Global Regulatory Update for September 2017


CANADA

Canada Publishes Results Of Prioritization Of The Revised In Commerce List: On August 10, 2017, Canada published the results of its prioritization of the Revised In Commerce List (R-ICL) with supporting rationale. Substances on the R-ICL include substances in pharmaceuticals, veterinary drugs, cosmetics, biologics, food products, natural health products, and medical devices. Under the Chemicals Management Plan (CMP), Health Canada prioritized substances on the R-ICL to identify those that require further evaluation to determine whether they pose a risk to human health or the environment. Health Canada applied the prioritization process to approximately 3,500 substances to separate those that are unlikely to require further work based on information available at the time from those that represent priorities for risk assessment or that require further information. Approximately 25 percent of the substances were prioritized for further evaluation, while the remaining 75 percent were of reduced priority in the context of the R-ICL. Canada notes that reduced priority does not preclude actions being taken under other Canadian Environmental Protection Act (CEPA) initiatives. Reduced priority substances that are on the Domestic Substances List (DSL) have been deleted from the R-ICL.

Canada Publishes Information Received In Response To Several Section 71 Surveys: On August 29, 2017, Canada published information received in response to certain notices published in the Canada Gazette under CEPA Section 71 targeting chemical substances of interest under the CMP. Canada states that some information gathered was considered confidential business information (CBI) by submitters, and Canada masked the CBI prior to publication. Canada notes that these documents do not include an assessment of the potential risks these substances may represent for the environment or the health of Canadians.

CHINA

China Amends Data Requirements For New Chemical Notification: On August 31, 2017, the Ministry of Environmental Protection (MEP) published the Amendment on Data Requirements for China New Chemical Notification. The Amendment will take effect October 15, 2017. The Amendment on Data Requirements includes the following five tables:

  • Table 1. Minimum requirements of toxicological data;
     
  • Table 2. Minimum requirements of eco-toxicological data;
     
  • Table 3. Exemption conditions of physico-chemical data;
     
  • Table 4. Exemption conditions of toxicology testing data; and
     
  • Table 5. Exemption conditions of eco-toxicology testing data.
     

The China Solid Waste and Chemical Management Center (SCC) will conduct training on the Amendment on September 25-27, 2017. More information on the Amendment is available in our memorandum, “Revised Data Requirements for China New Chemical Notification Released.”

DENMARK

Testing Identifies Suspected EDCs In Pushchairs: On August 3, 2017, the Danish Consumer Council’s THINK Chemicals initiative issued a press release entitled “Pushchairs: These problematic chemicals were found in test.” The press release states that 11 pushchairs were tested for unwanted chemicals in the seat and handle by THINK Chemicals. THINK Chemicals states that “[‌i]n the test [four] pushchairs receive the best assessment. The pushchair Britax B-motion 4 plus performs best in the test … [Three] other pushchairs also receive top marks. In these products only very small amounts of so-called [polycyclic aromatic hydrocarbons (PAH)] were present in the handle.”

THINK Chemicals stated that six pushchairs, identified below, received the lowest mark on the test because of the content of “problematic substances” such as chlorinated paraffins, the flame retardant Tris (1-chloro-2-propyl) phosphate (TCPP), or a “PAH called naphthalene.” These substances were found in the handles or seat. THINK Chemicals indicated that the aforementioned problematic chemicals are not banned in baby products, however, naphthalene is classified as possibly carcinogenic. THINK Chemicals provided that chlorinated paraffins are on the Danish Environmental Protection Agency’s list of “unwanted substances” and are suspected endocrine disrupting chemicals (EDC). THINK Chemicals indicates that TCPP is banned in the European Union (EU) in toys for children from zero to three years old because it “can be carcinogenic.”

THINK Chemicals stated that for the reasons identified above, the substances are “problematic in baby products such as pushchairs.” THINK Chemicals states that exposure in a single product is not necessarily problematic in itself, but such exposure contributes to children’s combined exposure to unwanted chemicals from many different sources. THINK Chemicals stated that it is a “good idea to minimize the exposure when possible -- especially in baby products.”

Britax B Motion 4 Plus, Baby Jogger City Premier, Basson Baby Uno, and Joie Litetrax 4 received the “best assessment (A)” from THINK Chemicals. Hauck Rapid 4 received a “middle assessment (B),” and Britax Smile 2, Cybex Balios M, Gb QBIT Plus, Maxi Cosi Stella, Mutsy Nexo, and Phil and Teds Smart received the “lowest assessment (C).”

THINK Chemicals’ test also researched content of unwanted phthalates in the pushchairs, and no phthalates were found in the 11 tested products. More information is available, in Danish, in the “full test with product pictures.”

EU

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.

SWEDEN

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

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:

Turkey Introduces New Controls On Restricted Chemicals In Footwear: Turkey has announced customs controls on restricted substances in imported footwear. The restrictions were passed in 2015, and entered into force on July 10, 2017. The restrictions concern Chromium VI, Dioctyltin, and the phthalates Benzyl Butyl Phthalate (BBP), Dibutyl Phthalate (DBP), Bis(2-ethylhexyl) Phthalate (DEHP), Diisodecyl Phthalate (DIDP), Diisononyl Phthalate (DINP), and Di-n-octylphthalate (DNOP).

The restrictions include:

  • Chromium VI in accessible leather parts is limited to 3 mg/kg;
     
  • Dioctyltin in footwear or its components, intended to come into skin contact, has a concentration limit of 0.1 percent (weight by weight); and
     
  • The relevant phthalates in accessible and inaccessible parts have a concentration limit of 0.1 percent.
     

Additional information is available, in Turkish, in the Restrictions List.

UNITED KINGDOM (UK)

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 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.


 
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