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Top International News in Chemical Policy and Regulation- September 2017: European Union

Cefic Provides Circular Economy Comments On EC’s Stakeholder Consultation: In July, the European Chemical Industry Council (Cefic) provided comments in response to the European Commission’s (EC) “Stakeholder Consultation Paper” on chemicals, products, and waste legislation. In its “feedback to the targeted consultation,” Cefic responded to each of the key issues identified in the EC’s consultation paper.

Regarding the first issue of “insufficient information about substances of concern in products and waste,” Cefic stated that it “[sees] in particular a role for an enhanced supply chain collaboration, facilitated via the channels of sectorial associations in case of existing information gaps when (parts of) post-consumer waste is being brought back in the economy.” Cefic acknowledges that knowledge gaps at the recycling stage regarding the presence or absence of certain substances will not be solved simply by increased information provided through the value chain because the gaps result also from the lack of information related to imported articles and uncontrolled contamination during use, collection, and sorting phases.

To close information gaps, Cefic suggests that recyclers undertake an assessment of products they want to place on the market for the intended applications to ensure compliance with the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation, Classification, Labelling, and Packaging (CLP) Regulation, and/or applicable sector regulations. Cefic also proposes the establishment of “value chain platforms, including the recyclers, facilitated via the channels of sectorial associations to exchange information about the presence of substances in the products and support the risk assessment.” Cefic also identifies examples of successful value chain collaboration (e.g., Global Automotive Declarable Substance List).

On the second issue of “presence of substances of concern in recycled materials and in articles made thereof,” Cefic stated that it is in favor of a “case-by-case risk-based approach, application oriented, within the framework of existing chemical legislation, provided the use in the application under consideration is safe.” Cefic indicates that additional supporting guidance derived from REACH guidance, for informed decision taking in case of recycling, with due consideration to the presence of substances of concern including legacy chemicals “might be useful to indicate circular economy inspired options.” Cefic states in its comments document that REACH and CLP are “appropriate” and should remain the “guardian-legislation” at the entrance of any new material cycle. Cefic suggests that the EC “stimulate a better integration of circular economy thinking into the implementation of existing legislation through providing further clarifications and guidance.” Cefic states “[‌i]n this respect it should be clear that a pragmatic risk-based application of REACH is necessary to make [the] circular economy successful.” In its comments, Cefic provides further detail on legacy chemicals and imported materials, and suggests practices for “[keeping] more secondary raw materials circulating in the economy.”

On the third issue of “uncertainties about how materials can cease to be waste,” Cefic “calls for a harmonized, pragmatic approach, oriented towards removing all barriers towards a circular economy.” Cefic recognizes that the practicalities of managing post-consumer articles and industrial process waste are significantly different and states that in the long-run to ensure a smooth transition towards a circular economy, the EU should move from a “waste- to a resource-oriented thinking.” Cefic provides that this will require: (1) removing uncertainties related to the end-of-waste statute which suffers from a non-harmonized interpretation at Member State level; (2) improving by-products concepts and the definition of waste; and (3) removing barriers in product legislation prohibiting certain material streams and by-products from further use.

On the fourth and final issue of “difficulties in applying EU waste classification methodologies and impacts on recyclability of materials,” Cefic is of the opinion that a risk-based approach could aid in transitioning towards a circular economy.

European Ombudsman Rejects NGO Complaint On Cosmetics Animal Testing: On July 21, 2017, the European Ombudsman dismissed a complaint by an animal rights non-governmental organization (NGO), People for the Ethical Treatment of Animals (PETA), which argued that the EC’s approach towards animal testing for cosmetic products is misleading. The case concerned a joint statement in October 2014 by the European Chemicals Agency (ECHA) and the EC “clarifying their understanding of the relationship between the Cosmetics Regulation, which bans animal testing, and the REACH Regulation, which allows animal testing of chemicals in certain limited circumstances to assess risks to human health and the environment.”

The October 2014 statement provides that:

  • Registrants of substances that are exclusively used in cosmetics may not perform animal testing to meet the information requirements of the REACH human health endpoints, with the exception of tests that are done to assess the risks to workers exposed to the substance.

  • Registrants of substances that are used for a number of purposes, and not solely in cosmetics, are permitted to perform animal testing, as a last resort, for all human health endpoints.

  • Registrants are permitted to perform animal testing, as a last resort, for all environmental endpoints.

PETA suggested that the joint statement was “contrary to EU law and to the Cosmetics Regulation in particular,” and wanted ECHA and the EC to withdraw the statement. In support of this view, PETA referred to a judgment of the European Court of Justice, delivered after it had made its complaint to the Ombudsman, which addresses the interpretation of the Cosmetics Regulation’s ban on animal testing. PETA argued that the EC and ECHA did not have the legal right to issue the October 2014 statement, and suggested that the joint statement would result in certain cosmetics being incorrectly labeled as “free from animal testing.” ECHA and the EC refused to withdraw the joint statement, and the case was brought by PETA to the Ombudsman.

The Ombudsman inquired into the issue, and decided that it is “not necessary for her to take any view on the proper meaning of the Court judgment in order to resolve this case.” The Ombudsman provided that this is because the joint statement is concerned only with “how the REACH Regulation is interpreted and applied in the light of the Cosmetics Regulation.” The Ombudsman indicated that the joint statement does not “purport to deal” with the interpretation and application of the Cosmetics Regulation in light of REACH. The Ombudsman concluded, therefore, that the “joint statement is not contrary to the Cosmetics Regulation or to EU law more generally.”

The Ombudsman found that the EC and ECHA both had a right to issue the October 2014 joint statement because both have responsibility under REACH. Lastly, the Ombudsman found that no clarifications of the joint statement are needed concerning the labelling of cosmetics as that issue “falls under the Cosmetics Regulation, and not under the REACH Regulation.” In consideration of the above, the Ombudsman concluded that there was no “maladministration” by ECHA or the EC.

Following the decision, PETA has urged the EC and Member States to publish guidance on how the animal testing ban on cosmetics should be interpreted and applied.

Draft Regulation Would Add CMR Substances To REACH Annex XVII: On July 28, 2017, the EC notified the World Trade Organization (WTO) of a draft regulation that would include within the scope of entries 28 to 30 of Annex XVII to the REACH regulation a list of substances with the effect of restricting their placing on the market or use for supply to the general public as substances on their own, as constituents of other substances, or in mixtures. The draft regulation would impose the requirement to mark packaging with the label “restricted to professional users.” The EC drafted the regulation consequent to the recent classification of these substances as carcinogenic, mutagenic, or toxic to reproduction (CMR) category 1A or 1B.

ECHA Consults On Authorization Applications For Chromates: On August 16, 2017, ECHA commenced public consultations on the following authorization applications for chromates:

  • Wesco Aircraft EMEA LTD.’s application for use of Dichromium tris(chromate) for chemical conversion coating applications by aerospace and defense companies and their associated supply chains;

  • The joint application by Wesco EMEA LTD., PPG Central (UK) Ltd. as Only Representative (OR) on behalf of PRC DeSoto International Inc., and Cytec Engineered Materials as OR on behalf of Cytec Industries Inc. for use of Strontium chromate in primers applied by aerospace and defense companies and their associated supply chains;

  • Aviall Services Inc and Finalin GmbH’s application for use of Pentazinc chromate octahydroxide in the formulation of mixtures;

  • The application by Aviall Services Inc and Finalin GmbH for use of Pentazinc chromate octahydroxide in wash primer, fuel tank primer, and aluminized primer for the purpose of corrosion protection in aeronautic applications;

  • ZF Friedrichshafen AG’s application for use of Chromium trioxide in functional chrome plating of piston rods for automotive and rail applications; and

  • Microbeads AS’ application for use of 1,2-dichloroethane in industrial use as a swelling agent during the sulfonation reaction of crosslinked polystyrene beads in the manufacture of ion exchange resins for purification of radioactive waste.

Comments on the authorization applications are “welcomed from the EU and beyond.” The consultations close on October 11, 2017. Further information is available via ECHA’s “Applications for [authorization] - current consultations” webpage.

ECHA Publishes Q&A To Help Downstream Users Of Chromium VI Compounds: ECHA published questions and answers (Q&A) on August 23, 2017, intended to clarify the legal obligations for downstream users of chromium VI compounds after the September 21, 2017, sunset date. ECHA states that downstream users can continue using chromium VI compounds after the sunset of the substance even if the EC has not decided whether to grant an authorization. This continuation is possible if a company up its supply chain has applied for an authorization for their use before the latest application date, which was March 21, 2016. As long as the authorization is pending, the downstream users do not need to take any extra steps. Once the EC has made its decision, and if it grants an authorization, downstream users will need to notify their use to ECHA. More information is available in ECHA’s press release, “Sunset date for Chromium VI compounds approaches -- what should downstream users do?

EP Committee Approves Draft Legislation Targeting Carcinogens And Mutagens In The Workplace: The European Parliament (EP) Committee on Employment and Social Affairs approved draft legislation on August 30, 2017, that would eliminate and reduce carcinogens and mutagens in the workplace. According to the press release, employers will have to assess the risk of exposure for workers and take preventive measures, and this “should tackle the primary cause of work-related deaths in the EU, i.e. cancer.” The legislation is intended to help save up to 100,000 lives over the next 50 years. The press release states that the legislation will lower the occupational exposure limits (OEL) for:

  • Chromium VI, used in textile dyes, paints, and leather tanning materials and generated during the casting, welding, or cutting of stainless steel;

  • Hardwood dust, produced, for instance, by cutting or pulverizing wood; and

  • Vinyl chloride monomer, mainly used to produce polyvinyl chloride (PVC).

The press release states that the Committee ensured that the EC will have to assess the possibility of including reprotoxic substances by the first quarter of 2019. The EP will vote on the draft legislation during a forthcoming plenary.

EC Adds CMRs To REACH Annex XVII: The EC published an amendment to REACH Annex XVII in the August 31, 2017, Official Journal of the European Union. The amendment adds more than 20 substances recently classified as CMR category 1A or 1B to Annex XVII, substances restricted under REACH. The substances added by the amendment are different than the ones in the July 28, 2017, WTO notification reported above.

Report Indicates Companies Lack Incentives For Updating REACH Registrations: On September 4, 2017, ECHA issued a press release entitled “Study finds companies lack incentives for updating their REACH registrations.” The study was carried out by Amec Foster Wheeler and Peter Fisk Associates, and does not represent the views or position of ECHA. It is part of “ECHA’s efforts to [maximize] the availability of high quality data to enable the safe manufacture and use of chemicals.”

The report examines the challenges and incentives for updating REACH and CLP dossiers and identifies best practices that could help companies improve their data. The report indicates that the main issues affecting companies responsible for updating their information are: (1) the perception that registration is the end of the process and that no additional work is needed afterwards; (2) “obscurity of what needs to be updated, when and by whom”; and (3) limited resources, particularly for Small- and Medium-sized Enterprises (SME).

The methodology adopted for the report included a “questionnaire survey” and “interview phase.” The report describes the methodology and outcomes, conclusions, and recommendations. The report’s findings included that respondents perceived the REACH Article 22 requirements related to updating registrations “without undue delay” to be vague, and that “64 [percent] of the registrations submitted since 2008 have never been updated.” Respondents highlighted that REACH is based on the One Substance, One Registration principle, and that many registrations have been completed within Substance Information Exchange Forums (SIEF). Respondents suggested that this scenario “makes it ambiguous as to whom is responsible” (i.e., Lead Registrant, all SIEF members, individual).

The report proposes improvements structured around the following four steps:

  • A clear definition of what needs to be updated;

  • A clear definition of who is responsible for the updates -- “clarifying the roles of the lead and co-registrants”;

  • An improved understanding of why updates are important -- that they have an impact on protecting human health and the environment; and

  • An Implementing Act to clarify the update requirement of REACH Article 22, including clear circumstances and fixed intervals for when dossiers need to be updated.

The recommended actions are addressed to ECHA, trade associations, and policymakers. The report has been “sent to the [EC] for their consideration under the REACH Review expected to be [finalized] by the end of the year.” More information is available in the full report, “A study to gather insights on the drivers, barriers, costs and benefits for updating REACH registration and CLP notification dossiers.”

EC Officially Adopts EDC Identification Criteria For BPR: On September 4, 2017, the EC issued a press release entitled “Endocrine disruptors: adoption of scientific criteria for biocides.” The EC’s press release stated that following endorsement by Member States, on July 4, 2017, of the scientific criteria for identification of EDCs in pesticides, the EC adopted on September 4, 2017, the scientific criteria for identification of EDCs under the Biocidal Products Regulation (BPR). The EC’s press release provides that “[t]his will allow to fully align the criteria in both legislations, as the objective is to have the same criteria applicable in both sectors.”

The official adoption by the EC of the criteria for identification of EDCs in biocides follows the July 12, 2017, vote by EU competent authorities for the adoption of a regulation that would incorporate the criteria into the BPR. The next step towards official entry into force of the criteria is discussion by the EP’s Committee on Environment, Public Heath and Food Safety (ENVI) on September 28, 2017. ENVI does not have the power to amend the proposed criteria, however, it can reject the criteria and require the EC to revisit its proposal. If ENVI approves of the proposed criteria, a vote on the criteria will occur in a plenary session of the EP.

Further information is available in the Commission Regulation on EDC Criteria under the BPR, and the related Annex.

ECHA Consults On Proposals To Identify Nine New SVHCs: On September 5, 2017, ECHA issued a press release entitled “Public consultation to identify nine new substances of very high concern.” As described in ECHA’s press release and its public consultation, ECHA invites comments related to the potential identification of the following substances as substances of very high concern (SVHC) for the related uses by October 20, 2017:

  • 4,4’-isopropylidenediphenol (BPA): Used in the manufacture of polycarbonate, as a hardener for epoxy resins, as an anti-oxidant for processing PVC, and in the production of thermal paper. BPA is already included in the Candidate List due to its toxic for reproduction properties and its endocrine disrupting properties with effects on human health;

  • Chrysene: Not registered under REACH. Normally not produced intentionally, but rather occurs as a constituent or impurity in other substances;

  • Benz[a]anthracene: Not registered under REACH. Normally not produced intentionally, but rather occurs as a constituent or impurity in other substances;

  • Cadmium nitrate: Used in laboratory chemicals and for the manufacture of glass, porcelain, and ceramic products;

  • Cadmium hydroxide: Used in laboratory chemicals and for the manufacture of electrical, electronic, and optical equipment;

  • Cadmium carbonate: Used as a pH regulator and in water treatment products, laboratory chemicals, cosmetics, and personal care products;

  • Tricobalt tetraoxide containing ≥ 0.1 percent w/w nickel oxides: Used in laboratory chemicals, pH regulators, and in water treatment products, semiconductors, polymers, and coating products;

  • Dechlorane plus (including any of its individual anti- and syn-isomers or any combination thereof): Used as a non-plasticizing flame retardant, used in adhesives and sealants, and in binding agents; and

  • Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde, and 4-heptylphenol, branched and linear (RP-HP) [with ≥0.1 percent w/w 4-heptylphenol, branched and linear]: Used as a lubricant additive in lubricants and greases.

ECHA Issues Report On PIC Regulation: On September 6, 2017, ECHA issued a press release entitled “Increase in notifications providing information on the export of hazardous chemicals.” In the press release, ECHA states that its “first report on the operation of the Prior Informed Consent (PIC) Regulation shows that notifications from EU companies to export certain hazardous chemicals outside the EU have grown by 74 [percent] in the past three years.”

ECHA’s report, which “looks back on the first three years of implementing the PIC Regulation (2014-2016),” indicates that awareness of and compliance with the PIC Regulation has grown significantly. The report indicates that annual export notifications increased by 74 percent between 2014 and 2016, from 4,500 in 2014 to nearly 8,000 in 2016. ECHA states that this increase is far beyond the originally estimated ten percent yearly increase. In its press release, ECHA states that “[t]he large number of notifications also implies that the EU gives an increasing amount of useful information to authorities in importing countries, which they can use for regulatory purposes and to identify the companies using these chemicals in their country.”

ECHA stated that the number of companies involved in PIC activities has increased from 390 to 1,177, partly due to new chemicals added to the list of chemicals subject to an export notification, and partly due to ECHA’s “activity in raising awareness of the regulation.”

ECHA’s report suggests methods for improving cooperation with the EC on topics such as distributing or reallocating certain tasks, planning workloads, and managing amendments to the PIC Regulation. The report also proposes potential changes to the legal text of the PIC Regulation to “improve or resolve some of the workability issues that [ECHA] has faced.” ECHA seeks to discuss these points with the EC and Member States.

Biocides Stakeholders’ Day Will Be Held In September 2017: On September 26-27, 2017, ECHA will hold Biocides Stakeholders’ Day 2017. The conference will provide stakeholders the latest information on the BPR and the tools and support available. The focus will be on experiences from companies, EU Member States, ECHA, and the EC. Participants will have an opportunity to book a one-to-one meeting with ECHA’s experts and take part in training on the biocides IT tools (IUCLID, R4BP 3, and SPC Editor). Participation is free of charge. ECHA will web-stream the conference live on September 26, 2017. ECHA states that it will post the link on its home page on the day of the event.

ECHA Will Hold Stock-Taking Conference On Applications For Authorization: On November 14, 2017, ECHA will hold a Stock-Taking Conference on Applications for Authorization. ECHA states that the purpose of the conference is to take stock of the evolution and achievements of the authorization process in terms of substitution, risk reduction, and cost-effectiveness. Furthermore, it will provide a forum for all involved to discuss points for improvement in the process. ECHA intends the conference to increase confidence and understanding of the application of the authorization process over the years to come.

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The Acta Group (Acta®) is the consulting affiliate of Bergeson & Campbell, P.C. (B&C®), established to complement B&C’s legal services by providing a full-range of support for the process of marketing chemicals, biocides, and products of industrial biotechnology, nanotechnology, and synthetic biology. Acta knows that clients must function optimally in all jurisdictions in which they market and/or place products to remain competitive. We help them get there through our global reach....