Regulatory Developments

ECHA’s Management Board Supports Efforts To Improve REACH Authorization And Evaluation and Other Recent REACH Developments

July 12, 2019 PRINT

ECHA’s Management Board Supports Efforts To Improve REACH Authorization And Evaluation: On June 20, 2019, ECHA issued a press release entitled “Management Board supports efforts to improve REACH authorisation and evaluation.” In its press release, ECHA provides that its Management Board “has expressed its confidence in the plans to adjust the process for applications for [authorization].” The Management Board also welcomed the joint action plan of ECHA and the EC to improve the compliance of registrations under the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation.

Sharon McGuinness, Chair of ECHA’s Management Board, stated:

ECHA is investing a lot to improve these two critical processes for the future of REACH, in line with the recommendations of the second Commission review of REACH. For applications for authorisation, it has duly considered the recent Court cases, listened to the [European Parliament (EP)] and other stakeholders and taken their feedback seriously. As for REACH evaluation, the joint action plan paves the way to address the lack of compliance of many registration dossiers.

ECHA’s press release provides that “work on authorisation” will be improved in three ways: (1) ECHA’s formats for applications for authorization will require applicants to provide a substitution plan in their application if there are suitable alternatives available in general, but they are not yet feasible for the applicant; (2) ECHA will revise the opinion formats utilized by RAC and SEAC, and this is expected to “also clarify the boundaries between scientific opinion making by ECHA’s committees and the decisions by the Commission”; and (3) ECHA will standardize the opinion texts to help rapporteurs build up more consistent and concise opinions.

ECHA’s Management Board described the joint evaluation action plan by ECHA and the EC as “the right way to achieve a high degree of compliance with the legal requirements of REACH.” Ms. McGuinness stated further that “[t]he Board encourages [ECHA] to continue to work with its stakeholders, further improve these key processes and take action where necessary ... We will be looking forward to receiving information on the progress of these improvement actions.”

ECHA To Scrutinize All REACH Registrations By 2027: On June 24, 2019, ECHA issued a press release entitled “ECHA to scrutinise all REACH registrations by 2027.” In its press release, ECHA indicates that it will start to evaluate 20 percent of registration dossiers in each tonnage band to improve the compliance of REACH registrations. ECHA states “[t]his will mean approximately 30 % of all registered chemicals will be checked.” ECHA indicates that the EC will propose an amendment to the REACH regulation “to raise the current 5 % minimum target for compliance checks to 20 % of registration dossiers in each tonnage band.” The increased target is part of the joint action plan, coordinated by ECHA and the EC, to address the lack of compliance in registration dossiers and encourage industry to improve its safety data on chemicals.

ECHA indicates in the press release that its aim “is to screen all registration dossiers submitted by the 2018 deadline: by 2023 for substances registered over 100 tonnes per year and by 2027 for substances in the tonnage band 1-100 tonnes per year.” ECHA will “also check the compliance of at least 30 % of substances, making sure that this check is done for all substances where more information is needed.” ECHA indicates that “[t]hese include, for example, substances with hazardous properties, or where more data needs to be generated to conclude a potential risk.”

ECHA provides that similar substances will be assessed in groups to gain efficiency and ensure that proposals for further regulatory action are consistent. For high tonnage substances, ECHA will conclude by the end of 2020 “whether they are a priority for risk management, for data generation or currently of low priority for further action.” ECHA indicates that, to meet its ambitious targets, it will re-allocate staff from other functions to evaluation tasks. ECHA provides that “[o]ther actions include simplifying compliance check decisions, increasing enforcement, interaction with industry associations to make sure registrants step up their compliance efforts, and establishing a transparent monitoring system of the progress made.”

The European Chemical Industry Council (Cefic) issued a June 26, 2019, press release entitled “Cefic launches Action Plan to help REACH registrants review chemical safety data.” According to the press release, in response to ECHA’s conclusion that many REACH registration dossiers required additional information, Cefic has developed a multi-annual Action Plan that provides a framework for REACH registrants to evaluate the safety data in a stepwise manner. The Action Plan outlines the timeline, roles and responsibilities, substance prioritization criteria, critical issues, and explains how progress will be reported. The Action Plan will run from 2019-2026, allowing for one year of planning and setting up and “seven years of actual updates.”

EC Issues Report On Fitness Check Of Most Relevant Non-REACH Chemicals Legislation: On June 25, 2019, the EC issued a press release and report concerning the findings of the Fitness Check of the “most relevant chemicals legislation (excluding REACH).” The EC’s press release states:

The [EC] has published a review of the EU chemicals legislative framework, which addresses some 40 pieces of sectoral chemicals legislation . . . [The report confirms] that the rules in place provide a high level of protection against harmful chemicals for our citizens and the environment and that they contribute to an efficient functioning of the single market. The EU has one of the most comprehensive legal frameworks in the world, which offers a global benchmark for chemical risk management.

The report also identifies certain areas for improvement in the implementation and application of the rules, including the need for the simplification and streamlining of hazard and risk assessment processes, providing better consumer information, and supporting implementation of the legislation by the EU countries.

The EC’s report provides that the Fitness Check assessed whether the EU chemicals legislation meets its objectives in terms of risk and hazard assessment and management of hazardous chemicals, and “if it does so in a coherent and efficient way.” The report “concludes that, overall, the EU chemicals legislation delivered results as intended and is fit-for-purpose.” The assessment carried out for the purposes of the Fitness Check focused on the chemical hazard, risk assessment, and risk management processes specified by the different pieces of legislation considered. The REACH regulation and pharmaceutical, veterinary products, and food additives legislation were excluded from the scope of the assessment.

The Fitness Check identified a number of challenges, gaps, and weaknesses that affect the correct functioning of EU chemicals legislation “from a framework and a more general perspective and that are holding it back from delivering its full potential.” The report identifies challenges, gaps, and weaknesses in the following areas:

  • Implementation and enforcement;
  • Duplication, burdens, and pace of procedures;
  • Communication of hazard and safety information;
  • Consistency of risk management measures;
  • Risk assessment, knowledge gaps, and challenges in keeping up with science; and
  • Global competitiveness, innovation, and sustainability.

In the “Conclusions” section, the report states “[w]e have come a long way and this Fitness Check has found that, overall, the EU framework of chemicals legislation is fit for purpose and delivers a high level of protection of people and the environment in balance with the needs of an efficiently functioning internal market and of a competitive and innovative chemicals industry … It has also found a number of areas where there is scope for further improvement, simplification and burden reduction or that warrant attention.” The findings of the Fitness Check “will help ensure” that any improvements and refinements to be made in the chemicals policy area are “well-founded and well-focused.”

Further information is available in the EC’s Staff Working Document.

Enforcement Forum To Conduct Pilot Project On Classification Of Mixtures: On June 25, 2019, ECHA issued a press release entitled “Enforcement Forum: inspectors to look into classification of mixtures.” In its press release, ECHA provides that its Forum for Exchange of Information on Enforcement (Enforcement Forum) “agreed to conduct a pilot project to check the classification of mixtures, including detergents and cleaning products.” The timing for this project will be decided in November 2019.

The Enforcement Forum also discussed the impact of the REACH Evaluation Joint Action Plan on enforcement activities. The plan identifies a number of actions for ECHA and the EC that aim to help ECHA check the compliance of 20 percent of dossiers in each tonnage band by 2027. Some of these actions address enforcement (e.g., ECHA plans to prepare a compilation of measures available to inspectors in their Member States). This information could be used by inspectors to address non-compliance with dossier evaluation, and to explore if ECHA could further support enforcement authorities in taking action when there is misuse of the evaluation process. The Enforcement Forum will work together with the ECHA Secretariat to assess whether and how such actions can be implemented.

ECHA’s Enforcement Forum recently issued a “Report on Improvement of Quality of SDS” that identified a number of common deficiencies in key sections of SDSs. The report “also formulates a number of recommendations about how these deficiencies could be addressed.” The Enforcement Forum Working Group met with stakeholders to explore if there are any solutions that stakeholder organizations can implement to improve SDS quality, “with a view to presenting them at the [Enforcement Forum] open session in November 2019.”

The Enforcement Forum met on June 18-19, 2019, and the Biocidal Products Regulation Subgroup (BPRS) met on June 20, 2019, in Helsinki.

Council Of The EU Adopts Conclusions On Chemicals To Offer Political Guidance On Sustainable EU Chemicals Policy Strategy: On June 26, 2019, the Council of the EU announced that it adopted conclusions on chemicals intended to “offer political guidance on the development of a sustainable EU chemicals policy strategy.” In its conclusions, the Council underlines the need to protect human health and the environment through the sound management of chemicals, and highlights the need to improve and mainstream the chemical risk assessment and management of chemicals across EU legislation to increase the coherence and effectiveness of EU chemicals-related legislation. The June 26, 2019, press release notes that the conclusions also address the following topics:

  • Pharmaceuticals: The Council stresses the importance to accelerate “concrete and ambitious actions to reduce the risk from pharmaceuticals and their residues to the environment”;
     
  • REACH: The Council calls upon the EC and ECHA to develop by December 2019 an action plan on dossier compliance for REACH. The Council also stresses the importance of improving the REACH authorization and restriction procedures;
     
  • Nanomaterials: The Council requests the EC to extend ECHA’s mandate to collect and make available research data on the characterization, the hazard, and potential exposure of nanoforms of substances that were so far not registered under REACH because their yearly tonnage is below the threshold of one tonne/year and to ask ECHA to evaluate the performance and the impact of the EU Observatory for Nanomaterials (EUON); and
     
  • Endocrine disruptors: The Council urges the EC to ensure a high level of protection of human health and the environment by minimizing exposure to endocrine disruptors and by stimulating substitution by safer chemicals, as far as technically and practically possible, and to provide, without undue delay, an action plan with clear and concrete measures and an ambitious timeline for doing so.

EUON Search Tool Includes Over 300 Nanomaterials On The EU Market: EUON announced on July 3, 2019, that it has added a new search tool for nanomaterials to its website. The search tool combines data submitted by companies in their REACH registration dossiers, data collected about nanomaterials used as ingredients in cosmetic products under the Cosmetics Regulation, and data from the Belgian and French public national nanomaterial inventories. Search results are linked to ECHA’s database of chemicals registered in the EU.

ECHA Completes Major Update To Chemicals Database: On July 3, 2019, ECHA issued a press release entitled “Major update to ECHA’s chemicals database.” In its press release, ECHA provides that several new features and improvements are now publicly available in its chemicals database. These features include “new information in substance Infocards, quick links to deeper datasets for each substance and more visibility on nanomaterials.” ECHA indicates that the “properties of concern section in the Infocards has been extended and the search possibilities for substances based on these properties [have] been likewise extended.”

ECHA provides that the current regulations and regulatory activities section in its database has been restructured and the “different regulatory lists are now laid out by legislation in expandable blocks, with explanations why the substances are on key lists.” ECHA indicates that the other identifiers section has also been improved and restructured to include all public identifiers, including translated names.

ECHA’s new quick links to key datasets for each substance give users “a faster way to browse through more data-rich datasets, such as the Brief Profiles, REACH registered substance factsheets, the Classification and Labeling (C&L) Inventory, biocides data and the public activities coordination tool (PACT).” ECHA provides that its advanced search function has also been extended and restructured, allowing for new search possibilities (e.g., advanced C&L search also covers Seveso Directive data).

ECHA’s Infocards now have a new nanomaterial form section, which indicates whether the substance is placed on the market in nanoform and provides links to EUON. As reported above, through EUON’s search tool for nanomaterials, information on over 300 nanomaterials on the EU market can be found and linked to hazard data.

In conclusion to its press release, ECHA states “disseminated REACH registration data will now start to be automatically linked to the OECD’s eChemPortal.”

ECHA Recommends Adding Endocrine Disrupting Properties To Four Phthalates On Authorization List: ECHA announced on July 10, 2019, that it has submitted a recommendation to the EC to amend the Authorization List to include endocrine disrupting properties in the respective entries of:

  • Bis(2-ethylhexyl) phthalate (DEHP);
     
  • Benzyl butyl phthalate (BBP);
     
  • Dibutyl phthalate (DBP); and
     
  • Diisobutyl phthalate (DIBP).
     

Once the EC decides on the amendment, some previously exempted uses will require authorization. The actual amendment of the entries, including the final decision on the dates by which companies will need to apply for authorization and on exempt uses, will be made by the EC in collaboration with Member States and the EP.

EC Publishes First Review Of Detergents Regulation: The EC announced on July 10, 2019, that it published its first review of the detergents regulation since its entry into force in 2004. According to the EC, the review “confirmed that the detergents regulation has made it easier for companies to trade cross border and has levelled the playing field for detergents’ manufacturers.” Data from Eurostat, supported by data from the detergents industry, “show a steady growth of both the detergents market and the detergents industry since the entry into force of the regulation.” The EC notes that the regulation also had a positive impact on the environment through improved biodegradability rules that ensure that consumer detergents are broken down to water, carbon dioxide, and biomass. In 2012, the EC introduced phosphorus limits for consumer laundry and consumer automatic dishwasher detergents to lower the amount of phosphorus used in detergents and reduce the damage that phosphates from detergents may have on ecosystems and aquatic environments (eutrophication). The EC states that the regulation increased protection of human health by giving consumers online access to the full list of ingredients contained in detergents. By providing information on the content of allergenic fragrances on detergents’ labels, consumers can make informed choices and potential reactions related to the use of detergents are therefore reduced.

The evaluation identified areas for improvement, the main one being the need to provide clearer information to consumers. According to the EC, some of the rules of the detergents regulation are inconsistent and/or overlap with other EU chemicals legislation and often lead to duplications in the labeling of detergents. These duplications contribute to the overload of detergents labels, resulting in unclear information to consumers and an unnecessary burden for the detergents industry. The EC suggests that these issues could be addressed with the use of innovative communication methods and digital tools such as Q-R codes.

Court Confirms Identification Of BPA As An SVHC: On July 11, 2019, the General Court of the European Union issued a press release announcing its decision that “a substance used as [an] on-site isolated intermediate or as a transported isolated intermediate is not automatically exempted” from REACH, and thus does not escape the REACH SVHC identification procedure. PlasticsEurope challenged ECHA’s 2017 decision to designate bisphenol A (BPA) as an SVHC without explicitly excluding intermediate uses. The court notes that the exemption laid down in REACH Article 2(8)(b) concerns only the authorization procedure. By contrast, REACH “does not preclude a substance from being capable of being identified as being of very high concern, even though it is used merely as an on-site or transported isolated intermediate.” The court states that it “considers that the use of a substance as an intermediate is not relevant, since the information relating to that use does not concern the intrinsic properties of that substance whereas the identification and inclusion of a substance in the candidate list of substances are carried out solely on account of the intrinsic properties of a substance and not on account of the uses of that substance.”

ECHA Working To Identify And Regulate POPs: ECHA has begun working on scientific, technical, and administrative tasks to identify and regulate persistent organic pollutants (POP). The POPs Regulation bans or severely restricts the production and use of POPs in the EU. ECHA states that it will support the identification of new POPs. It will also act as an interface for reporting duties on implementing the regulation. This includes compiling and publishing information from the Member States on uses, volumes, releases, monitoring data, stockpiles, and waste related to POPs, as well as supporting the EC to review and update the future activities to progress further in combatting the risks caused by POPs. ECHA states that in 2020 it will integrate data on POPs to its chemicals database to enable easier access to regulatory and hazard-related information on listed and proposed POPs. More information is available in ECHA’s July 15, 2019, press release, “ECHA starts work on persistent organic pollutants.”

ECHA Adds Four New Substances To Candidate List: ECHA announced on July 16, 2019, that it added four new substances to the Candidate List due to their toxicity to reproduction, endocrine disruption, and a combination of other properties of concern. ECHA states that the latter causes probable serious effects to human health and the environment, giving rise to an equivalent level of concern to CMR, PBT, and vPvB substances, respectively. ECHA notes that the decision to include two of the substances, number 2 and 3 in the table below, was taken with the involvement of the MSC. One further substance, the last in the table below, has been added to the list having been identified as an SVHC by the EC due to its endocrine-disrupting properties. The MSC referred this SVHC proposal to the Commission in 2016.

Substance Name

Reason for Inclusion

Examples of Use(s)

2-methoxyethyl acetate

Toxic for reproduction (Article 57 (c))

Not registered under REACH

Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP)

Endocrine disrupting properties (Article 57(f) -- environment)

Primarily used as an antioxidant to stabilize polymers

2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides (covering any of their individual isomers and combinations thereof)

Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)

Equivalent level of concern having probable serious effects to human health (Article 57(f) – human health)

Processing aid in the production of fluorinated polymers

4-tert-butylphenol

Endocrine disrupting properties (Article 57(f) -- environment)

Used in coating products, polymers, adhesives, sealants, and for the synthesis of other substances

More information is available in ECHA’s July 16, 2019, press release, “Four new substances added to the Candidate List.”

ECHA Guideline Intended To Help Users Comply With NMP Restriction: ECHA announced on July 17, 2019, that it published a new guideline intended to help industrial users of 1-methyl-2-pyrrolidone (NMP) comply with the substance’s restriction requirements. ECHA notes that the guideline is needed “because this is the first restriction of its kind that is based on Derived no Effect Levels (DNEL).” According to ECHA, NMP is used as a solvent or surface deposition medium during manufacturing and is therefore a critical substance for various industries producing batteries, semiconductors, fibers, and pharmaceuticals. NMP users in these sectors have to comply with the restriction by May 9, 2020. For NMP used in wire coatings, the deadline is May 9, 2024. ECHA states that the general approach described in the guideline “can also be applied to other aprotic solvents similar to NMP, such as DMF and DMAC, if similar REACH restrictions are introduced for other aprotic solvents at a later stage.” More information is available in ECHA’s July 17, 2019, press release, “Advice on how to comply with NMP restriction.”

ChemSec Will Launch Major Update To SIN List In November 2019: The International Chemical Secretariat (ChemSec) will hold “Ready, Set, Substitute It Now!” in Brussels on November 14, 2019. ChemSec states that the one-day event “will launch a major update to the SIN List, adding both new substances and new substance categories to it.” The event will also “feature messages from policy makers, inspiration from progressive companies and hard facts from scientists, as well as panel discussions and workshops on how to best substitute these hazardous chemicals.” The Substitute It Now! (SIN) List groups substances according to structural similarity. Almost all of the current SIN List substances are divided into 31 groups, and some SIN chemicals belong to several groups. Examples of these groups are bisphenols, phthalates, and perfluorinated compounds.

CHEM Trust Issues Judicial Review Pre-Action Protocol Letter To Government For Post-Brexit Chemicals Legislation: On June 4, 2019, CHEM Trust’s lawyers, Leigh Day, sent a “legal letter” to the UK’s Secretary of State for Environment, Food and Rural Affairs “arguing that [the UK Government’s] proposed post-Brexit rules for chemicals and pesticides were not [a] proper reflection of the EU laws they were supposed to be copying.” The letter addressed the following post-Brexit chemical laws:

Leigh Day’s letter provided further that it should be accepted as a “formal letter” before action “as required by the [Civil Procedure Rules (CPR)] pre-action protocol governing claims for judicial review.” The letter indicated that the matter at hand “may give rise to judicial review proceedings,” and that the letter was provided to give the Government a “chance to respond to the relevant issues (including explaining any disagreement [with] the factual or legal situation [as explained in the letter]) in the hope of avoiding litigation.”

The letter provided the following as “grounds” to the challenge: (1) “[a] legitimate expectation of equivalent environmental protection”; and (2) Section 8(1) of the Withdrawal Act. Under the letter, CHEM Trust sought the following remedies:

  • A declaration that the Secretary of State for the Environment, Food and Rural Affairs has acted “both contrary to the legitimate expectation that current environmental protection will not be weakened as the UK leaves the EU and ultra vires his powers under section 8(1), and paragraph 1 of Schedule 4 and paragraph 21 of Schedule 7 to, the Withdrawal Act” with respect to the UK REACH Statutory Instrument and the UK PPP Statutory Instrument “and/or for an improper purpose by reference to those provisions”;
     
  • An order “quashing the offending text” from the UK REACH Statutory Instrument and UK PPP Statutory Instrument; and
     
  • An order for costs.
     

CHEM Trust requested a response to its letter by June 18, 2019. In conclusion, the letter stated “[i‌]n the event that we do not receive a satisfactory response to this letter on or before [June 18, 2019,] we will issue proceedings seeking permission from the High Court to proceed with the proposed claim for judicial review as outlined above.”

On July 9, 2019, CHEM Trust issued a press release entitled “Brexit: UK Government commits to not ‘undermine’ public participation and stakeholder involvement in chemical laws.” In its press release, CHEM Trust indicates that since issuance of the letter by Leigh Day, the “Government re-drafted the pesticides rules, claiming that there had been a ‘drafting error.’” CHEM Trust states this “was surprising given that they deleted the most controversial part of the EU’s pesticides law, the ban on endocrine (hormone) disrupting chemicals.”

CHEM Trust indicates that, “after some delay,” it received a government response to its concerns outlined in the letter. Based on the response, CHEM Trust “decided not to proceed further with [its] legal action on the [UK REACH Statutory Instrument] at this time, but instead to focus on ensuring that any implementation of this [Statutory Instrument] is in line with the commitments made by the Government.”

CBA Offers Suggestions For UK REACH Workability: On June 24, 2019, the Chemical Business Association (CBA) issued a press release entitled “CBA Publishes Plan To Make UK REACH Workable.” In its press release, CBA states that it has proposed a solution that will make UK REACH workable by solving the “crucial issue of access to testing data.” CBA indicates that its proposal would “also ensure that UK companies have continued frictionless access to the EU market post-Brexit as well as EU companies enjoying a similar level of access to the UK Market.”

CBA has suggested that EU REACH Substance Information Exchange Forums (SIEF) “currently holding the majority of chemical test data supporting EU REACH registrations” should be allowed to submit a full registration dossier to the UK’s Health and Safety Executive (HSE). CBA states that, under its proposal, “[t]his would apply equally to lead registrants and SIEFs whether they are based in the EU or the UK.” CBA has proposed that this process would be free of charge to the registrant, and indicates that the Department for Environment, Food, and Rural Affairs (DEFRA) is considering its proposal.

CBA states that, under its proposal, “SIEF participants in the UK holding valid EU REACH registrations would be able to negotiate an extension to their current ‘Letter of Access’ to cover the UK regime.” CBA provides further that, under its proposal, new UK REACH registrants would notify HSE and be directed to the “European SIEF” to obtain access to the data package in the “same way as EU REACH currently operates.” CBA also indicates that, under its proposed arrangements, if a European SIEF elected to perform new tests or gather further data, “they would then update both ECHA (EU REACH) and HSE (UK REACH), so ensuring future consistency.”


 
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