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September 14, 2017

Cefic Provides Circular Economy Comments On EC’s Stakeholder Consultation, and Other Recent REACH Developments

The ACTA Group

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 European Union (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 [Registration, Evaluation, Authorization and Restriction of Chemicals (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.
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.”
KEMI Identifies 37 Bisphenols As Potential EDCs: Kemikalieinspektionen (KEMI), the Swedish Chemicals Agency, issued a press release and report, in Swedish, to indicate that its investigation has found that 37 of 39 bisphenols surveyed on the European market could have potential endocrine disrupting properties. KEMI adopted a screening method that groups substances based on their chemical structure, possible use in different applications, and potential endocrine disrupting properties according to data simulations.
Following imposition of EU-wide restrictions on BPA, KEMI indicates in its press release that over 200 chemical substances have a similar chemical structure to BPA. KEMI states that 37 of these substances may have hormone-disrupting properties similar to those of BPA, and that these substances may be used in a manner that could lead to consumers being exposed. KEMI further observes that the following six substances have health characteristics and usage patterns that present challenges from a risk perspective:

  • BPA;
  • Bisphenol F;
  • Bisphenol M;
  • Bisphenol S;
  • 2,2-bis(4´-hydroxyphenyl)-4-methylpentane; and
  • Benzophenone-2.

Risk Management Option Analyses have been initiated under REACH for these six substances, and Bisphenol AF and Tertramethyl Bisphenol F. KEMI states that as the six substances are currently being handled under REACH, it does not propose new national restrictive rules for use of the substances in Sweden.
KEMI indicates that information on the toxicological effects of half of the 39 analyzed substances is inadequate or entirely missing, and that this is problematic because, according to data simulations, all bisphenols selected for the survey can have endocrine disrupting properties similar to BPA.
KEMI found that there is reason to continue reviewing the group of bisphenols, and indicated that it should actively disseminate results to researchers and other authorities. KEMI will also inform affected companies and industries in Sweden of results, and if needed, initiate dialogue with the companies.
Turkey REACH Documents Available In English: As reported in our Global Regulatory Update for August 2017, on June 23, 2017, Turkey’s Ministry of Environment and Urbanization (MoEU) published its REACH-like KKDIK Regulation. As reported in The Acta Group’s memorandum entitled “Turkey Catching Up with the [EU’s REACH] Regulation,” the name “KKDIK” is derived from the first letters of “Registration,” “Evaluation,” “Authorization,” and “Restriction” in Turkish. Similar to EU REACH, KKDIK requires companies to register substances manufactured in Turkey or imported into Turkey in quantities of greater than one metric ton per annum within prescribed deadlines. Turkey recently posted English translations of several Turkey REACH documents on its website:

Brexit Moves Forward, Government Issues Papers, And CIA Provides Comments: As the EU Withdrawal Bill, formerly referred to as the Great Repeal Bill, won its Commons vote by 326 to 290, despite critics warning that it presented a “power grab” by ministers, the United Kingdom (UK) took a significant step towards ending the supremacy of EU law in the UK on September 12, 2017. Prime Minister Theresa May welcomed the Commons vote, stating the Bill offered “certainty and clarity.” The EU Withdrawal Bill overturns the European Communities Act 1972 and will convert existing EU laws into UK law to ensure there are no gaps in legislation on Brexit day. The Bill will now receive line-by-line scrutiny in its committee stage. UK Members of Parliament (MP) voted in favor of the Government’s proposed timetable for debating the legislation — by 318 votes to 301 — guaranteeing 64 hours of debate over eight days. The Bill’s committee stage will commence when MPs return to Parliament after their party conferences.
In July, the UK’s Environment Minister Thérèse Coffey, Ph.D. stated that the UK intends to secure a “mutual recognition” agreement on chemicals policy with the EU prior to Brexit, indicating that regulatory equivalence was a priority for the UK. Dr. Coffey stated in July that it would be in the interests of the UK and the EU to recognize validity of pre-Brexit REACH registrations submitted by UK entities following Brexit, particularly considering that the REACH registration process is complex and UK companies have already invested heavily in it. Subsequently, the UK Government issued a position paper entitled “Continuity in the availability of goods for the EU and the UK.”
The Government’s position paper provides under “Principle B: Where businesses have undertaken compliance activities prior to exit, they should not be required to duplicate these activities” that businesses “will have undertaken a number of complex, lengthy and often costly procedures” to place goods on the EU market. The position paper states “[t]his could include, for example, undergoing an inspection by an [EU-recognized] body to ensure production is in accordance with Good Manufacturing Practice or collecting and submitting data on the hazards and risks of a chemical substance … The Withdrawal Agreement should [recognize] the validity of this compliance activity where it has taken place prior to exit. This should be [recognized] for both the UK and EU markets regardless of where the activity took place, and it should be [recognized] for the full time period or type of products intended when the compliance activity was undertaken.”
In response to the Government’s position paper, the UK’s Chemical Industries Association (CIA) issued a press release entitled “Chemical industry supports Government’s approach on goods availability.” In the press release, Steve Elliott, Chief Executive of CIA, stated: “I think the Government is taking exactly the right approach in this area, acknowledging the need for chemical businesses to be reassured that significant regulatory commitments and related costs, such as those already undertaken under REACH, will remain valid after exit from the EU. The approach outlined by [the] Government confirms where businesses have undertaken compliance activities prior to exit, they should not be required to duplicate these activities in order to place goods on the UK and the EU market after exit. This includes [recognizing] the validity of type approvals, certificates and registrations issued prior to exit … Accepting the ongoing validity of all pre-departure registration activities marks a significant step in securing that outcome.”

The UK Government also issued a “future partnership paper” entitled “Future customs arrangements” prior to the aforementioned position paper. CIA criticized this customs paper in its press release, “Government making transition too complicated says top manufacturing exporter,” on the grounds that an interim Customs Union following Brexit could bring uncertainty. CIA suggested that the UK Government is “making the full transition to Brexit unnecessarily complex,” and that the UK’s chemicals industry is affected significantly by this.

CIA recently indicated that it supports the UK remaining “in” all REACH processes following Brexit, including Authorization and Restriction. CIA provides that there are strong commercial interests, in addition to environmental health and safety concerns, that drive its view.