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January 1, 2017

Global Regulatory Update for January 2017

The ACTA Group

Acta® Will Present Deeper Dive On Chemical Substance Regulation In Central And South America: The Acta Group (Acta) is pleased to offer our clients, associated businesses, and corporate product stewards and regulatory personnel a follow-up to our November 2016 webinar “Current Opportunities and Challenges with Chemical Substance Regulation in Mexico and Central and South America.” This second webinar, “Chemical Substance Regulation in Central and South America: A Deeper Dive,” will examine the chemical substance regulations of several additional countries in the region, whose regulatory environments are generally not well-known or understood. Exploring the requirements of Chile, Colombia, Costa Rica, Ecuador, Honduras, Uruguay, and Venezuela, the webinar will present a comprehensive overview of the key requirements firms should be aware of when manufacturing or importing chemical substances. Among the topics will be the status of Globally Harmonized System of Classification and Labeling (GHS) implementation, the development of chemical substance inventories, product stewardship efforts, key worker and workplace safety regulations, and related issues such as pesticide, packaging, and food contact legislation.

The 1-hour webinar will conclude with a discussion of key emerging issues in the region for both 2017 and beyond. The webinar, moderated by Lynn L. Bergeson, President, Acta, and presented by Michael S. Wenk, M.S., Senior Regulatory Consultant with Acta, will consist of 45 minutes of presentation with a 15-minute question and answer period at the end.


Canada Publishes Technical Guidance On HPA And HPR Requirements: In December 2016, Health Canada published Technical Guidance on the Requirements of the Hazardous Products Act (HPA) and the Hazardous Products Regulations (HPR) — WHMIS 2015 Supplier Requirements. Health Canada states that the purpose of the document is to provide guidance on the requirements of HPA and HPR to suppliers of hazardous products destined for Canadian workplaces. The document also provides suppliers with information on the Hazardous Materials Information Review Act (HMIRA) and its regulations and the mechanism to protect confidential business information (CBI).

PMRA Reviews Data Protection Program For Pesticides: The Pest Management Regulatory Agency (PMRA) has released for comment a proposed Agreement for Data Protection under Section 66 of the Pest Control Products Act (currently called the Ministerial Agreement for Data Protection under the Pest Control Products Act) and the proposed Eligibility Criteria for Compensable Protection Status for Foreign Test Data. PMRA previously requested advice from a neutral third party consultant on whether its pesticide data protection system achieves the right balance between encouraging the registration of new innovative products and generic pesticides. In November 2014, PMRA received the final report and sent it to stakeholders. According to PMRA, the report indicated that most stakeholder representatives from among grower groups, innovative companies, and generics companies supported the overall approach and design of the data protection program, and saw no need for a fundamental re-design. At the same time, PMRA states, many stakeholders noted that the current design and delivery of a number of key process elements were limiting the timeliness and predictability of the data protection program, and inhibiting the rate at which companies were seeking to register generic products. PMRA addressed many of the recommendations regarding the application process, including timeliness, through the revised process set out in the Memorandum to Applicants and Registrants: Data Protection Submission Review Process. PMRA states that the proposed documents for the consultation are intended to address the recommendations for changes to the arbitration process and to clarify foreign test data eligibility criteria. Comments are due February 13, 2017.

Canada Begins DSL Inventory Update: On January 17, 2017, Environment and Climate Change Canada published a notice in the Canada Gazette with respect to substances included as part of the 2017 Domestic Substances List (DSL) Inventory update. Persons required to provide information include:

  • Any person who, during the 2014 or 2015 calendar year, manufactured a total quantity greater than 100 kilograms (kg) of a substance listed in Part 1, Part 2, or Part 3 of Schedule 1 to this notice;
  • Any person who, during the 2014 or 2015 calendar year, manufactured a total quantity greater than 100 kg of a substance listed in Part 4 of Schedule 1 to this notice that is a cosmetic, food, therapeutic product or natural health product subject to the Food and Drugs Act or is intended to be a component in such products;
  • Any person who, during the 2014 or 2015 calendar year, imported a total quantity greater than 100 kg of a substance listed in Part 1, Part 2, or Part 3 of Schedule 1 to this notice, whether the substance is:
    1. Alone;
    2. At a concentration equal to or above 0.1 percent by weight (w/w%) in a mixture or in a product; or
    3. Listed in Part 3 of Schedule 1 and at a concentration equal to or above 0.1 percent by weight (w/w%) in a manufactured item that is:
      1. Intended to be used by or for children under the age of six years;
      2. Intended to come into contact with the mucosa of an individual, other than eyes;
      3. Cookware, or a cooking or serving utensil that is intended to come into direct contact with heated food within a residence, unless the component that comes into direct contact with heated food is made of glass, stainless steel, or porcelain;
      4. Food packaging that is intended to come into direct contact with food, unless the component that comes into direct contact with food is made of glass, stainless steel, or porcelain;
      5. A reusable food or beverage container, unless the component that comes into direct contact with food or beverage is made of glass, stainless steel or porcelain;
      6. Intended to release the substance during conditions of use such that the substance may be inhaled or come into dermal contact with an individual;
      7. Clothing or footwear,
      8. Bedding, a sleeping bag, or a towel,
      9. Furniture, a mattress, a cushion, or a pillow intended to be used in a residence, where the substance is contained in foam or leather or in a textile fiber, yarn, or fabric, or
      10. Carpet, vinyl, or laminate flooring, or foam underlay for flooring, intended to be used in a residence.
  • Any person who, during the 2014 or 2015 calendar year, imported a total quantity greater than 100 kg of a substance, listed in Part 4 of Schedule 1 to this notice, that is, is contained in, or is intended to be a component in, a cosmetic, food, therapeutic product or natural health product subject to the Food and Drugs Act; and
  • Any person for whom the criteria set out in Schedule 2 have been met for both the 2014 and 2015 calendar years shall provide information prescribed in Sections 6 to 10 of Schedule 3 to this notice for the 2015 calendar year only.

The notice does not apply to a substance listed in Schedule 1, whether alone, in a mixture, in a product, or in a manufactured item, that:

  • Is in transit through Canada;
  • Is tin fluoride (Chemical Abstracts Service (CAS) Number 7783-47-3) contained in dental care products or mixtures;
  • Is, or is contained in, a hazardous waste or hazardous recyclable material within the meaning of the Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations and was imported pursuant to a permit issued under these Regulations;
  • Is, or is contained in, a pest control product registered under the Pest Control Products Act;
  • Is, or is contained in, a fertilizer or supplement registered under the Fertilizers Act;
  • Is, or is contained in, a feed registered under the Feeds Act; or
  • Is mixed with, or attached to, a seed registered under the Seeds Act.

If a person provided information under the New Substances Notification Regulations for a substance listed in Part 4 of Schedule 1, a response from that person is not required for that substance. Responses are due July 17, 2017, no later than 3:00 p.m. EDT.


Colombia Publishes Draft Regulation Adopting GHS: The Colombian Ministry of Labor and Social Security has published a Draft Decree that proposes to implement the GHS in the country. The Draft Decree will incorporate the 6th Edition of the United Nations (UN) GHS (“Purple Book”), and would require that when future iterations of the GHS regulation are published, multiple Ministries (Transport, Commerce, Agriculture, Labor and Health) would have six months to review the revised System and incorporate any changes into National law. The Draft Decree is perhaps predictably comprehensive in its scope, following in the footsteps of several other South American countries (e.g., Argentina, Brazil) that have implemented the System in recent years. As proposed, there are no exemptions for either public or private entities, and the Draft Decree does not distinguish between hazardous and non-hazardous substances (pure form, mixtures, or solutions). Any entity that produces, imports, stores, distributes and/or sell chemical substances must evaluate their substances and classify them accordingly. There is presently no defined adoption date for the final Decree.


SCHEER Will Develop Scientific Opinion On Aluminum Migration Limits For Toys: The European Commission’s (EC) Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) will develop a scientific opinion on the tolerable intake of aluminum “with regards to adapting the [migration limits for toys].” This measure is in response to the European Food Safety Authority (EFSA) and the Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Committee of Food Additives (JECFA) establishing lower tolerable intake levels for aluminum than those used in the Toy Safety Directive.

SCHEER has been requested:

  • To review currently available data on the toxicity of aluminum, taking into account the different tolerable intake levels for aluminum established by EFSA in 2008 and JECFA in 2011; and
  • To advise on a tolerable intake level for aluminum based on most recent data that could be used to adapt the migration limits for aluminum in the Toy Safety Directive, taking into account the exposure to aluminum from sources other than toys.

SCHEER is expected to provide a preliminary opinion in May 2017 and a final opinion in Autumn 2017. More information is available in the “Request for a scientific opinion on the tolerable intake of [aluminum] with regards to adapting the migration limits for [aluminum] in toys.”

ECHA Article Indicates Certain Chemicals May Not Require Acute Oral Toxicity Tests For REACH Registration: A European Chemicals Agency (ECHA) research article entitled “Alternative acute oral toxicity assessment under [the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation] based on sub-acute toxicity values” provides that chemicals showing low oral toxicity in sub-acute tests may not require additional acute oral tests. The research article states “[REACH] requires information on acute oral toxicity for substances produced or imported in quantities greater than one tonne per year. When registering, animal testing should be used as [a] last resort. The standard acute oral toxicity test requires use of animals. Therefore, [ECHA] examined whether alternative ways exist to generate information on acute oral toxicity.”

ECHA estimates that REACH registrants of approximately 550 substances will be able to omit in vivo acute oral studies “[ahead] of the last REACH registration deadline in 2018.” While REACH requires data for this endpoint, ECHA has recommended that registrants use results from a 28-day oral toxicity study as part of a weight-of-evidence approach for covering acute toxicity. ECHA conducted an analysis of the REACH database and found suitable studies on both acute oral and sub-acute oral toxicities for 1,256 substances. Four hundred and fifteen of these substances had low toxicity in the sub-acute toxicity study, and for 98 percent of these substances, low acute oral toxicity was also reported.

The results of the research article support the hypothesis that low acute oral toxicity can be predicted from the results of low toxicity in oral sub-acute toxicity studies. ECHA provides that registrants that wish to use information from such studies in their REACH registration dossier need to report findings as part of a weight-of-evidence approach, and that cytotoxicity tests, physico-chemical information, and quantitative structure-activity relationships (QSAR) will also be required.

BoA Dismisses Appeal Against ECHA’s Octocrilene Decision: On December 7, 2016, ECHA’s Board of Appeal (BoA) dismissed an appeal against a substance evaluation decision for octocrilene, a substance used in cosmetics and other consumer products.

BASF SE lodged the appeal on December 10, 2014, requesting BoA to annul the Contested Decision in entirety because of a violation of essential procedural requirements and breaches of the principles of legal certainty and equal treatment. Alternatively, BASF SE requested that if BoA does not annul the Contested Decision in its entirety, BoA should annul or amend the Contested Decision insofar as it requires BASF SE to submit information related to bioaccumulation tests and conduct an Androgenized Female Stickleback Screen Study.

BASF SE raised several pleas that were divided into two groups for examination by BoA. The first group of pleas related to who the Contested Decision was, and should have been, addressed to. The second group of pleas related to the information requirements of the Contested Decision.

ECHA’s BoA dismissed the appeal in its entirety, decided that the information requested in the Contested Decision should be provided to ECHA by December 26, 2018, and decided that the appeal fee will not be refunded. More information is available in ECHA’s press release, “[BoA] publishes a decision on an appeal against a substance evaluation decision for octocrilene.”

EC Adopts BPA Restriction In Thermal Paper: On December 13, 2016, Commission Regulation (EU) 2016/2235 was published in the Official Journal of the EU. The Regulation adds Bisphenol A (BPA) to REACH Annex XVII. The entry in REACH Annex XVII states “[BPA shall] not be placed on the market in thermal paper in a concentration equal to or greater than [0.02 percent by weight after January 2, 2020].”

Regulation (EU) 2016/2235 refers to submission by France of a dossier to ECHA pursuant to REACH Article 69(4) and states that the “dossier indicated a risk for workers (primarily cashiers) and consumers exposed to [BPA] by handling thermal paper receipts and proposed a restriction on the placing on the market of BPA in thermal paper in a concentration equal to or greater than [0.02 percent by weight]. More precisely, the population at risk was the unborn children of pregnant workers and consumers exposed to BPA contained in the thermal paper they handle.”

Additionally, Regulation (EU) 2016/2235 outlines the Risk Assessment Committee’s (RAC) and the Socio-economic Analysis Committee’s (SEAC) conclusions on BPA and mentions specifically concerns related to Bisphenol S (BPS), “the most likely substitute according to France.”

EU Legislative Priorities Include Improving Waste Management In A Circular Economy And Building A Forward Looking Climate Change Policy: On December 13, 2016, the Council of the EU approved the EU’s legislative priorities for 2017 as agreed beforehand with the European Parliament (EP) and the EC. The Council states that this “will help the three EU institutions to pool their efforts and to ensure substantial progress in fields where they are most needed.” The legislative initiatives that will receive priority treatment include:

  • Giving a new boost to jobs, growth, and investment through strengthening the European fund for strategic investment, modernizing trade defense instruments, improving waste management in a circular economy, making progress on the banking union, and on the capital markets union;
  • Addressing the social dimension of the EU, in particular through enhancing the youth employment initiative, improving social security coordination, allowing easier access of accessible products and services to the market, and creating a European solidarity corps;
  • Better protecting EU citizens’ security, in particular through better protecting external borders, stronger rules on buying and possessing firearms, fighting terrorism, money laundering, and terrorist financing, and information exchange on third country nationals;
  • Reforming the EU’s migration policy in a spirit of responsibility and solidarity, notably through revising the EU’s asylum rules and enhancing investments in third countries to address the root causes of migration;
  • Delivering on a digital single market, in particular through reforming the EU telecoms and copyright rules, allowing the use of the 700 MHz band for mobile services, preventing unjustified geo-blocking, revising the audiovisual media services directive, and modernising the common data
    protection rules; and
  • Building an energy union and a forward looking climate change policy, notably through the implementation of the 2030 climate and energy framework, the follow-up to the Paris Agreement, and the clean energy for all Europeans package.

ECHA Committees Discuss Glyphosate And Give Opinions On Hexavalent Chromium: ECHA announced on December 13, 2016, that RAC and SEAC adopted 19 final opinions related to applications for authorization. According to ECHA, ten opinions cover five applications submitted by an industrial consortium for the uses of hexavalent chromium compounds by the aerospace and aeronautical sectors. Four opinions are on the uses of hexavalent chromium compounds in chrome plating by the automotive industry. Three opinions cover uses of sodium dichromate by the pulp and paper sector. The remaining two opinions are on functional chrome plating for various industry sectors, and on the electrolytic passivation of tin plated steel for the packaging industry. RAC and SEAC recommended that the industrial consortium application be granted a review period of seven years with specific conditions. ECHA states that the conditions “are considered to be important to reduce the risks of these cancer causing substances.” At its meeting, RAC also held its first preparatory discussion on the harmonized classification and labeling of glyphosate. According to ECHA, RAC will continue discussing glyphosate at its next meeting in March 2017 and the final independent scientific opinion regarding the proposed classification for glyphosate can be expected during 2017.

Draft REACH Guidance Documents For Nanomaterials Move To Next Consultation Step: ECHA announced in its December 14, 2016, ECHA Weekly that the following updated draft REACH guidances have moved to the next consultation step and been sent to the Member State Committee (MSC) for review:

ECHA announced in its December 21, 2016, ECHA Weekly that the guidance on recommendations for nanomaterials applicable to QSARs and grouping of chemicals has moved to the next consultation step and been sent to MSC for review. ECHA suggests that potential registrants for the 2018 deadline may be interested in viewing the revised draft documents. The draft guidance documents were first submitted to Partner Expert Groups (PEG) for consultation. ECHA has posted summaries of the comments received from the PEGs, as well as its responses. The final consultation on the guidance documents will be with the EC and the relevant Competent Authorities.

ClientEarth Taking EC To Court For DEHP Authorization: On December 15, 2016, ClientEarth issued a press release entitled “Commission to face EU judges over toxic plastics approval.” In its press release, ClientEarth states “[the EC] has ignored ClientEarth’s call to stop plastics recyclers using a hormone-harming chemical which causes infertility and developmental problems in children … ClientEarth is now preparing to take the case before the EU Court.”

ClientEarth filed the legal challenge after the EC decided Vinyloop Ferrera, Stena Recycling, and Plastic Planet can use Di(2-ethylhexyl)phthalate (DEHP) until February 2019. ClientEarth Brussels-based lawyer Alice Bernard stated “[w]e are disappointed by the [EC’s] response, because this [authorization] is a huge mistake. It threatens EU citizens and the environment and puts the [authorization] process on the wrong track for cases to come … The [EC’s] approval of DEHP, despite the companies not submitting information required by law — and proof that safe alternatives are available — clearly shows how the chemicals [authorization] process currently works — with scant regard for the law or people’s health.”

ClientEarth suggests that the EC’s authorization of DEHP was based on a “deeply flawed application that was missing key information required by law.” Additionally, ClientEarth states that the EC “ignored proof” that safer alternatives to DEHP were available and approved use of DEHP even though “the plastics recyclers did not show that the benefits to society outweighed the risks.”

ClientEarth filed the “Request for Internal Review under Title IV of the Aarhus Regulation” on August 2, 2016, and the EC replied after requesting additional time to review the arguments. The EC contended in its reply on December 7, 2016, that it had not infringed any of the REACH provisions referred to in ClientEarth’s request for internal review (e.g., Articles 60(7), 60(2), 60(4), and 70).

ClientEarth’s case will be filed before the European Court of Justice (ECJ) in February 2017. This is the first time a non-governmental organization (NGO) has been granted permission to sue the EC for a chemicals approval and ClientEarth suggests this could lead to many more cases in the future.

BPC Adopts 17 Opinions Supporting Approval Of Six Active Substances: At the “18th Meeting of [ECHA’s] Biocidal Products Committee (BPC),” the Committee concluded that the following substances may be approved in the relevant product-types (PT):

  • Peracetic acid generated from tetra-acetylethylenediamine (TAED) and sodium percarbonate for PTs 2, 3, and 4;
  • Active chlorine released from sodium hypochlorite for PTs 1, 2, 3, 4, and 5;
  • Active chlorine released from calcium hypochlorite for PTs 2, 3, 4, and 5;
  • Active chlorine released from chlorine for PTs 2 and 5;
  • Methylisothiazolinone (MIT) for PT 11; and
  • 2-Octyl-2H-isothiazol-3-one (OIT) for PT 8.

The adopted opinions will support the EC and Member States (MS) in deciding on the approval of these active substances. An opinion of non-approval was adopted by BPC for 2-Methyl-1,2-Benzisothiazol-3(2H)-one (MBIT) for PT 13. The reason for non-approval was that there are unacceptable risks identified for groundwater for “several metabolites of MBIT.” More information is available in ECHA’s December 19, 2016, press release, “[BPC] adopts 17 opinions,” and in the related Annex.

MSC Agrees On SVHCs And Opinions On Two Substances: ECHA announced on December 19, 2016, that MSC unanimously agreed on the substance of very high concern (SVHC) identification of:

  • 4,4’-Isopropylidenediphenol (BPA), proposed by France, due to its toxic for reproduction properties;
  • Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts, proposed by Sweden, due to their toxic for reproduction and persistent, bioaccumulative, and toxic (PBT) properties;
  • 4-Heptylphenol, branched and linear (4-HPbl), proposed by Austria, due to their endocrine-disrupting properties for the environment, and
  • 4-Tert-pentylphenol (PTAP), proposed by Germany, due to its endocrine-disrupting properties for the environment.

ECHA included these substances in the Candidate List on January 12, 2017. For two other substances, MSC acknowledged that there is scientific evidence that 4-tert-butylphenol (PTBP), also proposed by Germany, is an endocrine disruptor, and that benzene-1,2,4-tricarboxylic acid 1,2-anhydride(trimellitic anhydride, TMA), proposed by the Netherlands, is a respiratory sensitizer. For both, the majority of the members concluded, based on the overall assessment of all factors that the information provided is sufficient to constitute an equivalent level of concern to carcinogenic, mutagenic, or toxic to reproduction (CMR) category 1A or 1B, PBT, and very persistent and very bioaccumulative (vPvB) substances. ECHA notes that a few members had different views, however. ECHA will submit the MSC opinions and the minority positions on these two substances to the EC. The EC will have three months to prepare draft proposals on their identification as SVHCs and take a final decision in its committee procedure.

Environment Council Meeting Addresses Important Issues: The Environment Council’s meeting on December 19, 2016, in Brussels, addressed a number of important issues, including chemicals, revision of the EU Emissions Trading System, sustainability, Ecolabels, and the Circular Economy. At the meeting, officials highlighted the need to “keep a high level of protection of human health and the environment in the context of the REACH review and the fitness check of the rest of the legislation on chemicals.” Some ministers also referred to the need to “raise the ambition” in the ongoing development of criteria for identification of endocrine disrupting chemicals (EDC). The Environment Council adopted conclusions on the “Protection of human health and the environment through the sound management of chemicals.”

The Environment Council “[called upon the EC], in its [Regulatory Fitness and Performance Program (REFIT)] evaluation of REACH, to pay particular attention to the following aspects”:

  • Compliance, quality, sufficiency, and usability of REACH registration information;
  • Effectiveness and efficiency of REACH risk management measures;
  • Procedures to remove dossier non-compliances or data gaps; and
  • The stability of financial basis for relevant ECHA activities post-2018.

The Environment Council indicated that the EC’s evaluation of chemicals legislation should ensure safety of manufactured nanomaterials, minimize exposure to EDCs, consider combination effects of chemicals, encourage innovation and substitution, and ensure the “public’s right to information to enable consumers to make informed choices.”

The Environment Council noted that given the decline in the number of SVHC dossiers, achievement of the objective to list all relevant SVHCs in the REACH Candidate List by 2020 is at risk. The Council invited “the [EC] and [MSs] to take appropriate measures to safeguard the timely [realization] of this objective.”

ECHA And EFSA Outline Guidance Plans For EDCs: On December 20, 2016, ECHA issued a press release entitled “Endocrine disruptors: EFSA and ECHA outline guidance plans.” The “Outline of Draft Guidance Document for the Implementation of the Hazard-based Criteria to Identify Endocrine Disruptors,” issued by ECHA and EFSA, provides an overview of the guidance being developed for identification of substances with endocrine disrupting properties in pesticides and biocides. The outline includes a projected table of contents and a plan of the drafting process, “including timelines, responsibilities, consultations with relevant parties and an explanation of how the document will be endorsed.”

The guidance will enable applicants and regulatory authorities to identify EDCs proposed as pesticides and biocides using hazard-based scientific criteria being prepared by EU MSs and the EC. The final guidance will be drafted by a joint team of scientific staff from ECHA and EFSA, supported by the EC’s Joint Research Center. Additional support will be provided in the drafting process by a “specially constituted consultation group, which will include members of ECHA’s Endocrine Disruptors Expert Group, and pesticide experts from EU [MSs] and other stakeholder groups.” The drafting group may also consult other scientific bodies (e.g., EFSA’s Scientific Committee).

A draft version of the EDC guidance is expected in the first half of 2017 and public consultation is scheduled for Summer 2017. More information is available in the “Minutes of the kick-off meeting on development of Guidance for Endocrine Disruption hazard identification” and the “Request to EFSA and ECHA for scientific assistance in order to develop a common Guidance Document for the implementation of the hazard based criteria to identify endocrine disruptors.”

Plastics Europe Issues Statement On Identification Of BPA As An SVHC: On December 20, 2016, Plastics Europe’s Polycarbonate/BPA Group issued a statement on identification of BPA as an SVHC. Plastics Europe stated while the identification of BPA as an SVHC and its inclusion in the Candidate List trigger immediate communication and documentation obligations for companies under certain conditions, the “overwhelming amount of all BPA produced is converted into polymers and only technically unavoidable trace levels of unreacted BPA may remain in the polymer matrix, usually far below the levels that would trigger SVHC-related communication or documentation obligations.”

Plastics Europe stated that BPA is used predominantly as an intermediate to manufacture polycarbonate and epoxy resin, which are “mainly polymeric materials.” Plastics Europe stated “[t]he uses of BPA to manufacture polymers would be exempt from potential later [authorization] under REACH” and no direct impact of a potential authorization would therefore be expected for polymeric uses of BPA.

Plastics Europe refers to EFSA’s conclusion that current consumer exposure to BPA poses no health risk to any age group and states “(i)n the area of food contact applications, the use of BPA is in compliance with [Regulation (EC) No 1935/2004] and permitted by [Regulation (EU) No 10/2011].” Plastics Europe stated “[t]herefore, neither the identification of BPA as an SVHC nor a potential subsequent [authorization] under REACH at a later stage would affect its approved use in plastics for food contact applications such as polycarbonate.”

EC Notifies WTO Of Draft Amendment To REACH Annex XVII Regarding CMR Substances: On December 22, 2016, the EC notified the World Trade Organization (WTO) of a draft regulation that would amend REACH Annex XVII to add the following substances:

  • Tetrahydro-2-furyl-methanol;
  • Gallium arsenide;
  • Tributyltin compounds;
  • 1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear;
  • 1,2-Dichloropropane;
  • BPA;
  • Phenol, dodecyl-, branched;
  • Phenol, 2-dodecyl-, branched;
  • Phenol, 3-dodecyl-, branched;
  • Phenol, 4-dodecyl-, branched;
  • Phenol, (tetrapropenyl) derivatives;
  • Chlorophacinone (ISO);
  • Warfarin (ISO);
  • Coumatetralyl (ISO);
  • Difenacoum (ISO);
  • Brodifacoum (ISO);
  • Flocoumafen (ISO);
  • Disodium octaborate anhydrous;
  • E-glass microfibers of representative composition;
  • Lead powder and lead massive;
  • Bromadiolone (ISO);
  • Difethialone;
  • Perfluorononan-1-oic acid, and its sodium and ammonium salts;
  • Dicyclohexyl phthalate;
  • 3,7-Dimethylocta-2,6-dienenitrile; and
  • Triflumizole (ISO).

Adding the substances to Annex XVII would restrict 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. Packaging would be required to be marked with the label “restricted to professional users.” The EC states that this is consequent on the recent classification of these substances as CMR category 1A or 1B.

EC Notifies WTO Of Proposed Changes To Cosmetics Regulation: On January 5, 2017, the EC notified the WTO of a draft Regulation and Annex that amend Annex II of Regulation (EC) No 1223/2009 on Cosmetic Products to “ban three fragrance allergens.” The draft Regulation indicates that the Scientific Committee on Consumer Safety (SCCS) concluded in its opinion of June 26-27, 2012, that the following substances are unsafe for use in consumer products:

  • 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC);
  • 2,6-Dihydroxy-4-methylbenzaldehyde (atranol); and
  • 3-Chloro-2,6-Dyhydroxy-4-methyl-benzaldehyde (chloroatranol).

The draft Regulation states “[c]onsequently, there is a potential risk to human health and those substances should therefore be prohibited in cosmetic products … It is appropriate to provide for reasonable periods of time in order for the industry to adapt to the new prohibitions and for this reason no longer place on the market and withdraw from the market products concerned which contain one or more of the prohibited substances.”

The draft Regulation prohibits placing on the market of products containing one or more of the relevant substances “[two] years after the date of entry into force” of the Regulation. Four years after the date of entry into force of the draft Regulation, products containing the relevant substances are required to be “withdrawn from the Union market.” The final date for comments on the draft Regulation is 60 days from the notification to WTO.

The proposed date of adoption for the draft Regulation is mid-March 2017. The draft Regulation will enter into force on the twentieth day following its publication in the Official Journal of the EU.

EC’s Report Addresses EDC Authorization Under REACH: On January 9, 2017, the EC’s report on EDCs to the EP, the Council of the EU, and the European Economic and Social Committee was published. The report was a result of the REACH Article 138(7) obligation on the EC to “carry out a review to assess whether or not, taking into account latest developments in scientific knowledge, to extend the scope of Article 60(3) to substances identified under Article 57(f) as having endocrine disrupting properties.” In particular, the EC was required to consider whether EDCs should only be authorized under REACH via the “Socio-Economic Route.” Due to the scope of REACH Article 57(f), the EC’s report focuses on EDCs that have “probable serious effects to human health or the environment which give rise to an equivalent level of concern to CMRs [under Categories 1A and 1B] and PBT/vPvBs.”

For the purpose of the report, the EC defines a substance having endocrine disrupting properties “[as] an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations.” Use of this definition is consistent with the EC’s June 15, 2016, publication of draft scientific criteria for the determination of endocrine disrupting properties pursuant to the legislation on biocidal products and plant protection products. On a related note, EU MSs have not yet reached agreement on the revised criteria proposed by the EC for identification of EDCs.

The EC’s report considers thresholds for EDCs and includes several sections that address science and policy considerations in relation to managing EDCs as SVHCs under REACH. The report states that it is already established that for substances for which it is not possible to determine a threshold, the “Adequate Control Route” for REACH SVHC authorization is not available. The EC concludes in the report that it is not appropriate to extend “a-priori” the scope of REACH Article 60(3) to substances under Article 57(f).

Consequently, REACH Article 60(3) will continue to apply to EDCs for which it is not possible to determine a threshold. The EC states “(i)t remains the responsibility of applicants for [authorization] to demonstrate that a threshold exists and to determine that threshold in accordance with Annex I to REACH … [Under] REACH as it stands today only the ‘Socio-Economic Route’ can be used when a threshold cannot be determined, and considering the conclusion of the REACH Review that regulatory stability is desirable, the [EC] will not propose a change to the legislation.”

REF-5 Will Focus On Safety Of Workers: The REACH-EN-FORCE 5 (REF-5) project was adopted by ECHA’s Forum for Exchange of Information on Enforcement at the end of 2015. Inspections under REF-5 will take place in January 2017, and the activity will continue throughout the year. A report on the results of inspections will be available in the fourth quarter of 2018.

REF-5 is the first joint EU enforcement project that “aims to improve communication, through [Safety Data Sheets (SDS)], throughout the supply chain.” The safety of workers will be inspected by 28 EU and European Economic Area MSs. The key element of REF-5 is to investigate the quality of SDSs that contain guidelines on the safe use of hazardous substances. Inspectors will check if extended SDSs match information established by Chemical Safety Reports (CSR) that manufacturers prepare. Additionally, inspectors will review exposure scenarios attached to SDSs and “check whether workers actually respect safety information at their workplaces.” Inspectors from national enforcement authorities will collaborate with labor inspectors to assess if the recommended operational conditions and risk management measures are fulfilled.

ECHA stated that “[o]ne of the objectives of this enforcement project is to ensure that workers handling hazardous chemicals, especially those dealing with [SVHCs], receive sufficient and correct safety information. The project will also map how effectively [extended SDSs] are passed on and communicated all the way through the supply chain.”

More information is available in ECHA’s January 10, 2017, press release entitled “Chemical safety for workers targeted by next EU enforcement project.”

Industry Criticizes ENVI’s Vote On CETA: On January 12, 2017, the Center for International Environmental Law (CIEL) issued a press release entitled “Vote on EU-Canada deal disappoints health groups.” CIEL stated “[35] organizations committed to maintaining effective chemical safety regulation in Europe are dismayed by today’s vote on the controversial EU-Canada trade and investment deal. The groups are health, environmental and other civil society [organizations].”

CIEL stated that the EP’s Committee on the Environment, Public Health and Food Safety (ENVI) chose to support the Comprehensive Economic and Trade Agreement (CETA) despite the views outlined in an opinion paper. CIEL indicated that the 35 organizations that previously wrote to ENVI believe CETA puts the decision-making powers of the EU and its MSs in a straitjacket by prioritizing trade interests over public health and the environment. The organizations are particularly concerned that CETA undermines chemical safety regulation, particularly in relation to EDCs.

Regarding EDCs and other chemicals, the organizations stated in their letter to ENVI “CETA chapters four (‘Technical Barriers to Trade’), five (‘Sanitary and Phytosanitary Measures’) and [21] (‘Regulatory Cooperation’) would extend the influence of Canada on the EU internal regulatory process and would directly affect areas such as EDCs, REACH and its implementation, pesticides and biocides rules. CETA would empower Canada and businesses based in Canada (such as Monsanto) to challenge such legislation in the EU and its [MSs]. Any provisional application of CETA would thus pose an immediate risk to health and environmental protection in Europe.”

The final vote on CETA in the EP is expected to take place in February 2017.

ECHA Adds Four New SVHCs To Candidate List: On January 12, 2017, ECHA announced that it added four new SVHCs to the Candidate List based on proposals by France, Sweden, Germany, and Austria, following the SVHC identification process with involvement of MSC. The SVHCs and their SVHC properties include:

Substance nameReason for inclusionExamples of use(s)
4,4’-isopropylidenediphenol (bisphenol A; BPA)Toxic for reproduction (Article 57c)Manufacture of polycarbonate, epoxy resins and chemicals; hardener in epoxy resins
Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium saltsToxic for reproduction (Article 57c)PBT (Article 57d)Lubricant, wetting agent, plasticizer, and corrosion inhibitor
p-(1,1-dimethylpropyl)phenolEquivalent level of concern having probable serious effects to environment (Article 57f)Manufacture of chemicals and plastic products
4-heptylphenol, branched and linear [substances with a linear and/or branched alkyl chain with a carbon number of 7 covalently bound predominantly in position 4 to phenol, covering also unknown or variable composition, complex reaction products, or biological materials (UVCB)- and well-defined substances which include any of the individual isomers or a combination thereof]Equivalent level of concern having probable serious effects to environment (Article 57f)Manufacture of polymers; formulation into lubricants

Committees Reviewing Draft Appendix On Recommendations For Nanomaterials Applicable To The Guidance On Registration: On January 13, 2017, ECHA sent the draft appendix on recommendations for nanomaterials applicable to the guidance on registration to the Forum, MSC, and RAC for consultation. The draft guidance outlines the minimum elements potential registrants need to consider when registering substances that fulfil the EC’s Recommendation for the definition of nanomaterial. The aim of the draft guidance is to define the term “nanoform,” the minimum criteria for distinguishing between different nanoforms, and the minimum set of elements that should be reported on the characterization of nanoforms. The draft guidance defines nanoform as a substance that meets the requirements of the EC’s Recommendation for the definition of nanomaterial and has a shape and a surface chemistry. The three minimum elements to characterize nanoforms are: (1) size; (2) shape; and (3) surface chemistry. The draft guidance notes that these are the minimum elements necessary to characterize registered nanoforms in a registration dossier, and additional elements and/or additional refinement of these elements may need to be reported. The draft guidance includes a hypothetical example of the minimum elements that would be needed to report a nanoform.


South Korea Proposes To Revise K-REACH: On December 28, 2016, the Ministry of the Environment (MOE) began a public consultation on proposed revisions to the Act for the Registration and Evaluation of Chemicals (K-REACH), including:

  • Abolishing the annual reporting system ;
  • Adopting a pre-registration system;
  • Deleting the system for designating Priority Existing Chemicals (PEC) in three batches for registration. Instead, a phase-in registration mechanism for approximately 7,000 existing chemical substances manufactured or imported in volumes greater than or equal to one ton per year would be applied. Phase-in deadlines would be set based on tonnage band (one to ten tons per year; ten to 100 tons per year; 100 to 1,000 tons per year; and greater than 1,000 tons per year), similar to EU REACH;
  • Improving management of substances subject to authorization;
  • Providing more hazard information through the supply chain and to consumers;
  • Expanding the application scope for notification of products containing hazardous substances. In addition to hazardous chemical substances defined under K-REACH, CMR and PBT substances would also be subject to product notification; and
  • Imposing penalties for the manufacture, importation, or sale of chemicals that cause any harm to human health or the environment and that should have been registered.

If the proposed changes are adopted, they would likely take effect one year after being issued in final. The June 30, 2017, deadline for annual reporting would still be a requirement. According to MOE, the June 30, 2018, deadline to register 510 PECs will remain in affect. Comments are due February 6, 2017.

South Korea Notifies WTO Of Draft Biocides Legislation: On January 12, 2017, South Korea notified WTO of a draft proposal for an Act on Safety Management of Consumer Chemical Products and Biocides. The Act addresses the safety management of consumer chemical products, approval of biocidal substances, authorization of biocidal products, safety management of treated articles, data protection and sharing, and distribution management of consumer chemical products and biocides. The proposed date of adoption is January 1, 2018, and the proposed date of entry into force is January 1, 2019. MOE has begun a public consultation. Comments are due February 6, 2017.


Sweden Taking EC To ECJ For Lead Chromates Authorization: On November 28, 2016, the Swedish government announced that it has referred the EC’s decision authorizing the “continued use of lead chromates in the EU” to the ECJ for a preliminary ruling. The Swedish gvernment stated “[t]he decision is bad for people’s health and distorts competition for responsible businesses that have stopped using these hazardous substances.”

The actions of the Swedish government are a result of the authorization granted by the EC in September 2016 to Dominion Color Corporation for uses of two lead chromate pigments (i.e., Red 104 and Yellow 34) for use in industrial coatings, plastics, and road markings. According to mandatory classifications, both pigments are carcinogenic, reprotoxic, and toxic to aquatic life.

The Swedish Government stated “(b)ecause lead pigments are often cheaper than the alternatives, businesses that choose to sell these paints will gain a competitive advantage over businesses that have chosen to remove hazardous lead chromates. The [EC’s] decision thus sends a signal that it is not worthwhile for businesses to phase out particularly hazardous substances. By referring the decision for a preliminary ruling, the Government is also standing up for healthy competition in the European Single Market … The chemicals regulations in the EU clearly state that [authorizations] for [these kinds] of hazardous substances may only be granted where there are no available alternatives. Such alternatives are available in the case of lead chromates, a fact demonstrated by Swedish businesses and others that have phased out their use.”

The International Chemical Secretariat (ChemSec) welcomed the measure taken by Sweden in its press release entitled “Sweden is suing the Commission over lead chromates [authorization].” ChemSec identified potential risks associated with lead chromate use (e.g., harms the nervous system, can cause lung tumors, children particularly vulnerable) and stated “(i)n Sweden, [these toxic paint components] have not been used for 30 years. Many paint companies publicly state that alternatives do exist and that they have been using them for years. The decision to allow one company to continue the use disfavors these progressive companies who already invested in alternative techniques.”

More information is available, in Swedish, in Kemikalieinspektionen’s (KEMI) press release, “Sverige stämmer EU-kommissionen om blykromater.”


Taiwan Creates Bureau For Toxics And Chemical Substances: On December 9, 2016, the legislature approved a bill creating a Bureau for Toxics and Chemical Substances. The Bureau’s duties will include forming, implementing, and enforcing policies on toxic and chemical substance regulation, chemical accidents and emergency response, and environmental agent regulation. The Bureau will also promote the integration and use of chemical information; technological advances related to toxic chemical regulation; and international cooperation on chemical substance regulation. The Bureau will coordinate the almost dozen government agencies involved in enforcing a number of laws regulating toxic and chemical substances.


DEFRA, Scotland, Wales, And Northern Ireland Start Consultation On Microbeads Ban: On December 20, 2016, the UK’s Department for Environment, Food, and Rural Affairs (DEFRA), the Scottish Government, the Welsh Government, and the Department of Agriculture, Environment, and Rural Affairs in Northern Ireland started a consultation on the UK’s proposed ban on the use of plastic microbeads in cosmetics and personal care products.

The purpose of the consultation is to obtain opinions on the UK’s proposals to ban the manufacture and sale of cosmetics and personal care products containing microbeads “which may harm the marine environment.” The consultation also seeks to gather evidence on the extent of the environmental impacts of further sources of potential marine plastic pollution, to inform future UK actions to protect the marine environment. DEFRA states “[g]overnment action will create a level playing field for industry, tackle inconsistency, provide consumer confidence and stop new products containing tiny pieces of plastic ending up in the marine environment. This will contribute to the UK government and devolved administrations’ vision of ‘clean, healthy, safe, productive and biologically diverse oceans and seas’ as set out in the UK Marine Policy Statement.”

DEFRA indicated that the consultation should be of particular interest to businesses involved in manufacture and sale of cosmetics and personal care products containing microbeads, their trade associations, and NGOs concerned about the status of the marine environment. Consultees can respond using an online survey or by submitting written responses by February 28, 2017.

Greenpeace welcomed the consultation, but criticized the fact that “the government’s proposed ban is limited to just personal care and cosmetic products, despite the consultation document admitting that microbeads are found in ‘washing powders, household cleaners’ and other items not included in their draft ban.” More information is available in the “Proposals to ban the use of plastic microbeads in cosmetics and personal care products in the UK and call for evidence on other sources of microplastics entering the marine environment.”

Environmental Audit Committee Completes Consultation On Brexit And REACH: On December 21, 2016, the UK Parliament’s Environmental Audit Committee announced the launch of “a second inquiry into the future of environmental law and policy following the result of the EU Referendum.” The focus of this inquiry is REACH, in the context of Brexit.

The Environmental Audit Committee acknowledged the importance of REACH and stated that “relatively little of its regulation has been transposed into UK law.” The Committee stated that while Prime Minister Theresa May has indicated that leaving the EU will involve converting the “body of EU law into British law (via a ‘Great Repeal Bill’),” up to a third of EU environmental law cannot be simply “copy pasted” into UK law and will require “additional work to ensure that the UK maintains the current level of environmental protection.” The Committee stated that REACH was cited in the evidence to its Future of the Natural Environment inquiry as one of these challenging areas.

The Environmental Audit Committee invited submissions on the following questions, among others:

  • What particular challenges will the UK Government face when it seeks to transpose REACH into UK law through the Great Repeal Bill?
  • How far will the UK’s ability to effectively transpose REACH depend on negotiations with other MSs and the nature of the UK’s future relationship with the EU?
  • How should administrative and enforcement responsibilities, which are currently being carried out by the EC or EU Agencies (e.g., ECHA), be transferred to domestic bodies?
  • What scope is there for the UK to pursue a divergent approach to chemicals regulation from the EU once the process of leaving has been completed?
  • What principles should a UK chemicals regulation regime follow?

The deadline for submissions of up to 3,000 words was January 20, 2017.

Supreme Court Decides An Act Of Parliament Is Needed To Trigger Article 50: On January 24, 2017, the Supreme Court issued its judgment in R (on the application of Miller and another) (Respondents) v Secretary of State for Exiting the EU (Appellant) and Associated References. The four-day hearing in the Supreme Court was a result of the Government’s appeal against the High Court of Justice Queen’s Bench Division Divisional Court’s judgment in R (Miller) v Secretary of State for Exiting the EU. The Divisional Court decided that the Government did not have the power under the Crown’s prerogative to give notice pursuant to Article 50 of the Lisbon Treaty for the UK to withdraw from the EU, and that Parliament must vote on whether Article 50 can be triggered. Additional detail on the Divisional Court’s judgment and other Brexit-related issues is available in Acta’s memorandum of December 1, 2016, entitled “Brexit — An Overview of Transformative Developments and Their Potential Impact on European Chemical Laws.”

The Government’s “Grounds of Appeal” to bring the Article 50 question before the Supreme Court were:

  • The Divisional Court erred in ruling that the Crown has no legal power to commence a withdrawal from EU Treaties by giving notice under Article 50. Specifically, the Divisional Court erred in:
    • Holding that the necessary implication of the European Communities Act 1972 (ECA 1972) was that the Crown had no such prerogative power; and
    • Taking the “alternative approach” of asking whether ECA 1972 conferred “positive authority” to give such notice, and concluding that it did not.
  • The Divisional Court should have ruled, in summary, that:
    • The Crown retains the power to give effect to the result of the referendum, provided for specifically by the EU Referendum Act 2015, by giving “the notice” under Article 50;
    • “[That] is the constitutionally normal and unsurprising position, given the UK’s longstanding dualist approach to [International Law]”;
    • Neither ECA 1972 nor the other parts of the relevant legislative scheme (e.g., EU Amendment Act 2008, EU Act 2011, EU Referendum Act 2015) “indicate that the power [to trigger Article 50] has been removed by Parliament, expressly or by necessary implication”; and
    • In any event, the continued existence of the power to [“take that first step” (i.e., trigger Article 50)] is clearly established and authorized by Parliament.

Arguments against the Government in the Supreme Court case included: (1) if the Government gave notice under Article 50(2), statutory rights created under ECA 1972 by Parliament would be destroyed or frustrated; (2) the Government may not lawfully use prerogative powers to defeat the aforementioned statutory rights; (3) where Parliament has created statutory rights, and in particular statutory rights of constitutional significance, at Common Law the Government has no prerogative power to take action which will defeat those rights (clear statutory authority is required); and (4) the Government failed to recognize a series of fundamental principles (e.g., Parliamentary Sovereignty) of domestic law that strongly support the contention that it cannot have been the intention of Parliament when enacting ECA 1972 and the European Parliamentary Elections Act 2002 to authorize the Government by the use of “the prerogative” to defeat or frustrate the rights Parliament has created.

The principal question before the Supreme Court was whether notice under Article 50 can lawfully be given by Government ministers without prior authorization by an Act of Parliament. References from Northern Ireland, and interventions by the Lord Advocate for the Scottish Government and the Counsel General for Wales for the Welsh Government, raised additional issues regarding whether the terms on which powers have been statutorily devolved require consultation with, or the agreement of, the devolved legislatures before Article 50 notice is served, or otherwise operate to restrict the Government’s power to withdraw from the EU.

The Supreme Court decided, “by a majority of [eight] to [three],” that an Act of Parliament is required to authorize ministers to give Article 50 notice. The Supreme Court considered that the terms of ECA 1972, which gave effect to the UK’s membership of the EU, are inconsistent with the exercise by ministers of any power to withdraw from EU Treaties without authorization by a prior Act of Parliament. The Supreme Court opined that Section 2 of ECA 1972 authorizes a “dynamic process” by which EU law becomes a source of UK law and takes precedence over domestic sources of UK law, including statutes. Therefore, the Supreme Court provided that, until ECA 1972 remains in force, its effect is to constitute EU law as an independent and overriding source of domestic law. In this regard, the Supreme Court’s press summary states “(i)t operates as a partial transfer of law-making powers, an assignment of legislative competences, by Parliament to EU institutions, unless and until Parliament decides otherwise.”

The Supreme Court opined that there is a vital difference between variations of UK law resulting from changes in EU law, and variations in UK law resulting from withdrawal from EU Treaties. The Court provided that because Article 50 notice would invariably result in withdrawal from EU Treaties and cut off the source of EU law, Parliamentary legislation is required under the UK Constitution to make such a change. Additionally, Supreme Court judges expressed that as withdrawal from the EU would remove some existing domestic rights of UK residents, it is impermissible for the Government to withdraw from EU Treaties without prior Parliamentary authority. The Supreme Court indicated that ECA 1972 contains “[no clear words]” that ministers can trigger Article 50 as part of their prerogative powers, and in fact, “[supports] the contrary view.” The Court indicated that it “must take legislation as is,” and that it could not accept that in “Part I of [ECA 1972], Parliament ‘squarely confront[ed]’ the notion that it was clothing ministers with the far-reaching and anomalous right to use a treaty-making power to remove an important source of domestic law and important domestic rights.”

Regarding the legal standing of the EU referendum on June 23, 2016, the Supreme Court indicated that the statute authorizing the referendum simply provided for the referendum to be held, without specifying the consequences. As a result, the Court concluded, that the change in UK law required to implement the referendum’s outcome must be made “in the only way permitted by the UK [Constitution], namely by legislation.”

On the devolution issues, the Supreme Court decided that the UK’s relations with the EU and other foreign affairs matters are “reserved to the UK Government and [Parliament], not to the devolved institutions.” Consequently, the UK’s withdrawal from the EU would alter the competence of the devolved institutions, and remove the responsibilities to comply with EU law. In light of the Court’s decision that primary legislation is required for the UK to withdraw from the EU, it was considered unnecessary for the Court to decide if the Northern Ireland Act 1998 (NIA 1998) imposes a “discrete requirement for such legislation.”

Furthermore, the Supreme Court emphasized the limitations of NIA 1998 Sections 1 and 75 in relation to withdrawal from the EU. The Supreme Court indicated that “the policing of [the Sewel Convention’s] scope and the manner of its operation does not lie within the constitutional remit of the judiciary, which is to protect the rule of law.” Consequently, the Supreme Court interpreted that the devolved legislatures “do not have a veto on the UK’s decision to withdraw from the EU.”

More information is available in the full judgment of the Supreme Court.