EU REACH – Simplified applications for authorisation for legacy spare parts

The European Commission has published an implementing regulation simplifying applications to use authorized chemicals to produce legacy spare parts or to repair products that are no longer manufactured. The application requires a simplified format for the analysis of alternatives and socio-economic analysis. No substitution plan is needed. The application fee will also be 50 % lower than normal.

New REACH Annex XIV Authorization List Substances

Authored by Emily Tyrwhitt Jones of RINA Apr 15, 2021

ECHA recommends for the European Commission to add seven substances to the REACH Authorisation List (Annex XIV), which when included cannot be used in the EU without authorisation after the relevant sunset date. Interestingly the recommendation comes 6 months prior to deadline where ECHA is obliged to submit such recommendations, which may be part of the ‘Stronger EU legal framework to address pressing environmental and health concerns’ published under the EU chemicals strategy published in October 2020.

Proposed Substances and their Uses:

Octamethylcyclotetrasiloxane (D4) (EC 209-136-7) is used in washing and cleaning products, processing aid in the semiconductor industry, polishes and waxes. Also used to manufacture silicones such as sealants that are widely used by many industries. The last application date is proposed to be 24 months after the substance inclusion in Annex XIV.

Decamethylcyclopentasiloxane (D5) (EC 208-764-9) is used in washing and cleaning products, polishes and waxes. Also used to treat textiles and as a dye additive. Also used to manufacture silicones such as sealants that are widely used by many industries. The last application date is proposed to be 24 months after the substance inclusion in Annex XIV.

Dodecamethylcyclohexasiloxane (D6) (EC 208-762-8) is used in washing and cleaning products, polishes and waxes. Also used to manufacture silicones such as sealants that are widely used by many industries. The last application date is proposed to be 24 months after the substance inclusion in Annex XIV. It is worthwhile noting at this point that in applications where substances are used as intermediates, such as use of D4 in the manufacture of ultra-pure thin layers of silicon dioxide, are not subject to authorisation.

Terphenyl, hydrogenated (EC 262-967-7) is widely used additive in tapes, electrical insulating coating compounds, epoxy resins and coatings, polyurethane potting and moulding compounds, and electric cables. It is also used in polysulphide sealants and as a plasticiser, such as in high voltage power cables and in aircraft sealants. It is also used as a heat transfer fluid. Due to its wide ranging uses many industry sectors may be impacted by its inclusion in Annex XIV. The last application date is proposed to be 21 months after the substance inclusion in Annex XIV.

Dicyclohexyl phthalate (DCHP) (EC 201-545-9) is used as a plasticiser in a wide range of polymers including PVC. Also used as an additive in resins, paints, lacquers and varnishes to aid flexibility and to provide water-resistance in ink. The last application date is proposed to be 18 months after the substance inclusion in Annex XIV.

Disodium octaborate (EC 234-541-0) is used in paints, lubricant, adhesives and construction materials. The last application date is proposed to be 24 months after the substance inclusion in Annex XIV.

Benzene-1,2,4-tricarboxylic acid 1,2-anhydride (trimellitic anhydride, TMA) (EC 209-008-0) has no uses in the scope of the authorisation but it is included to avoid regrettable substitution in epoxy resin hardeners. The last application date is proposed to be 18 months after the substance inclusion in Annex XIV.

EU REACH – Enforcement Forum Agrees on Scope of Checks for Consumer Products and Biocides in 2022

The Forum’s 10th major enforcement project (REF-10) will focus on integrated controls of consumer products. The Forum agreed that inspectors will be able to check that products comply with many different restrictions for hazardous substances under REACH.

Among those that inspectors could check are new entries such as restrictions for carcinogenic, mutagenic and reprotoxic substances in textiles, the siloxanes D4/D5 in wash-off cosmetic products, or bisphenol A in thermal paper.

Controls will also check whether products comply with restrictions for the presence of persistent organic pollutants defined under the POPs Regulation. Here, inspectors could check PFOA in water repellent textiles or ski waxes, or short chain chlorinated paraffins in soft plastic articles.
The lists of REACH and POP restrictions that will be covered in the project are still under development but will provide much choice to the inspectors resulting in wide-ranging controls of products in the EU-EEA countries.
Enforcers will also check REACH duties for substances in articles requiring that information on substances of very high concern in products is being communicated in the supply chain.

To promote the integrated enforcement of chemicals legislation, the controls of the project will also allow inspectors to cooperate with authorities responsible for enforcing requirements of the Toy Safety and RoHS directives, which are complementary to REACH and POPs and restrict the presence of certain substances in toys, and electronic and electrical equipment.

The BPR Subgroup of the Forum agreed that inspections in its BEF-2 project will focus on controls of biocidal products for the presence of approved and non-approved active substances. The controls will be wide covering all types of biocidal product types and include both products already authorized under the BPR as well as products covered by pieces of national biocides legislation (i.e. transitional measures under Article 89 of BPR). Checks in the project may also include control labelling of biocides, online advertising, verifying that the active substance in the product is coming from an approved distributor, verifying active substances by chemical analysis, and targeted controls of disinfectants.

REF-10 and BEF-2 project will both be prepared in 2021, with inspections carried out in 2022 and reports to be published in 2023.

The Forum for Exchange of Information on Enforcement met virtually on 16-18 March 2021, while the BPRS met virtually on 23 March 2021.

India: Management and Handling of Chemicals and Hazardous Waste, Handbook, March 2021

The Handbook on Chemicals and Hazardous Waste Management and Handling in India endeavors to give a broad overview of the legislative and regulatory framework governing the chemical sector in India. Designed to serve as a ready reckoner for stakeholders working in the field of chemicals and hazardous waste, such as members and officers of the Pollution Control Boards, allied institutions of the Ministry of Environment, Forest and Climate Change, other regulatory authorities, officials and employees of hazardous waste management companies and chemical industries, importers and exporters of chemicals and waste, the Handbook outlines the core objectives of the different Acts, Rules and Regulations that regulate different aspects of chemicals and hazardous waste.

Much of the legislative framework in India that governs chemicals and hazardous waste owes its origin to different Multilateral Environmental Agreements on hazardous waste, to which India is a signatory. The Handbook also delineates the core principles of five major Conventions on hazardous waste and the obligations that the country has to fulfil in furtherance of their objectives. Spread across six chapters, the Handbook presents to its readers a holistic picture of the chemical sector in India and attempts to apprise them about the fundamental concepts that influence and govern chemical and hazardous waste management and handling in the country.

For more information see here.

EU REACH – 2020 SVHC Roadmap Complete

As part of the SVHC 2020 Roadmap launched by the Council of the EU in 2013, all relevant, currently known substances of very high concern have been identified and included on the Candidate List. Systematic screening of registered substances has been key in identifying new chemicals of concern.

ECHA has today published a brochure summarizing the achievements of the SVHC 2020 Roadmap, following its completion.

The goal of the SVHC Roadmap was to identify all relevant, currently known substances of very high concern (SVHCs) and include them on the Candidate List by 2020. SVHCs are chemicals that are carcinogenic, mutagenic or toxic to reproduction (CMRs), persistent, bioaccumulative and toxic or very persistent and very bioaccumulative (PBTs/vPvBs) and chemicals that pose an equivalent level of concern like endocrine disruptors (EDs) and sensitizers. The Candidate List now contains 211 substances.

The roadmap also aimed to efficiently identify new chemicals of concern. EU Member States and ECHA have systematically screened information on registered substances. By the end of 2020, Member States had carried out regulatory management option analysis (RMOA) on around 220 chemicals of potential concern and identified a need for further regulatory action for about 80 % of them.

As an example, dibutylbis(pentane-2,4-dionato-O,O’)tin, which is used as a catalyst and an additive for producing plastics, was first picked up as a potential carcinogenic, mutagenic or reprotoxic (CMR) substance through screening and RMOA. Its human health hazards were then confirmed by harmonized classification and labelling and it was included in the Candidate List in 2020.

For a large proportion of screened chemicals, more information from registrants is needed for authorities to be able to conclude on their hazards. When the information becomes available through substance or dossier evaluations, some of the substances are expected to have SVHC properties and will be addressed with the best regulatory instrument (e.g. authorization, restriction, or other legislation).

The SVHC Roadmap has increased the speed at which new chemicals of concern are identified as ECHA and Member States have started focusing on groups of chemically similar substances. It has also made the work of authorities more transparent by, for example, providing an overview of their work on chemicals of concern through the public activities coordination tool (PACT).

Jack de Bruijn, Director for Risk Management sums up: “While the SVHC 2020 Roadmap is complete, work will continue within ECHA’s Integrated Regulatory Strategy, which brings together various EU regulations to manage the risks of hazardous chemicals. The next goal has been set for 2027. By then, we aim to have screened all substances registered under REACH. This work contributes directly to the EU’s Chemicals Strategy for Sustainability and to the United Nations’ Sustainable Development Goals concerning chemicals.”

Progress on the Integrated Regulatory Strategy is provided in annual reports, with the next one published in April 2021.

EU REACH – 2021 Work Programme Published

ECHA’s 2021 priorities focus on its core mandate – REACH compliance, restrictions, authorization, harmonized classification and labeling, and biocides active substance approval. The Integrated Regulatory Strategy guides the work in prioritizing, evaluating and managing the risks of chemicals. The aim is to show ECHA’s impact in protecting European citizens and the environment from effects of harmful chemicals.

On 27 March 2020, the European Commission Directorate-General for Neighborhood and Enlargement Negotiations (DG NEAR) and ECDC signed an agreement for the implementation of the EU Initiative on Health Security.

This will enable tailor-made support to strengthen public health systems’ preparedness and response capacities of the European Union candidate and potential candidate and the European Neighborhood Policy partner countries, and improve health security in the European neighborhood. ECDC has developed a comprehensive programme for 2021 to enhance regional cooperation in the fields of epidemic intelligence, rapid risk assessment, preparedness and response. The goal is to empower partner countries’ professionals to better face the threats public health systems have to fight against. Several thematic events based on specific interests will be organized.

More guidance from ECHA can be found here.

EPA Seeks Public Input on Draft Guidance for PFAS Significant New Use Rule

Aggressively addressing per- and polyfluoroalkyl substances (PFAS) in the environment continues to be an active and ongoing priority for the U.S. Environmental Protection Agency (EPA). As part of these efforts, EPA is asking for public input on new draft guidance that outlines which imported articles are covered by the agency’s July 2020 final rule that prohibits companies from manufacturing, importing, processing, or using certain long-chain PFAS without prior EPA review and approval. More specifically, this guidance provides additional clarity for stakeholders that are importers of articles that may contain long-chain PFAS as part of a surface coating.

Comment deadline is January 15, 2021.

The draft guidance:

  • Provides additional clarity on what is meant by a “surface coating.”
  • Identifies which entities are regulated.
  • Describes the activities that are required or prohibited.
  • Summarizes the notification requirements of the final rule.

Upon publication of the Federal Register notice, EPA will accept comments on the guidance for 30 days in docket EPA-HQ-OPPT-2020-0621 on www.regulations.gov. EPA will use feedback received from the public comment process to inform the final guidance.

The July 2020 final rule is part of EPA’s PFAS Action Plan issued in February 2019. The cross-agency plan is the most comprehensive effort ever to address an emerging chemical of concern. Through the plan, EPA has made significant progress to help states and local communities address PFAS and protect public health.

Find a link to the draft guidance and learn more about the PFAS final rule.

Background on Draft Guidance

In July 2020, EPA issued a final rule strengthening the regulation of PFAS by requiring notice and EPA review before the use of long-chain PFAS (LCPFAC) that have been phased out in the United States could begin again. Additionally, products containing certain long-chain PFAS as a surface coating and carpet containing perfluoroalkyl sulfonate chemical substances can no longer be imported into the United States without EPA review.

This action means that articles like textiles, carpet, furniture, electronics, and household appliances that could contain certain PFAS chemicals cannot be imported into the United States unless EPA reviews and approves the use or puts in place the necessary restrictions to address any unreasonable risks.

For more information on the final rule: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-and-polyfluoroalkyl-substances-pfas

Background on PFAS Action Plan

EPA continues to make progress under its PFAS Action Plan to protect the environment and human health, including:

Drinking Water

  • In December 2019, EPA accomplished a key milestone in the PFAS Action Plan by publishing a new validated method to accurately test for 11 additional PFAS in drinking water. Method 533 complements EPA Method 537.1, and the agency can now measure 29 chemicals.
  • In February 2020, EPA took an important step in implementing the agency’s PFAS Action Plan by proposing to regulate PFOA and PFOS drinking water.
  • EPA also asked for information and data on other PFAS substances, as well as sought comment on potential monitoring requirements and regulatory approaches.
  • In November 2020, EPA issued a memo detailing an interim National Pollutant Discharge Elimination (NPDES) permitting strategy for PFAS. The agency also released information on progress in developing new analytical methods to test for PFAS compounds in wastewater and other environmental media.

Cleanup

  • In December 2019, EPA issued Interim Recommendations for Addressing Groundwater Contaminated with PFOA and PFOS, which provides guidance for federal cleanup programs (e.g., CERCLA and RCRA) that will also be helpful to states and tribes.
    • The recommendations provide a starting point for making site-specific cleanup decisions and will help protect drinking water resources in communities across the country.
  • In July 2020, EPA submitted the Interim Guidance on the Destruction and Disposal of PFAS and Materials Containing PFAS to OMB for interagency review. The guidance would:
    • Provide information on technologies that may be feasible and appropriate for the destruction or disposal of PFAS and PFAS-containing materials.
    • Identify ongoing research and development activities related to destruction and disposal technologies, which may inform future guidance.
  • EPA is working on the proposed rule to designate PFOA and PFOS as hazardous substances under CERCLA. In the absence of the rule, EPA has used its existing authorities to compel cleanups.

Monitoring

  • In July 2020, EPA transmitted the Unregulated Contaminant Monitoring Rule 5 (UCMR 5) proposal to the Office of Management and Budget (OMB) for interagency review. EPA anticipates proposing nationwide drinking water monitoring for PFAS that uses new methods that can detect PFAS at lower concentrations than previously possible.

Toxics

  • In September 2019, EPA issued an advanced notice of proposed rulemaking that would allow the public to provide input on adding PFAS to the Toxics Release Inventory toxic chemical list.
  • In June 2020, EPA issued a final regulation that added a list of 172 PFAS chemicals to Toxics Release Inventory reporting as required by the National Defense Authorization Act for Fiscal Year 2020.
  • In July 2020, EPA issued a final regulation that can stop products containing PFAS from entering or reentering the marketplace without EPA’s explicit permission.

Scientific Leadership

  • EPA continues to compile and assess human and ecological toxicity information on PFAS to support risk management decisions.
  • EPA continues to develop new methods to test for additional PFAS in drinking water.
  • The agency is also validating analytical methods for surface water, groundwater, wastewater, soils, sediments and biosolids; developing new methods to test for PFAS in air and emissions; and improving laboratory methods to discover unknown PFAS.
  • EPA is developing exposure models to understand how PFAS moves through the environment to impact people and ecosystems.
  • EPA is working to develop tools to assist officials with the cleanup of contaminated sites.
  • In July 2020, EPA added new treatment information for removing PFAS from drinking water.

Technical Assistance

  • Just as important as the progress on PFAS at the federal level are EPA efforts to form partnerships with states, tribes, and local communities across the country.
  • EPA has provided assistance to more than 30 states to help address PFAS, and the agency is continuing to build on this support.
  • These joint projects allow EPA to take the knowledge of its world-class scientists and apply it in a collaborative fashion where it counts most.

Enforcement

  • EPA continues to use enforcement tools, when appropriate, to address PFAS exposure in the environment and assist states in enforcement activities.
  • EPA has already taken actions to address PFAS, including issuing Safe Drinking Water Act orders and providing support to states. See examples in the PFAS Action Plan.
  • To date, across the nation, EPA has addressed PFAS in 15 cases using a variety of enforcement tools under SDWA, TSCA, RCRA, and CERCLA (where appropriate), and will continue to do so to protect public health and the environment.

Grants and Funding

  • Under this Administration, EPA’s Office of Research and Development has awarded over $15 million through dozens of grants for PFAS research.
  • In May 2019, EPA awarded approximately $3.9 million through two grants for research that will improve the agency’s understanding of human and ecological exposure to PFAS in the environment. This research will also promote a greater awareness of how to restore water quality in PFAS-impacted communities.
  • In September 2019, EPA awarded nearly $6 million to fund research by eight organizations to expand the agency’s understanding of the environmental risks posed by PFAS in waste streams and to identify practical approaches to manage potential impacts as PFAS enters the environment.
  • In August 2020, EPA awarded $4.8 million in funding for federal research to help identify potential impacts of PFAS to farms, ranches, and rural communities.

Highlighted Action: Risk Communications

  • EPA is working collaboratively to develop a risk communication toolbox that includes multimedia materials and messaging for federal, state, tribal, and local partners to use with the public.

Additional information about PFAS can be found at: www.epa.gov/pfas

Canada Publishes Final Decision after Phthalate Substance Screening Assessment

Summary of screening assessment of the Phthalate Substance Grouping

Pursuant to sections 68 and 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of 14 phthalate esters (phthalates), known collectively as the Phthalate Substance Grouping.

Substances in this grouping were identified as priorities for assessment as they met categorization criteria under subsection 73(1) of CEPA or were considered a priority on the basis of other human health concerns. This screening assessment follows the August 2015 publication of four state of the science (SOS) reports and an approach document for cumulative risk assessment (CRA) of phthalates, and it presents information relevant to concluding on the substances in this grouping under section 64 of CEPA.

The Chemical Abstracts Service Registry Numbers, Domestic Substances List (DSL) names and acronyms for phthalates in the Phthalate Substance Grouping screening assessment are listed in the table below.

Substances in the Phthalate Substance Grouping

CAS 131-11-3: 1,2-Benzenedicarboxylic acid, dimethyl ester

CAS 84-69-5:  1,2-Benzenedicarboxylic acid, bis(2-methylpropyl) ester

CAS 5334-09-8:  1,2-Benzenedicarboxylic acid, cyclohexyl 2-methylpropyl ester

CAS 84-64-0:    1,2-Benzenedicarboxylic acid, butyl cyclohexyl ester

CAS 84-61-7: 1,2-Benzenedicarboxylic acid, dicyclohexyl ester

CAS 523-31-9:  1,2-Benzenedicarboxylic acid, bis(phenylmethyl) ester

CAS 68515-40-2: 1,2-Benzenedicarboxylic acid, benzyl C7-9-branched and linear alkyl esters

CAS 27987-25-3: 1,2-Benzenedicarboxylic acid, bis(methylcyclohexyl) ester

CAS 71888-89-6: 1,,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich

CAS 27215-22-1: 1,2-Benzenedicarboxylic acid, isooctyl phenylmethyl ester

CAS 16883-83-3: 1,2-Benzenedicarboxylic acid, 2,2-dimethyl-1-(1-methylethyl)-3-(2-methyl-1-oxopropoxy)propyl phenylmethyl ester

CAS 68515-48-0/ 28553-12-0:  1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich; 1,2-Benzenedicarboxylic acid, diisononyl ester

CAS 26761-40-0 / 68515-49-1: 1,2-Benzenedicarboxylic acid, diisodecyl ester; 1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich

CAS 3648-20-2:   1,2-Benzenedicarboxylic acid, diundecyl ester.

Fourteen additional phthalates on the DSL were included within the scope of the screening assessment in the context of their potential to contribute to cumulative risk from combined exposure to phthalates.

On the basis of the information presented in this screening assessment, it is concluded that all 14 phthalates in the Phthalate Substance Grouping do not meet the criteria under paragraph 64(c) of CEPA as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health. Also, the previous conclusion made in the 1994 PSL assessment of DEHP, that it meets the criteria under paragraph 64(c) of CEPA, remains valid.

Overall conclusion

It is concluded that DEHP meets one or more of the criteria set out in section 64 of CEPA, and that the other 14 substances in the phthalate substance grouping do not meet any of the criteria set out in section 64 of CEPA.

DEHP has been determined to not meet the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.

Public comment period on the risk management approach

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the proposed risk management approach document. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical Substances) website. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be addressed to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819‑938‑5212, by email to eccc.substances.eccc@canada.ca, or by using the online reporting system available through Environment and Climate Change Canada’s Single Window.”

Canada: Environmental Protection Act, c.33 1999, Reporting Requirements for Perfluorohexane Sulfonic Acids (PFHxS)

On 10 October 2020, the Canadian Minister of the Environment issued a Notice requiring that any person involved in the manufacture, use, export or import of perfluorohexane sulfonic acid, its salts and its precursors (PFHxS) submit certain information no later than 20 November 2020. The objective is to assess whether the 33 substances listed in Schedule 1 of this Notice shall be subject to control and if so, determine the manner in which such a control shall be implemented.

This notice applies to any person, or class of persons designated the successor or assign of a person, who, during the 2019 calendar year:

  • manufactured a total quantity of greater than 1 000 g of any substance [listed on Schedule 1 to this Notice];
  • imported a total quantity greater than 10 g of any substance, whether the substance was alone or at a concentration equal to or above 1 ppm in a mixture, in a product or in a manufactured item;
  • used a total quantity greater than 10 g of any substance, whether the substance was alone or at a concentration equal to or above 1 ppm in a mixture or in a product, in the manufacture of a mixture, a product or a manufactured item; and
  • exported a total quantity greater than 10 g of any substance, whether the substance was alone or at a concentration equal to or above 1 ppm in a mixture, in a product or in a manufactured item.

It does not apply to a substance [listed on Schedule 1 to this Notice], whether alone, in a mixture, in a product or in a manufactured item that:

  • is imported or exported for use in a laboratory for analysis, in scientific research or as a laboratory standard;
  • is, or is contained in, a hazardous waste or hazardous recyclable material within the meaning of the Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations and was exported or imported pursuant to a permit issued under these Regulations; and
  • is, or is contained in, a pest control product registered under the Pest Control Products Act.

According to this notice, the persons identified shall provide the following information:

  1. the name of the person reporting;
  2. the address;
  3. the federal business number;
  4. the name of an individual authorized to act on behalf of the person, email and phone number; and
  5. a declaration that the information is accurate and complete.

For each substance [listed on Schedule 1 of this Notice] that a person manufactured or imported, whether alone, in a mixture, in a product or in a manufactured item, during the 2019 calendar year, the following information shall also be provided:

  1. the CAS RN of the substance;
  2. whether the person manufactured or imported the substance by indicating “yes” or “no”;
  3. the total quantity of the substance that the person manufactured or imported, reported in grams;
  4. each substance function code set out in Schedule 2 that applies to the substance;
  5. each application code set out in Schedule 3 that applies to the substance; and
  6. for each application code provided, the description and the common or generic name of the known or anticipated final goods containing the substance.

Where code U999 is provided, a written description of the function associated with the substance must be provided.

Where code C999 is provided, a written description of the application associated with the substance must be provided.

Slightly different information is required from persons who, during the 2019 calendar year, used or exported the targeted substances (whether alone, in a mixture, in a product or in a manufactured item) in accordance with sections 9 and 10 of the Notice.

Responses to this notice can be submitted to the Minister of the Environment, using the online reporting system available through Environment and Climate Change Canada’s Single Window.  Claims for confidentiality will be approved if the information submitted is found to be confidential under Canadian law and the Act. Requests to extend the deadline to submit the above information may be submitted to the Minister at the following email address: eccc.substances.eccc@canada.ca.

EU REACH – ECHA’s committees back restricting over 1000 skin sensitizing chemicals used in clothing and other articles

The Committee for Socio-economic Analysis (SEAC) supports France and Sweden’s proposal to restrict the use of skin sensitizing substances in clothing, footwear and other articles with similar skin contact. If adopted, the restriction will prevent many people from developing new skin allergies while also relieving the symptoms of many of those who already have them. This is expected to result in health benefits equivalent to at least €708 million per year.

SEAC adopted its final opinion on France and Sweden’s proposal to restrict skin sensitizing substances in textile, leather, synthetic leather, hide and fur articles, that are placed on the market for the first time. This follows an earlier opinion by the Committee for Risk Assessment (RAC) in March 2020. Both committees concluded that an EU-wide restriction is the most appropriate means to address the risks to EU citizens. In addition, SEAC concluded that the expected benefits and costs to society of the proposal mean that it is likely to be proportionate.

Skin sensitization is a health effect that leads to a lifelong sensitivity to a specific allergen. Currently, there is a growing concern about skin sensitization from exposure to chemicals in textile and leather products: it is estimated that up to 5 million people in the European Economic Area are already sensitized and up to 180 000 new cases occur each year.

The proposed restriction covers substances that have a harmonized classification as skin sensitizers under the Classification, Labelling and Packaging (CLP) Regulation such as chromium VI, nickel and cobalt compounds. It also proposes to restrict some dyes that are considered to have skin sensitizing properties, but which do not have a harmonized classification. The proposal introduces a link with the CLP Regulation meaning that any substance that is classified as a skin sensitizer in the future under CLP would automatically be covered by the restriction. When substances are automatically added to the restriction, SEAC recommends a transitional period of three years between classification and the conditions of the restriction taking effect to allow manufacturers to adapt.

If adopted by the European Commission, the restriction will prevent many new skin allergies while also relieving the symptoms of many people who already have them. This is expected to save European society at least €708 million a year in reduced healthcare costs, productivity losses (e.g. due to sick leaves) and welfare losses (in terms of reduced quality of life due to the allergy). The raw material costs for industry to replace the chemicals are estimated to be up to €23.8 million per year. There will also be costs related to reformulation, testing and enforcement.

Following SEAC’s adoption, the opinions of both RAC and SEAC as well as the proposal of France and Sweden will be sent to the European Commission, which will take the decision together with the EU Member States.