Comments on public consultation 0003-02

Summary

The following comments have been submitted to date as part of the public consultation on alternatives for Applications for authorisation. ECHA accepts no responsibility or liability with regard to the information (including attachments) presented below.

For details on the public consultation process, please refer to Applications for Authorisation.

 

Substance name
Bis(2-ethylhexyl) phthalate (DEHP)
EC Number
204-211-0
CAS Number
117-81-7
Entry Nr in Annex XIV
4
Broad information on use applied for (title)
Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)]
Consultation number
0003-02
Applicant name(s)
Grupa Azoty Zakłady Azotowe Kędzierzyn Spółka Akcyjna
Consultation period
13/11/2013 - 08/01/2014


Comments

# Submitter Alternative Attachments
Type Generic name EC Number CAS Number Description of technology Classification and Labelling
16
Affiliation: company

Type/ Role in supply chain: Downstream User

Name of org/company: confidential

Country: confidential
Substance (on its own) DOTP229-176-96422-86-2No classification according to Regulation 1272/2008/EC necessary. No classification and labelling according to Directive 67/548/eeg or Directive 1999/45/EC necessary. Download
19
Affiliation: organisation

Type/ Role in supply chain: Non-governmental organisation (NGO)

Name of org/company: ChemSec

Country: Sweden
Other A wide range of companies have phased out DEHP in their products and production- accordingly a wide range of alternatives are available, chemical alternatives, alternative plastic materials or other technical solutions. Download
26
Affiliation: individual

Type/ Role in supply chain:

Name of org/company:

Country: Japan
Other anuary 6, 2014 Opinion of JPIA on Information on Use Applied for in Application for Authorisation(DEHP) Japan Plasticizer Industry Association (JPIA) [Preface] We, JPIA, welcome this opportunity given to comment on the above Application for Authorisation. JPIA is an industrial association of Japanese companies manufacturing and marketing plasticizer. JPIA is very interested in this Application for Authorisation, because we have a profound connection with EU through trading of Japanese articles containing chemical substances which would be required to submit the Application. This Application for Authorisation of DEHP presents the actual state of general handling of the chemical in its respective uses (including recycling). It also cites basis of argument available at present and widely recognized in the world from the scientific viewpoint for the areas concerning REACH Application for Authorisation such as toxicity, risk assessment, analysis of substitutes, socio-economic analysis. JPIA also gives full endorsement to it. Article 60 of REACH says:” an authorisation shall be granted if the risk to human health or the environment from the use of a substance arising from the intrinsic properties specified in Annex XIV is adequately controlled in accordance with Section 6.4 of Annex I and as documented in the applicant's chemical safety report, taking into account the opinion of the Committee for Risk Assessment referred to in Article 64(4)(a).” This means that nonscientific and predicative assessment and, in the lack of scientific data, excessive application of precautionary principle shall be avoided. From such the point of view, JPIA is convinced that the use applied for will be authorized. Important points of JPIA’s request are as follows: [Request] JPIA believes that the content of the Application for Authorisation submitted with relation to respective uses of DEHP by ARKEMA FRANCE, Grupa Azoty Zakłady Azotowe Kędzierzyn Spółka Akcyjna, DEZA a.s. VINYLOOP FERRARA S.p.A, (Stana RecyclingAB, Plastic Planetsrl) is valid based on the argument as below and requests your consideration to give an authorisation to the whole scope of application. [Justification for Request] 1. Reproductive toxicity JPIA has conducted various tests and studies to verify the difference in mechanism of action of DEHP in relation to the reproductive toxicity between rodents and primates (particularly human beings) for more than 10 years jointly with European Council for Plasticisers and Intermediates (ECPI) and American Chemical Council-Phthalate Ester Panel (ACC-PEP). By administering d4-labeled DEHP to marmosets (a primate species) and human volunteers and directly analyzing the urinary level of its metabolites (and their conjugates with glucuronic acid, or glucuronides), it has been shown that the metabolic machinery of DEHP such as excretion pattern and excretion rate differs between the primate including human beings and rodents and the absorption rate is lower in the formers, demonstrating that the primates has an extremely higher defensive function against toxic effects of DEHP than the rodents. 1), 2) Recent studies3), 4), 5), 6) have shown the difference in reproductive toxicity of DEHP and species difference in expression mechanism and others, indicating that DEHP does not produce toxic effects on reproduction in human beings. Concerning results from epidemiological studies was questioned about their validity7). According to Review by O. Albert, et al.8) (i) Although studies conducted in humans are limited in number, the results are quite different from those of studies using animals.  (ii) Some differences in response have been noted among rats, mice, primates and humans. Further investigations are needed to clarify the reason for. Such the controversial toxicity issue should be discussed and judged based on the results from a massive bio-monitoring project (COPHES: Consortium to Perform Human Bio-monitoring on a European Scale) presently in progress in Europe and ECOCHIL Plan9) in Japan; as mentioned in the Proposition10) by advisors of EC, excessive application of precautionary principle should be avoided. 2. Substitutes Although DINP and DIDP are conceivably the candidates of substitute for DEHP and each plasticizer has its advantage and disadvantage in performance, there is no other plasticizer than DEHP from the view point of cost-performance balance still from now on. As for non-phthalate plasticizers such as DINCH and ASE cited for substitute candidates, their use is substantially limited and special (for medical devices, etc.). Due to their performance ((e.g.) workability, compatibility, oil resistance, etc.), considerable technical difficulties are anticipated for their substitution for DEHP. And in the course of their introduction to the market, verification of a new specification for general use will required and inevitably accompanied by long period and cost increase. Moreover, such substitution connot following subjects; suppliability of raw materials and production technology (including patent issue) and lack of safety data; and, therefore, its socio-economic impact is expected to be very significant. 3. Risk assessment According to detailed risk assessments conducted in Europe, USA and Japan, as mentioned above, the major part of DEHP intake is derived from food and, in young children, intake from contact with DEHP-containing articles (mainly licking) is added and results in considerable risk (toxic effects, origin of risk, are seen in rodents but not in primates which can quickly metabolize DEHP; details are discussed earlier). This finding provides a basis for restricted use in toys as implemented in many countries. The conclusion shared by these risk assessments is: “risk is sufficiently controlled under current conditions of use” and the need of further restriction is denied. As said before, according to the Article 60 of REACH, “if the risk is sufficiently controlled as described by applicant, authorisation shall be granted”. It follows that the use applied ought to be authorized. 4. Recycle DEHP has been applied to its wide use as plasticiser of soft vinyl chloride containing-products. Many of them are excellent in material-recycling performance, with many of used articles being remanufactured into mats, floorings and others. As seen in “>2×2010 in 2020 Plan” and 2013 report of VinylPlus (Progress Report 2013), the recycling of soft vinyl chloride is very important for saving resource and energy. Since vinyl chloride-containing articles have a long service life (about 20-30 years), there will be many opportunities of their reusing for many years to come. To ensure a smooth recycling route is not only important but also very meaningful in view of reducing socio-economic loss. Moreover, as described in Vinyloop application, when compared to landfill or incineration, the recovery and reuse of soft vinyl chloride are more effective and useful from the view point of not only utilization of available resources but also waste processing of DEHP-containing articles. [References] 1) Kurata Y, Kidachi F, Yokoyama M, Toyota N, Tsuchitani M, Katoh M., Toxicological Science, 42, 49-56, 1998. 2) Tomonari Y, Kurata Y, David R M, Gans G, Kawasuso T, Katoh M., Journal of Toxicity and Environmental Health A., 69(17), 1651-1672, 2006. 3) E. Heger, et al., Environmental Health Perspectives, 120(8), 1137-1143, 2012 Human fetal testes xenografts are resistant to Phthalate-induced Endocrine disruption 4) Mitchel RT, et al., J. Clinical Endocrine & Metabo. 97(3): E341-E348 (2012) Phthalates affect steroidogenesis by the Human Fetal Testis?: Exposure of Human Fetal Testis Xenografts to Di-n-Butyl phthalate. 5) Kurata, et al., The Journal of Toxicological Science Vol. 37, No. 1, 34-39, 2012. Metabolism of di(2-ethyl hexyl)phthalate(DEHP): comparative study in juvenile and fetal marmosets and rats. 6) Kurata, et al., Ibid, Vol. 37, No.2, 401-414, 2012.   Metabolite profiling and identification in human urine after single oral administration of DEHP. 7) Michael A. Kamrin, Journal of Toxicology and Environmental Health, Part B, Volume 12, Issue 2 February 2009, pages 157-174 Phthalate Risks, Phthalate Regulation, and Public Health: A Review 8) Ocèane Albert, Bernard Jègou. Human Reproduction Update Advance Access published September 29, 2013, Vol. 0, No. 0 pp. 1-19, 2013 “A critical assessment of the endocrine susceptibility of the human testis to phthalates from fetal life to adulthood” (doi: 10.1093/humupd/dmt050 First published online: September 29, 2013) 9) http://www.env.go.jp/en/chemi/hs/jecs/ 10) Chemical Watch Thursday November 7. 2013 Download
35
Affiliation: individual

Type/ Role in supply chain:

Name of org/company:

Country: United States
Other I am the Director of the Massachusetts Toxics Use Reduction institute (TURI), which has studied both technical and substance alternatives to DEHP. Our basic conclusion is that alternatives are available, but that the specific alternatives vary by specific use. Attached is Chapter 7 of our report, "Five Chemicals Alternatives Assessment Study," titled "DEHP". TURI performed alternatives assessments for DEHP used in resilient floor covering, medical devices for neonatal care, and wall coverings. As discussed in detail in the report, other phthalates and non-phthalate plasticizers and non-PVC material alternatives were found for all three applications, but the suitable alternatives varied depending on specific use. Given the multiple uses of DEHP, all of which have different possible alternatives, it may not be appropriate to issue a broad authorization for this substance. Download
44
Affiliation: company

Type/ Role in supply chain: Manufacturer

Name of org/company: ExxonMobil Petroleum and Chemical BVBA

Country: Belgium
Substance (on its own) DINP271-090-968515-48-0Classification,Labelling and Packaging (CLP) Regulation - NOT CLASSIFIED Download
50
Affiliation: company

Type/ Role in supply chain: Manufacturer

Name of org/company: ExxonMobil Petroleum and Chemical BVBA

Country: Belgium
Substance (on its own) DIDP271-091-468515-49-1Classification,Labelling and Packaging (CLP) Regulation - NOT CLASSIFIED Download
56
Affiliation: individual

Type/ Role in supply chain:

Name of org/company:

Country: United States
Other phthalate alternativeconfidentialI direct the Chemicals Policy and Science Initiative of the Lowell Center for Sustainable Production at the University of Massachusetts Lowell. With our sister institute, the Massachusetts Toxics Use Reduction Institute, we have conducted significant research with companies across supply chains on alternatives to DEHP in a number of applications. Please see attached report where collaborative Green Screen Assessments were used to evaluate the hazards associated with eight alternatives identified for DEHP in wire and cable applications. These alternatives could be used in other DEHP applications. A second report examines alternatives to DEHP and other phthalates in a range of consumer product applications. These alternatives include alternative polymers which achieve similar flexibility and performance http://www.sustainableproduction.org/downloads/PhthalateAlternatives-January2011.pdf Our general conclusions have been that safer, cost-effective and functional alternatives to DEHP as a plasticizer in PVC applications are available for most applications. Suitable alternatives will vary by specific use, however. These alternatives may include alternative polymers that achieve flexibility through polymer manipulation without the addition of chemical plasticizers. It is important that any alternatives assessment to DEHP at least identify alternative polymers that could be used. Our experience is that to evaluate potential alternatives for a chemical like DEHP, used as a plasticizer in a number of different applications, it is critical to evaluate alternatives on based on an evaluation its functional use and performance needs for a particular application. Chemical and polymer alternatives may vary given the particular application. Given the multiple uses of DEHP, all of which have different possible alternatives, it may not be appropriate to issue a broad authorization for this substance. varies by substance/alternative Download
73
Affiliation: organisation

Type/ Role in supply chain: Member State Competent Authority

Name of org/company: Danish Environmental Protection Agency

Country: Denmark
SeveralSeveral Download
85
Affiliation: organisation

Type/ Role in supply chain: Other

Name of org/company: Allgemeine Unfallversicherungsanatalt

Country: Austria
Other Technical alternative in the processes an Substitution of the substance in the articles Download
102
Affiliation: organisation

Type/ Role in supply chain: Non-governmental organisation (NGO)

Name of org/company: Health and Environment Alliance

Country: Belgium
Other see appended document Download
107
Affiliation: company

Type/ Role in supply chain: Other

Name of org/company: Swedish Chemicals Agency

Country: Sweden
Other The Swedish Chemicals Agency has undertaken a thorough review of selected items in the application dossier(s). According to our observations the following conclusions were made: A. The scope of the application(s) is very unclear. The Swedish Chemicals Agency has examined the information about downstream uses given in the different application documents. The description of the scope varies, which makes it impossible to make an opinion about the requested authorization. There is thus reason to refuse this application based on REACH Article 62.4.c. B. It is not justified that the downstream users can handle the provided raw materials without risks under adequately controlled conditions. This will be further explained below and leads to the conclusion that the SEA route is needed for evaluation of the downstream use. C. A description and assessment is needed for every area of use included in the application. The applicant(s) describes only the situation for manufacturing, formulation and distribution of DEHP. There is no assessment of the downstream use of the material. As there are different technical solutions for different uses, a general assessment approach is not sufficient. If there is no need and no economic benefit for a downstream use of DEHP in a specified use, there is no reason for an authorization of the use of DEHP in the supply chain for that specific use. D. A range of technical feasible alternatives are already available for several uses in the application. This is reported by the applicant and thus there is reason to refuse authorization for such uses. Download
113
Affiliation: organisation

Type/ Role in supply chain: Non-governmental organisation (NGO)

Name of org/company: CHEM Trust

Country: United Kingdom
Other DEHP has already been replaced by many companies in numerous applications with different alternatives (see overview reports referred to in the non-confidential attachment). Download
122
Affiliation: organisation

Type/ Role in supply chain: Non-governmental organisation (NGO)

Name of org/company: BUND

Country: Germany
Other See 7. "other comments". Download
130
Affiliation: organisation

Type/ Role in supply chain: Industry or trade association

Name of org/company: ACEA - European Automobile Manufacturers Association

Country: Belgium
Other According to our information, technical alternatives for DEHP are available but lead time for a proper substitution is not sufficient for automotive products, see also enclosed file. Download
141
Affiliation: organisation

Type/ Role in supply chain: Non-governmental organisation (NGO)

Name of org/company: European Environmental Bureau (EEB)

Country: Belgium
Other several alternatives are provided; substances, processes and alternative methods. However, the system doesn't allow us to submit them all together. Download
146
Affiliation: organisation

Type/ Role in supply chain: Non-governmental organisation (NGO)

Name of org/company: Health Care Without Harm Europe

Country: Portugal
Other NA Download

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