19 November 2011

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

Substance name:	pyrochlore, antimony lead yellow	
CAS number:	8012-00-8	
EC number:	232-382-1	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Repr. 1A

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.

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	
8	2012/10/18	International NGO
Health and Environment Alliance
Belgium	We support the adoption of this chemical to the Candidate List.	Thank you for providing your opinion.	
7	2012/10/18	Member State
Norway	It is recognised globally that lead and its compounds pose a significant risk to human health and the environment and that there remains a need for a continued focus on reducing the risks posed by these substances. The concerns for lead compounds are their reprotoxic/neurotoxic properties. The Committee for Risk Assessment under REACH has stated that no threshold for the adverse effect of lead has been identified in humans.  We would also like to stress that the long lasting harmful effects to the environment are of serious concern (cf. classification of lead compounds in general and a number of specific lead compounds in CLP concerning environmental hazard;  "Aquatic Acute 1" ("Very toxic to aquatic life") and  "Aquatic Chronic 1" ("Very toxic to aquatic life with long lasting effects"). 

The Norwegian CA supports that pyrochlore, antimony lead yellow should be identified as a substance of very high concern and should be included in the Candidate List.
	Thank you for providing your opinion.	
6	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 Pyrochlore, antimony lead yellow 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 providing your opinion.	
5	2012/10/17	Industry or trade association
Inorganic Pigments Consortium
Spain	The Inorganic Pigments Consortium is the organization that manages the REACH and CLP obligations of companies that manufacture / import inorganic pigments in the EU. The Consortium currently includes 25 members from different European countries, mainly Spain, Italy, Germany and UK. The members of the Consortium are the largest producers in Europe for this substance.

The Inorganic Pigments Consortium considers that substance pyrochlore, antimony lead yellow should not be considered for prioritisation for authorisation due to the low tonnage volume manufactured.

Only three companies registered this substance in 2010. The total tonnages per year of pigment manufactured from these companies are:

Data in tons/year of 
manufactured pigment	2009	2010	2011	2012
TOTAL	                35.2	36.1	21.1	13.8

Important note: this communication was submitted on 16/10/2012. However we have not received any confirmation e-mail from ECHA, for this reason we submit our comments again.	Thank you for your comment and the information provided. 

Please refer to response to comment #5 in the section “specific comments on use, exposure, alternatives and risks”. 

4	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 providing your opinion.	
3	2012/10/16	Industry or trade association
Inorganic Pigments Consortium
Spain	The inorganic pigments consortium considers that due to the low tonnage volumes manufactured for this substance (less than 15 tons/year in 2012) this substance should not be considered for prioritisation for authorisation.

Only three companies registered this substance in 2010. The total tonnages per year of pigment manufactured from these companies are:

Data in tons/year of 
manufactured pigment	2009	2010	2011	2012 
(estimates)
TOTAL           	35.2	36.1	21.1	13.8

	Same comment as #5.  
	
2	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 providing your opinion.	
1	2012/10/11	Member State
Germany	We appreciate ECHA´s efforts to compile SVHC-Dossiers on such short notice. We do not fully understand the selection criteria, which are different to the approach taken by the MS for SVHC-identification.
Even though these substances can easily be put on the candidate list due to their CMR-classification, careful assessment of the relevance (tonnage, wide-spread use, exposure, prevention of substitution by equally hazardous substances) should be carried out for justification of the SVHC-identification. The RMO analysis is a crucial step in the process not only to share and discuss risk management options with MS but also to provide a justification for such far reaching measures.

Without further information on potential risks that may be related to any other uses of this substance, the reason to identify this substance as SVHC remains unclear.
Therefore, we would suggest that thorough RMO analyses are prepared and shared with MSCAs as soon as possible.	Thank you for your comment. 

In accordance with REACH Article 59 only the Member States and the Commission have the right to propose substances for identification as substances of very high concern (SVHC) meeting the criteria of Article 57. 
ECHA has received a request from the Commission to prepare an Annex XV dossier proposing the identification of this substance as SVHC, which was followed by the Agency. 

Preparation of a risk management options analysis (RMOA) before proposing the identification of a substance as SVHC is a voluntary step in the co-ordination of risk management activities among the Competent Authorities for REACH but not a requirement of REACH. 
Nevertheless, ECHA agrees on the importance of identifying the most appropriate route(s) for risk management and on the co-operation and co-ordination of the regulatory risk management activities between the authorities.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
1	2012/10/11	Member State
Germany	No information about the physical properties is given in the report or in the technical dossier. In the report a link to the Chemical Substance Search on the ECHA website is given instead. It would be better to provide these data directly in the report (and the technical dossier), so that no further search in a database is necessary.	SVHC is based on its harmonised classification in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation). The physical properties of the substance are in this particular case neither necessary to define the identity of the substance addressed in the dossier nor to demonstrate that it meets criteria set out in Article 57. 

If however information on the physical properties would be required to describe the substance identity or to conclude on its SVHC properties those data should be included in the Annex XV dossier.

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	
5	2012/10/17	Industry or trade association
Inorganic Pigments Consortium
Spain	Description of uses

The main use of substance pyrochlore, antimony lead yellow (EC 232-382-1) is industrial use in decorative ceramics. Customers are typically decal printers who buy ceramic colors and media to produce printing pastes by their own. This inorganic pigment can be used by direct inclusion in a vehicle which allows for its application by serigraphy on the ceramic substrate. Firing temperature is 800-900 ºC. It can also be mixed in order to prepare glazes, which are then applied on the ceramic support with different techniques; in this case temperature can be up to 1100 ºC. In all the applications, the pigment remains after firing integrated and protected by the glaze in the ceramic article. It is standard practice in this industry to use exhaustion, protective glasses and safety gloves during the weighing and pasting process as recommended in the safety data sheets.

Specific names given by industry for uses and applications are: Decal printing, coloured glazes, direct printing bone china, on glaze banding for bone china, glass wall tiles.

Volumes

Only three companies registered this substance in 2010. The total tonnages per year of pigment manufactured from these companies are:

Data in tons/year of 
manufactured pigment	2009	2010	2011	2012 
(estimates)
TOTAL	                35.2	36.1	21.1	13.8

Regulatory efficiency

Technical rules for handling of hazardous materials are in force which applies to the handling of lead compounds. Some examples are TRGS-402/ 403 in Germany, IEC 436 Type A and BS6748:1986 (equivalent DIN 51031:1986) in UK. Engineering and ventilation controls, cleaning, personal protective equipment and personal hygiene are all measures to control dispersion of lead compounds towards the workers. The use of the personal protective equipment (PPE) (and respiratory protection plus local exhaust ventilation when handling heavy metal containing containig material) is observed.
For blood lead data, a monitoring regime is in place that covers all site activities (for women and for men). Certified laboratories are used to measure blood lead levels. All respective workers are submitted to blood lead monitoring, which includes increased monitoring frequency for workers undertaking high-risk jobs and workers with elevated blood lead levels. 
All workers have a blood test prior to working on site. The blood lead levels of workers are typically monitored every two years, in reference to an “action level” that is 15 µg/dL for men deemed to be safe. If the action level is exceeded, appropriate measures are to be taken, (e.g. ban overtime, provide counseling on proper work practice and hygiene, instigate an individual blood lead management plan, increase blood lead sampling frequency) in an effort to prevent further increases in blood lead. If the safe threshold (40 g/dL for men; 10 g/dL for women) is exceeded, continue ban on overtime, ensure strict hygiene procedures are followed, undertake detailed inspections to ensure correct use of personal protective equipment, undertake detailed inspections to ensure recommended workplace procedures are followed, move employee to workplace where exposure is expected to be lower or remove from lead environment altogether, further increase blood lead sampling frequency, and continue frequent sampling until results are below the first action level. 

Releases

Pyrochlore is an inorganic pigment which is the product of a calcination reaction involving lead and antimony oxides. Facilities are equipped with scrubbers and filters, so no significant emission of heavy metals into the environment is expected. For German sites, the emission of lead in production is controlled every 3 years according to the German legislation for control of emissions (BImSchG). Lead emissions to air are reported in the range of 0.3-0.4 mg/m3, whereas lead emissions to water are reported in the range 0.02-0.04 mg/L. These values are well below the limit values established in National regulations.

Measurements on blood lead levels for workers are included in the CSR of the registration dossier for pyrochlore, antimony lead yellow. 90th percentile of the information provided is 19.2 g/dL lead in blood.

Possible alternatives

Pyrochlore pigments are the standard pigments for on-glaze and container glass decoration. The following possible alternatives of yellow pigments could be evaluated:
a) Organic pigments: not stable at the conditions necessary for ceramic applications.
b) Zr-Pr-Si yellow or Zr-V yellow: these pigment type are very weak and therefore not suitable for on-glaze and glass colors).
c) Nickel or chrome titanates (Ni-Sb-Ti or Cr-Sb-Ti): these pigments have in opposite to pyrochlore pigments a very high opacity which is negative for 4-color process applications.
d) Cadmium sulphide are not considered a serious alternative due to the use of cadmium.

A comparison was made between an on-glaze yellow decoration color based on a Pb-Sb pigment with a Ni-Sb-Ti. Using Ni-Sb-Ti pigment the yellow color is less intensive than with a Pb-Sb pigment. This loss in intensity ranges between 2 and 4 Lab-units (CIE Lab color space). Much more impact has the difference in opacity. Here the difference is 20 Lab-units. Titanates are much more opaque, which is a significant disadvantage especially in the 4-color process. A nickel or chrome titanate yellow printed on top of a cyan color will not give an acceptable green. Accordingly no green decorations can be achieved in this important technology.
If pyrochlore yellows would not be available in future all decal printers would have to change their formulations of those mixing colors, which contain this pigment type due to the different mixing behavior caused by the very different opacity. In the end, a part of the colour space covered with pyrochlore, antimony lead yellow would remain uncovered.
	Thank you for the information provided. 

The current proposal only concerns identifying the substance as a substance of very high concern (SVHC) in accordance with REACH Article 59(2). If the substance is identified as SVHC, information in relation to controls under other legislation, use, exposure, alternatives and risks will be taken account of at other stages in the authorisation process.

Even though information provided during public consultation is taken into account, we would like to stress that the registrations are the standard tool and route to communicate information on a substance and its uses to the authorities The registrations are the authorities’ principal source of information when assessing the need of further risk management for a substance or (some of) its uses. Therefore, it is of utmost importance that registrants keep the information provided in the registration dossiers up to date and adequately describing the current use and exposure situation, including the operational conditions and risk management measures in place.
If certain uses are not covered by the provided exposure scenarios, downstream users can either communicate this through supply chain communication (via their suppliers) to the registrants, who then need to update their registrations accordingly, or prepare their specific chemical safety report and submit a downstream user report to ECHA.

Topics such as the availability and suitability of alternatives, socio-economic considerations regarding the benefits of a use or the (adverse) impacts of ceasing a use as well as information on the low level of risk associated to a use are important. Information regarding these topics should be provided as part of the application for authorisation (e.g. in the analysis of alternatives, the chemical safety report or the socio-economic analysis). This information will be taken into account by the Risk Assessment and Socio-Economic Analysis Committees when forming their opinions and by the Commission when taking the final decision. It may impact the decision on granting the applied for authorisation and the conditions applicable to the authorisation, such as e.g. the length of the time limited review period of the authorisation.

	
3	2012/10/16	Industry or trade association
Inorganic Pigments Consortium
Spain	Description of uses

The main use of substance pyrochlore, antimony lead yellow (EC 232-382-1) is industrial use in decorative ceramics. Customers are typically decal printers who buy ceramic colors and media to produce printing pastes by their own. This inorganic pigment can be used by direct inclusion in a vehicle which allows for its application by serigraphy on the ceramic substrate. Firing temperature is 800-900 ºC. It can also be mixed in order to prepare glazes, which are then applied on the ceramic support with different techniques; in this case temperature can be up to 1100 ºC. In all the applications, the pigment remains after firing integrated and protected by the glaze in the ceramic article. It is standard practice in this industry to use exhaustion, protective glasses and safety gloves during the weighing and pasting process as recommended in the safety data sheets.

Specific names given by industry for uses and applications are: Decal printing, coloured glazes, direct printing bone china, on glaze banding for bone china, glass wall tiles.

Volumes

Only three companies registered this substance in 2010. The total tonnages per year of pigment manufactured from these companies are:

Data in tons/year of 
manufactured pigment	2009	2010	2011	2012 
(estimates)
TOTAL	                35.2	36.1	21.1	13.8

Regulatory efficiency

Technical rules for handling of hazardous materials are in force which applies to the handling of lead compounds. Some examples are TRGS-402/ 403 in Germany, IEC 436 Type A and BS6748:1986 (equivalent DIN 51031:1986) in UK. Engineering and ventilation controls, cleaning, personal protective equipment and personal hygiene are all measures to control dispersion of lead compounds towards the workers. The use of the personal protective equipment (PPE) (and respiratory protection plus local exhaust ventilation when handling heavy metal containing containig material) is observed.
For blood lead data, a monitoring regime is in place that covers all site activities (for women and for men). Certified laboratories are used to measure blood lead levels. All respective workers are submitted to blood lead monitoring, which includes increased monitoring frequency for workers undertaking high-risk jobs and workers with elevated blood lead levels. 
All workers have a blood test prior to working on site. The blood lead levels of workers are typically monitored every two years, in reference to an “action level” that is 15 µg/dL for men deemed to be safe. If the action level is exceeded, appropriate measures are to be taken, (e.g. ban overtime, provide counseling on proper work practice and hygiene, instigate an individual blood lead management plan, increase blood lead sampling frequency) in an effort to prevent further increases in blood lead. If the safe threshold (40 g/dL for men; 10 g/dL for women) is exceeded, continue ban on overtime, ensure strict hygiene procedures are followed, undertake detailed inspections to ensure correct use of personal protective equipment, undertake detailed inspections to ensure recommended workplace procedures are followed, move employee to workplace where exposure is expected to be lower or remove from lead environment altogether, further increase blood lead sampling frequency, and continue frequent sampling until results are below the first action level. 

Releases

Pyrochlore is an inorganic pigment which is the product of a calcination reaction involving lead and antimony oxides. Facilities are equipped with scrubbers and filters, so no significant emission of heavy metals into the environment is expected. For German sites, the emission of lead in production is controlled every 3 years according to the German legislation for control of emissions (BImSchG). Lead emissions to air are reported in the range of 0.3-0.4 mg/m3, whereas lead emissions to water are reported in the range 0.02-0.04 mg/L. These values are well below the limit values established in National regulations.

Measurements on blood lead levels for workers are included in the CSR of the registration dossier for pyrochlore, antimony lead yellow. 90th percentile of the information provided is 19.2 g/dL lead in blood.

Possible alternatives

Pyrochlore pigments are the standard pigments for on-glaze and container glass decoration. The following possible alternatives of yellow pigments could be evaluated:
a) Organic pigments: not stable at the conditions necessary for ceramic applications.
b) Zr-Pr-Si yellow or Zr-V yellow: these pigment type are very weak and therefore not suitable for on-glaze and glass colors).
c) Nickel or chrome titanates (Ni-Sb-Ti or Cr-Sb-Ti): these pigments have in opposite to pyrochlore pigments a very high opacity which is negative for 4-color process applications.
d) Cadmium sulphide are not considered a serious alternative due to the use of cadmium.

A comparison was made between an on-glaze yellow decoration color based on a Pb-Sb pigment with a Ni-Sb-Ti. Using Ni-Sb-Ti pigment the yellow color is less intensive than with a Pb-Sb pigment. This loss in intensity ranges between 2 and 4 Lab-units (CIE Lab color space). Much more impact has the difference in opacity. Here the difference is 20 Lab-units. Titanates are much more opaque, which is a significant disadvantage especially in the 4-color process. A nickel or chrome titanate yellow printed on top of a cyan color will not give an acceptable green. Accordingly no green decorations can be achieved in this important technology.
If pyrochlore yellows would not be available in future all decal printers would have to change their formulations of those mixing colors, which contain this pigment type due to the different mixing behavior caused by the very different opacity. In the end, a part of the colour space covered with pyrochlore, antimony lead yellow would remain uncovered.
	Same comment as #5.