contact with these traces due to the coextruded layers.

REHAU is producer of several articles produced of foamed rigid PVC, e.g. foam core pipes and foamed PVC-profiles. Azodicarbonamide is an essential component for the production of these articles and it cannot be substituted by blowing agents like pentane, carbon dioxide, bicarbonates, OBSH, TSSC and so on because of technical reasons. The alternatives mentioned in the annex-XV-dossier of the Austrian competent authority are a misinformation. Perhaps they didn't ask people experienced with the production of PVC foam core pipes or with the production of other foamed PVC profiles.	
See response #7 

See response #8	
11	2012/10/15	Company
LEHVOSS Italia S.r.l.
Italy	•Case studies mentioned in the Annex XV report have been created several decades ago. No data is given on the concentration of ADCA in the breathable air and on which safety equipment had been applied. Therefore, the data from these case studies is non transferable to the current situation of working places in the EU regarding modern safety procedures.

•There is no indication of an increased level of illnesses in our manufacturing process. ADCA is handled for decades under safety precautions like local exhaust ventilations and personal protective equipment (e.g. gloves and dusk masks). We do not observe increased illness rates, especially not on asthma cases in work places where ADCA is processed. 

•ADCA is mostly used as chemical blowing agent for plastics and rubber; during this application ADCA is almost completely decomposed so that in foamed plastics and rubber products or articles for end consumers no relevant ADCA amounts will remain; 

•Evaluation of alternatives: The alternatives mentioned in the Annex XV dossier do not perform for the products we supply to our customers. Based on statements from our customers (who deliver  e.g. products to the automotive industry) foamed products made by using alternatives to ADCA are not processable to final parts. Thus the alternatives are not suitable for most automotive material requirements. 	See response #4

See response #6

See response #7

See response #8
	
10	2012/10/15	Company
LEHVOSS FRANCE Sarl
France	•Case studies mentioned in the Annex XV report have been created several decades ago. No data is given on the concentration of ADCA in the breathable air and on which safety equipment had been applied. Therefore, the data from these case studies is non transferable to the current situation of working places in the EU regarding modern safety procedures.

•There is no indication of an increased level of illnesses in our manufacturing process. ADCA is handled for decades under safety precautions like local exhaust ventilations and personal protective equipment (e.g. gloves and dusk masks). We do not observe increased illness rates, especially not on asthma cases in work places where ADCA is processed. 

•ADCA is mostly used as chemical blowing agent for plastics and rubber; during this application ADCA is almost completely decomposed so that in foamed plastics and rubber products or articles for end consumers no relevant ADCA amounts will remain; 

•Evaluation of alternatives: The alternatives mentioned in the Annex XV dossier do not perform for the products we supply to our customers. Based on statements from our customers (who deliver  e.g. products to the automotive industry) foamed products made by using alternatives to ADCA are not processable to final parts. Thus the alternatives are not suitable for most automotive material requirements. 	Repeats comment number 11 of Part II	
9	2012/10/15	Company
Lehvoss UK Limited
United Kingdom	•Case studies mentioned in the Annex XV report have been created several decades ago. No data is given on the concentration of ADCA in the breathable air and on which safety equipment had been applied. Therefore, the data from these case studies is non transferable to the current situation of working places in the EU regarding modern safety procedures.

•There is no indication of an increased level of illnesses in our manufacturing process. ADCA is handled for decades under safety precautions like local exhaust ventilations and personal protective equipment (e.g. gloves and dusk masks). We do not observe increased illness rates, especially not on asthma cases in work places where ADCA is processed. 

•ADCA is mostly used as chemical blowing agent for plastics and rubber; during this application ADCA is almost completely decomposed so that in foamed plastics and rubber products or articles for end consumers no relevant ADCA amounts will remain; 

•Evaluation of alternatives: The alternatives mentioned in the Annex XV dossier do not perform for the products we supply to our customers. Based on statements from our customers (who deliver  e.g. products to the automotive industry) foamed products made by using alternatives to ADCA are not processable to final parts. Thus the alternatives are not suitable for most automotive material requirements. 	Repeats comment number 11 of Part II	
8	2012/10/12	Company
Continental AG / Beneke Kalicko AG
Germany	3.)Evaluation of the ADCA exposure in our plants and from the final products:
A Production
General Remark: ADCA is received as a powder, as a plasticizer batched material or compounded in a PE or PP matrix. 
First Process Step: Batching ADCA powder to paste
Measurements of short time exposure show a dust concentration of 0.60 mg/m³ and an alveolar dust concentration of 0.67 mg/m³ in the area of the working places where ADCA is handled as a powder.  These values are far below the German limits of 10 mg/m³ for dust and 3 mg/m³ for alveolar dust.  Furthermore we are far below the limit of 3 mg/m³ for ADCA short time exposure as given by United Kingdom regulations. 
As to further minimize the amount of incorporated dust we have local exhaust ventilations in place and the operators carry gloves and dusk mask as personal protective equipment.
Further Process Steps: Mixing, coating, extrusion
In further process steps only ADCA plasticizer pastes or ADCA polymer blends are handled. Therefore there is no contamination of the breathable air by ADCA and thus no exposure to workers.
B Final Product
In the step of foam generation ADCA is decomposed and does in principle not remain in the product. In addition, exposure to end consumers by our automotive car interior products, consisting of PVC foam foils (unsupported expanded vinyl), coated textiles (“artificial leather”, supported expanded vinyl), TPO foam foils can be excluded because ADCA is only added to one out of several layers of the product to generate a foam during the foaming process step in order to make the material soft and light weight according to the automotive customers’ specifications. As this foam layer forms the middle layer of the product which is covered by solid layers of material from both sides no ADCA can be exposed. 
4.)Concerning this item we have included a renowned German university toxicologist and are in an ongoing discussion with him.  He stated clearly that the health risk of ADCA is far below the one of CMR substances, especially because the ADCA exposure risk is only observable in the field of professional workers. Here the exposure can be controlled by technical installations and personal protective equipment for the workers.
5.)	Evaluation of alternatives:
The alternatives mentioned in the dossier do not perform for the products we produce. Automotive interior PVC and TPO foam foils made with ACDA alternatives are not processable to final parts (as proven by internal studies and a 2012 Master thesis at the University of Reutlingen). For coated textiles only specific products can be made with less mechanical stability. Thus the alternatives are not suitable for most automotive material requirements.	
See response #6

See response #5

See response #7

See response #6

See response #8

18	2012/10/09	Company
Lehmann & Voss & Co. KG
Germany	•Case studies mentioned in the Annex XV report have been created several decades ago. No data is given on the concentration of ADCA in the breathable air and on which safety equipment had been applied. Therefore, the data from these case studies is non transferable to the current situation of working places in the EU regarding modern safety procedures.

•There is no indication of an increased level of illnesses in our manufacturing process. ADCA is handled for decades under safety precautions like local exhaust ventilations and personal protective equipment (e.g. gloves and dusk masks). We do not observe increased illness rates, especially not on asthma cases in work places where ADCA is processed. 

•Measurements of short time exposure in our plants (from 2012) show a dust concentration of 0.27 mg/m³ in the area of the working places where ADCA is handled as a powder. These values are far below the German limits of 10 mg/m³ for dust (and 3 mg/m³ for alveolar dust). Furthermore we are far below the limit of 3 mg/m³ for ADCA short time exposure as given by United Kingdom regulations. As to further minimize the amount of dust particles we have installed local exhaust ventilations and all operators carry gloves and dusk mask as personal protective equipment. 

•We supply ADCA mostly as a batched material (masterbatch) in which the substance is homogenously embedded into a polymeric matrix; during intended use no ADCA is released from the masterbatches as free substance; this has been proved by tests performed by an independent laboratory.

•ADCA is mostly used as chemical blowing agent for plastics and rubber; during this application ADCA is almost completely decomposed so that in foamed plastics and rubber products or articles for end consumers no relevant ADCA amounts will remain; 

•Evaluation of alternatives: The alternatives mentioned in the Annex XV dossier do not perform for the products we supply to our customers. Based on statements from our customers (who deliver  e.g. products to the automotive industry) foamed products made by using alternatives to ADCA are not processable to final parts. Thus the alternatives are not suitable for most automotive material requirements. 	Repeats comment number 11 of Part II	
17	2012/10/09	Company
Lanxess Limited
United Kingdom	Pages 23-40, Chapter 7: Information on manufacture, import/ export, and uses - conclusions on exposure:

Formulation of ADCA mixtures: 
ADCA is not produced within the European Community. Imported ADCA is formulated in Europe. Formulation means that the pure substance is mixed with additives which adapt the decomposition characteristics of ADCA to the needs of the commercial processors or which alter the supply form. Typical industrial processes are powder mixing, co-micronisation, dispersing in liquid carriers, two roll processing, and extrusion. The supply forms are powder, low dust powder, liquid (paste) and dust-free solids (granules). The end users of these supply forms is the commercial industry.

Processing and decomposition: 
The ADCA or its ADCA formulation is incorporated in a polymer matrix. The obtained compound is processed such that the ADCA decomposes and gas is generated which forms bubbles respectively a foam structure in the polymer matrix. Typical end user application are foam core pipes, foamed PVC sheets, foamed wall and floor coverings, foamed rubber, thermoinsulation foams. 

During processing ADCA is decomposed exothermic to a degree of >99,9% as mentioned in the Annex XV Dossier 7.3.4 Consumer Exposure submitted by: Environment Agency Austria published at 03/09/2012. Possibly remaining ADCA and its non-gaseous decomposition products are embedded in the polymer matrix and are not available as powdery product raising concerns.

Exposure of powdery ADCA: 
Possibly minimal amounts of remaining ADCA after processing and decomposition are embedded in the polymer matrix. Therefore ADCA in its powder form, which may raise concerns, is handled only by the industry in defined areas. LANXESS Limited delivers only ADCA formulations to industrial users, the consumer use of powdery ADCA is excluded. This allows to take effective measures against ADCA exposure to worker, e.g. exhausting, personal protection. When these measures are ensured by handling standards we are of the opinion that the safe use of ADCA is ensured and its handling will not have serious social consequences for workers and an inclusion on the candidate list is rendered unnecessary.	See responses #5, 6

See response #7	
5	2012/10/07	Company
Zebra-chem GmbH
Germany	To 2 QUALIFIED INDUSTRIAL JOBS
The quantity used and processed of Azodicarbonamide in Germany is several thousand tons per annum and more then 10.000 tons in the EU. There is a highly specialized market of companies in the European Union which are producing and exporting Azodicarbonamid preparations and products made with Azodicarbonamide all over the world. The number of employees related to this market can not exactly be estimated in the short time of 45 days available to write a comment. It is estimated in the range of several thousand industrial full time jobs. There is a high level of added value which is due to know how build over long time. This know how and the taxes as a result of this know how would disappear into other parts of the world as there is no intention in Asia nor in the Americas to stop the use of Azodicarbonamide. 

To 3 APPLICATIONS AND RECYCLING INDUSTRIE OF PLASTIC
There are many applications where Azodicarbonamide is used in the EU. The biggest by volume are:
-high temperature isolation
-foaming of pipes
-foaming sheets 
-foaming cables
Especially the second on, foaming of pipes has created over the last 10 years a big market of recycling applications. This marked depend heavily on the use of Azodicarbonamide. The strongly increasing use of recycled, with Azodicarbonamid foamed polymers like PVC in the last 10 years has created a very high acceptance of this polymer in the general public. In addition the high level of recycling has lead to dropping prices in the pipe and profile industry and to a very elegant way of re-using PVC products like window frames, pipes and building profiles which can have a second live cycle. This polymers will be around for much longer. As an additional advantage this has pushed a machine industry of machines suitable for recycling. In this industry the EU based producers are world leaders.   
   
To 4 CURRENT KNOWLEGDE OF ALTERNATIVES:
This is the weakest point of the dossier and it shows in a very apparent way that the composer of the dossier is not at all related to the specific know how of the use and the processing of Azodicarbonamide. Unfortunately it even seems that there was little interest to become acquainted to the details of the matter. This might be related to the fact that there is no market for Azodicarbonamid in Austria and therefore there is nothing to loose. 
The replacement of Azodicarbonamid in the manufacturing of foamed articles with alternative foaming agents listed in Chapter 8 has not lead to any real positive result in the industry which where commercially successful. The statement at the end of chapter 8.3 Conclusion “Other alternatives such as the use of physical blowing agents (e.g. nitrogen, supercritical carbon dioxide, pentane) have been developed and used with success particularly for extrusion and pressure moulding process” is just wrong. This statement applies for a marginal part of some very specific processes and some polymers but such alternatives are not suitable for commercial applications like sewage pipes, foam sheets and high temperature insulation.

Conclusion: 
It is unreasonable to put Azodicarbonamide on the list of SVHC for the following reason. If we compare the cases of numbers of workers which got asthma and where the asthma can be surly related to the contact with Azodicarbonamide the number of cases is very low. It must be kept in mind that most workers who have had contact with Azodicarbonamide have also contact with many other dusty materials which can lead to the same problems. The problem of causing asthma or asthma symptoms to people is known, even in a very small percentage to products like saw dust, flower, calcium carbonate and other bulk chemicals in powder form. 

Therefore we recommend removing Azodicarbonamide from the list of SVHC. The proposal is unreasonable if you compare the advantages to the disadvantages.

Georg Gundacker							 
MD Zebra-chem GmbH, Germany
7.Oktober 2012	
See response #9

See responses #6, 9

See response #8	
			See also:
Comment 5 attachment (050920 - Prüfbericht Azodicarbonamid-Mikrogranulat-staubfreiheit.pdf).pdf		
3	2012/10/01	Company
United Kingdom	Current handling – 
ADC as respiratory sensitizer is well documented. Details of this fact are clearly listed in safety documentation and also in descriptive text found on raw material packaging.
The industry, through highly important responsible care procedure combined with safe practice and general common sense have taken measures to control use within the work environment and minimise risk to any employee handling such materials. Factors implemented to minimise risk which are commonly found in an industrial environment may include – 
Specific training of safe practice, associated material risk and the correct adoption of personal protective equipment (PPE). 
Training will include notification to employees as to the nature of this material and any associated risks together with common sense safe practice – for example keeping material in sealed containers when not in use, minimising any direct handling, minimising risk of dust formation and spillage through responsible general handling.  
PPE issued to employees handling this material will include suitable face screens, dust masks, overalls, gloves, goggles and general work wear.  
Responsible sites ensure adequate dust extraction and ventilation and in many cases separate rooms or buildings are adopted to minimise exposure to the general workforce.
Employees are informed that when handling this material, they must not smoke, eat or drink and that general good house-keeping and personal cleanliness (i.e. washing of hands after use etc.) must be adopted.   
In many cases the material is supplied to secondary users e.g. Compounders or formulators in one of the following formats –
Diluted systems where the additive is blended with low risk, inert chemistry for example polymer to minimise dust and concentrated exposure.
Diluted systems are often handled in bulk format from sealed packaging and subsequent handling example weighing, conveying and mixing are handled through automatic feed systems with near zero employee exposure. 
The additive may be supplied in pre-weighed, sealed sachets which may be added direct to a compounding mixer with no exposure to dust from the handling operatives.
The additive may be supplied in a solid masterbatch format. Often found as a pellet or granule, the material is agglomerated or encapsulated into low to zero dust handling formats. Such materials are commonly found across a range polymer applications (plastics and rubber).
The additive may be supplied in a damped format, essentially creating a heavy powder which settles rapidly rather than forming a potential dust cloud.
The additive may be supplied in a dust free liquid dispersion which allows clean handling and zero risk of airborne dust.
In addition the industry and our company in particular, is forever seeking further technical enhancement of this and other chemicals and highly concentrated, zero dust, fine particle, encapsulated additive is being developed for industrial scale usage.
Irrespective of the handling options provided to the industry, secondary users of the product adopt a responsible approach to their employees and the above options combined with suitable training and PPE severely limits risk of exposure in companies across Europe. 
Technical Alternatives -
With regards to the listed technical alternatives, the following needs great consideration.
Firstly it must be asked, why are many polymers foamed and why is ADC used as an additive to create foamed structures in polymers?
The foaming of polymer structures is not new. The creation of cellular structures in polymers via the incorporation of ADC has been highly established and provides numerous technical, commercial, decorative, safety and environmental gains over non-foamed products. For example benefits of foamed articles include – 
•	Reduced weight for a given volume = ease of handling, transportation, reduced emissions during transport, improved fuel efficiency in transport applications.
•	Increased volume for a given weight = greater structural rigidity, reduced levels of polymer consumption (and effectively oil, energy, emissions).
•	Decorative options in design = three dimensional structure without increased material usage.
•	Increased cushioning = impact absorption, cushioning, comfort, personal safety.
•	Increased thermal insulation = reduced energy loss, reduced energy consumption, reduced emissions. 
•	Increased sound insulation = reduced noise pollution, improved personal safety.
•	Increased buoyancy = improved safety in aquatic environments.
To reduce the options of foaming would incur secondary damage to the environment and send current technology in insulation and fuel preservation back by several years or more. 
ADC a material used to create a cellular structure in polymers has a highly proven technological track record in industry. The material, either directly or when modified depending on process and polymer type, allows accurate control of cell structure and density across a broad range of process method, polymeric material and application use. It should be considered that for many years, companies have trialled potential alternatives but have in many many cases failed to achieve the same or indeed similar technical performance when so called alternatives have been evaluated irrespective of cost.
The views regarding the ‘alternative’ technologies are as follows – from document page 41.
OBSH and TSH-these materials decompose at temperatures below the suitable processing of many polymers. Their use is restricted to low temperature applications and this would prevent use in the processing of many applications. Whilst it is listed as being used in rubber foams, in many cases OBSH or TSH are not suitable candidates and ADC is widely adopted by the rubber industry based upon its technical merit. It is also listed as being suitable for use in PVC plastisols however this area is limited predominately to wallcoverings and more specifically wallcoverings requiring a coarse, high level of expansion to create a three dimensional patterned structure. In many wallcoverings this is too dramatic an effect and the more controllable levels found from modified ADC is preferred. In other PVC plastisol application areas such as flooring and synthetic leather, modified ADC is the preferred choice as the decomposition of OBSH or TSH would be too severe and limit the control of foaming thus negatively impacting upon cushioning and thermal insulation as well as decorative structure. It is correct OBSH is used in LDPE wire insulation however this sector is a minor fraction of LDPE and Polyolefin consumption where foaming agents are used. For injection moulding sectors endothermic systems are already established however in cross linked PE, PP or EVA applications the decomposition point of OBSH/TSH is far too low and suitable cell structures cannot be achieved. This has been trialled extensively on an industrial scale without success and the use of ADC dominates this field. OBSH is found in selected areas of increased process temperature including uPVC however here they are used solely as a partial portion of the foaming system, the key exothermic technology being modified ADC where small levels of OBSH are included to help reduce decomposition point and improve whiteness in the final product. In rubber TSH may also be used as a partial foaming agent, again combined with ADC.
TSSC – A semicarbazide based foaming agent which is used in high temperature applications but has found limited volume use in Europe due to the small process window and low levels of gas yield. It is used in some non-European markets as a co-foaming agent combined with ADC but is not, as possibly inferred, widely used in PP within the EU. It should also be noted that whilst the document in other sections refers to the negative aspect of semicarbazide being a decomposition residue of ADC (albeit in extremely low levels), that a semicarbazide based foaming agent is listed as an alternative chemistry for use.
5PT – Another high temperature foaming agent which has found limited use in the European market as compared to ADC it is more difficult to control at reduced process temperatures.
Sodium Bicarbonate/Modified Sodium Bicarbonates – An example where ADC is not used purely on commercial grounds. SBC is a low cost foaming agent compared to ADC yet its use as a singular foaming agent is limited due to the low decomposition point, rate of gas release and more importantly gas type which is principally carbon dioxide as opposed to nitrogen. If SBC was a technical alternative, the low cost of this technology would have swept ADC away many decades ago and whilst it is used in selected areas it cannot be used successfully everywhere, even when modified as listed in the document. The endothermic nature and low cost chemistry has found favour in areas such as polyolefin injection moulding and as a co-foaming agent (with ADC) in uPVC extrusion. It should be noted that in uPVC extrusion for example profile or sheet extrusion, the use of endothermic technology alone is not possible as the chemistry creates a relatively coarse cell structure or insufficient levels of foaming to reach technical requirements. The nitrogen formation from the ADC helps nucleate the gases formed and it is highly proven across Europe that a combination system is required. Highly modified forms of SBC are also established in the PET sheet process for example food packaging but again it cannot be used across all polymer applications. The reason is the gas released and the rapid rate of diffusion compared to nitrogen. Due to the diffusion of this gas it cannot be used in low pressure processing for example – PVC plastisols for flooring/wallcovering/synthetic leather, rotational moulding, cross linked Polyolefin manufacture, high temperature processing or without significant modification in moisture sensitive polymers (eg PET, Nylon) as water is a secondary product of decomposition.
From the above list of chemical alternatives, it is agreed that in selected cases they are used and are used on their own technical merits, however they must not under any circumstance be considered a possible alternative across all areas.
Even if they could be considered a technical option, other factors such as the basic lack of global supply capacity to meet demand in replacing ADC and the environmental or commercial implication of change must be factored in to any reasoning.  In many cases, processors have historically trialled such technologies to ascertain if a technical or commercial advantage can be achieved over ADC. In many cases they have failed and a change in process technology may never be possible irrespective of technical approach.
Physical Foaming Agents Gas Injection – On page 46, the final paragraph in the conclusions, lists physical foaming agents as having success particularly in extrusion and high pressure moulding processes. It is good to hear that this is accepted as being unsuitable for low pressure expansion applications however it must also be considered that it has found limited use in extrusion. The technology is not new and has itself been offered for many years. There is no question that where operating the performance levels are high, however it must also be considered that this is not used across extrusion as a whole as in many cases it is unsuitable in industrial practice. Should this be incorrect, the question on using ADC would not even arise as it would have covered all areas of the market already but this has not been the case in reality.

As further comment to the document, there is question regarding the relevance of understanding in some of the statements regarding consumer exposure (page 38). The key reason for citing ADC is due to the issue of being a respiratory sensitizer yet section 7.3.4 questions the levels of unreacted ADC in end articles. With regards to exposure from unreacted ADC, when processed within a polymer, the ingredient is effectively encapsulated rather than remaining as free dust and as such would be considered extremely rare to cause an issue through inhalation to the respiratory tract. The potential for semicarbazide to remain as a product of decomposition is possible however this was investigated thoroughly in 2003/2004 by EFSA and a decision was made to ban its use in food contact articles only as these areas relate to direct food contact. As listed in the document ADC is however still used as a direct food ingredient, albeit at controlled levels, outside of the EU. Irrespective of food, any European restriction in use of ADC as a foaming agent in polymers would be impossible to police regarding foamed articles manufactured outside of the EU but imported in to it.
As the vast majority of applications using ADC as a foaming agent are based within construction and insulation sectors, or areas where there is little direct contact and almost zero chance of ingestion, it could be considered that the risk to the consumer from semicarbazide or ADC powder inhalation is extremely low if even applicable.
To summarise, whilst it is agreed ADC is a respiratory sensitizer, the industry has taken a responsible approach to the safe handling of this material and avenues have been taken to minimise exposure via a number of directions dependent upon risk and working environment.
Other foaming systems as potential alternatives to ADC are listed but their success is only proven in a limited number of areas despite broad industry evaluation over many years.	See responses #5, 6

See responses #8, 9

See response #7.

The formation of semicarbazide has not been taken into account when assessing the equivalent level of concern of ADCA.
	
2	2012/09/19	Company
United Kingdom	Pages 8 - 19
Concerning the justification that ADCA exposure to workers and potentially to consumers is likely to occur under normal conditions of use; this is very unlikely.  
Within the supply chain there are several steps that the substance will undergo before it reaches the final article and eventually the consumer.
In the initial stages of manufacture and processing, industrial good working practices, safety equipment, COSHH assessments, dust extraction in the location of use and industrial exposure monitoring, will be in place to protect the exposed worker.
Manufacturing of paste dispersions for use in further product compound is additionally undertaken.  These pastes consist of solids dispersed within a plasticiser or other liquid carrier.  This is an activity that our company undertakes to produce a product that is supplied to several markets, such as wallcovering, flooring and siding manufacture.  These paste dispersions are liquid in form and as such the hazard of the product being dusty by nature is removed for further handling.  Almost all industrial manufacturers of plastic articles that are foamed using this chemical blowing agent use these paste dispersions or other polymer bound master batches.  These products are not hazardous to health via inhalation.
Further use and downstream products are also considered to be safe in this respect because the dusty nature of the chemical no longer exists. Therefore the claimed exposure potential to consumers and most workers is actually not a risk that is present.
Further processing of this chemical in paste or solid master batch form, via a thermoplastic product undergoing heating and shaping, results in the full decomposition of this chemical, producing gas.  It is this exothermic decomposition which forms the basis of selection of this chemical for foaming of thermoplastic articles.  When the articles are placed on the market, this chemical is fully decomposed and cannot present a risk via an inhalation route.
Therefore, the substance cannot and should not be identified as SVHC based on REACH Article 57f under an equivalent level of concern to CMR substances, because this dusty hazard is in most cases not actually present, except in very tightly controlled industrial uses, where the general public are not placed under any risk or exposed.	Repeats comment number 2 of Part I	

Attachments

Comment number	Public attachment	
5	
Comment 5 attachment (050920 - Prüfbericht Azodicarbonamid-Mikrogranulat-staubfreiheit.pdf).pdf	
16	
Comment 16 attachment (ADCA Wallco Industry Statements.pdf).pdf	
20	
Comment 20 attachment (ADCA Wallco Industry Statements.pdf).pdf	
25	
Comment 25 attachment (ADCA Wallco Industry Statements.pdf).pdf	
30	
Comment 30 attachment (Summary Examination Results of Alternative  Blowing Agents.docx).docx	
31	
Comment 31 attachment (ECHA.doc).doc	
34	
Comment 34 attachment (ADCA.pdf).pdf	
36	
Comment 36 attachment (ADCA Wallco Industry Statements.pdf).pdf	
42	
Comment 42 attachment (letter Maltoni English.pdf).pdf	
44	
Comment 44 attachment (FREMAP_PDF013.pdf).pdf	
46	
Comment 46 attachment (Attachment to Comments - Chapter IV.pdf).pdf	
47	
Comment 47 attachment (20121008 ADCA public version.docx).docx	
49	
Comment 49 attachment (Title VII. with footnotes.doc).doc	
53	
Comment 53 attachment (2012.10.18 REACH_SNCP_UCAPLAST.pdf).pdf	
62	
Comment 62 attachment (20017_2012_Echa_54 SVHC consultation.pdf).pdf	
64	
Comment 64 attachment (ADCA Wallco Industry Statements.pdf).pdf	
66	
Comment 66 attachment (Consolidated comments + ADCA Fact Sheet.zip).zip	
67	
Comment 67 attachment (Endutex Comments on ANNEX XV proposal to include ADCA as SVHC substance.pdf).pdf	
71	
Comment 71 attachment (1210 GERFLOR ADCA ECHA.doc).doc