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January 1, 2019

Global Regulatory Update for January 2019

The ACTA Group

Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) published on January 8, 2019, our “Forecast for U.S. Federal and International Chemical Regulatory Policy 2019.” In this richly detailed document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and provide our best informed judgment as to the shape of key developments we are likely to see in 2019. This edition contains new features — a detailed table of contents, more detail (the document is 70 pages), a glossary, the schedule of our complimentary webinars in 2019, links to key writings, and a summary of key presentations.


Institutional Coordination On Chemicals and Waste Management Under Development: The Argentinian Dirección de Sustancias y Productos Químicos (Directorate of Substances and Chemical Products; Directorate), a new Directorate created in 2018 with funding from the United Nations (UN) Environment’s Special Programme on Institutional Strengthening for Chemicals and Waste Management, has begun to settle more fully into its mandate of ensuring adequate personnel and infrastructure to implement various international conventions to which the country is a party.

The Directorate falls administratively under the Dirección de Productos Químicos y Residuos, (Directorate of Chemicals and Waste), a department that has been tasked with promoting cooperation and coordination among the relevant stakeholders, developing training plans, evaluating the country’s degree of compliance with the conventions, and designing strategies to effectively manage emerging regulatory actions and challenges. The establishment of the Directorate consolidates Argentina’s capacity to manage chemicals and wastes in a manner that is both efficient and cost-effective. The Directorate has identified the following challenges relating to chemical substance management in the country: limited access to information related to chemicals production, a lack of motivation for various types of stakeholders to participate in national and international goals, and a relatively “weak image” of chemicals in both the public agenda and the general public interest. The Directorate plans to release its work agenda for 2019 shortly.


Legislation To Implement NICNAS Reforms Awaiting Debate In Senate, Reforms Postponed To 2020: According to the December 18, 2018, National Industrial Chemicals Notification and Assessment Scheme (NICNAS) Stakeholder Update, the legislation is awaiting debate in the Senate in 2019. On January 14, 2019, NICNAS announced that the government has considered options to address issues associated with the revised timeline. To assist regulated entities to prepare adequately for implementation of the Australian Industrial Chemicals Introduction Scheme (AICIS), it has decided to postpone commencement of the scheme to July 1, 2020. Government amendments to change the commencement date will be moved at the time of debate in the Senate.


Brazil Drafts Cosmetics Labeling Resolution: On November 23, 2018, the Agencia Nacional de Vigilancia Sanitaria (National Sanitary Surveillance Agency (ANVISA)) issued Resolution RDC 250/2018 (RDC 250), which set forth the requirements for labeling related to hygiene products, cosmetics, and perfumes. The main impetus for RDC 250 was to enhance the nimbleness of the cosmetics sector in Brazil, and to reduce the cost of labeling processes within organizations. Prior to the passage of RDC 250, organizations were required to submit every label change for cosmetic products (including those that did not impact the efficacy of the product, such as promotional language or colors) to ANVISA for review. Additionally, ANVISA did not allow for multiple (different) labels for the same product to coexist. RDC 250 allows manufacturers of cosmetics and personal care products to more effectively manage different labeling variations for the same base product. Moving forward, only changes related to safety and addressing the benefits of products will require the submission of labeling to ANVISA.

Brazil Continues To Move Forward on Industrial Chemicals Law: The Brazilian Ministerio de Medio Ambiente (Ministry of Environment) has published a draft bill to establish a general regulatory scheme for chemical substances. The bill, “Sobre el Inventario, Evaluación y Control de Sustancias Químicas (On the Inventory, Evaluation, and Control of Chemical Substances”) is the revision of the initial draft from June 2016, the Regulación de Productos Químicos Industrials (Industrial Chemicals Regulation), and includes many of the comments and related items presented by industry, trade associations, and the public.


Canada Publishes Updates To Two-Year Rolling Work Plans (2018-2020): On December 14, 2018, Canada published updates to the two-year rolling work plans (2018-2020):

Canada Publishes Results Of 2017-2018 CMP Prioritization Exercise: On January 14, 2018, Canada announced the availability of the results of the 2017-2018 CMP prioritization exercise results. The Identification of Risk Assessment Priorities: Results of the 2017-2018 Review and its supporting document describe how the approach was applied to identify chemicals and polymers, beyond those identified through the Domestic Substances List (DSL) categorization, as risk assessment priorities under CEPA. Canada primarily focused on identifying new information that would constitute indicators of hazard and/or exposure for the following types of substances:

  • Substances on the DSL that have not been assessed within the last five years, and are not scheduled to be assessed under the CMP;
  • Previously assessed substances that were not found to meet the criteria under CEPA Section 64, depending on the time elapsed since data/information on the substance was last reviewed;
  • Substances that were nominated by CMP Program staff as being of potential concern based on knowledge acquired through research and/or expertise gained from previous assessments; and
  • Substances identified as potentially requiring review pursuant to CEPA Section 75.

After searching the pertinent sources of information, the process identified approximately 8,400 substances that fit the scope of the review and had at least one new piece of information representing potential indicators requiring further consideration. The analysis identified substances that are:

  • Unlikely to require further work based on information available (approximately 7,100 chemical substances);
  • New candidates for risk assessment (one chemical substance, 1-H-benzotriazole);
  • Likely to require further data gathering (58 chemical substances);
  • Likely to require further scoping/problem formulation (1,094 chemical substances); or
  • Subjects of ongoing international activities (77 chemical substances).

Canada Begins Consultation On Informed Substitution: Canada announced on January 16, 2019, a public consultation seeking comments for advancing informed substitution in Canada. Health Canada and Environment and Climate Change Canada are exploring ways to support informed substitution and drive Canadian innovation and the adoption of safer chemistry. Canada states that informed substitution “is the considered transition from a chemical of concern to safer chemicals or non-chemical alternatives, and is an internationally recognized strategy for reducing health and environmental risks posed by chemicals.” Canada commissioned the Lowell Center for Sustainable Production to conduct a study to identify potential ways for Canada to advance informed substitution in a future iteration of the CMP after 2020. The purpose of the consultation is to solicit feedback on the proposed elements and activities outlined in the study. The key questions for discussion include:

  • Who are the partners that have a role to play in considering informed substitution, and what role should each of them play;
  • Are there considerations or is there information missing from the study; and
  • Are there potential costs, benefits, or impacts of informed substitution on the health of Canadians, the environment, companies, or others.

Canada will consider this feedback when planning the next phase of chemicals management in Canada. Comments are due March 18, 2019.

Canada Announces Healthy Home Social Marketing Campaign: On January 18, 2019, Canada announced the launch of the Healthy Home social marketing campaign, a “key CMP public outreach initiative led by Health Canada.” The objective of Healthy Home is to raise awareness among Canadians about the health risks from chemicals and pollutants that might be in and around their home and to encourage them to take measures to make their home and families safer and healthier. Topics include:


Chamber of Deputies Proposes Update To Fertilizer Legislation: The lower house of the Chilean Congress, the Cámara de Diputados (Chamber of Deputies), has proposed Bulletin 12233 (Bulletin), which amends the requirements relating to the importation of fertilizers. This Bulletin updates Resolution 1035/10 of the Servicio Agrícola y Ganadero (Agriculture and Livestock Service (SAG)), enacted February 18, 2011. The Bulletin contains two key parts: in addition to setting out a series of specific definitions such as “biofertilizers,” “composition,” “label,” “amendment,” “manufacturer,” “fertilizer,” “quality parameters,” “traceability,” and “user,” among others, the Bulletin obligates those who produce, manufacture, formulate, market, pack, import, or export fertilizers that are used for non-agricultural purposes to register them in the Registro Único Nacional (National Single Registry). Such registration must be completed within 30 days.

The Bulletin also introduces quality parameters that must be followed by the aforementioned categories of entities, as well as the composition (to hundredths of a percent) of nutrients and “accompanying elements” in the product formulation. SAG is additionally empowered to set out the processes and procedures for sampling and analysis of fertilizers subject to its jurisdiction.


China Publishes Chemical Environmental Risk Assessment And Control Regulation To Update MEP Order No. 7 For Public Comment: After over a year of review and revision, on January 8, 2019, the Chinese Ministry of Ecology and Environment (MEE) published the “Chemical Environmental Risk Assessment and Control Regulation (Draft)” (Regulation) for public comment. The draft Regulation would update the “Environmental Management of New Chemical Substances” (MEP Order No. 7). The draft Regulation includes risk assessment and management of new and existing chemical substances; the key provisions include:

  • Scope: The scope of the Regulation is expanded from new chemical substances to all chemical substances, including both existing and new chemical substances;
  • Inventory and Lists: Risk assessment and control of chemical substances are managed under the lists based on priority and risk;
  • Registration of New Chemical Substances; and
  • Risk Assessment and Reporting of Chemical Substances.

The deadline to submit comments to MEE regarding the Regulation is February 20, 2019. Comments should be submitted to MEE via e-mail ( More information is available in Acta’s January 16, 2019, memorandum, “China Publishes Chemical Environmental Risk Assessment and Control Regulation to Update MEP Order No. 7 for Public Comment.”


EP Passes Bill Updating Rules Protecting Workers From Exposure To Carcinogenic And Mutagenic Substances: On December 11, 2018, the European Parliament (EP) passed legislation updating rules to protect workers from carcinogenic and mutagenic substances, including diesel fumes. The legislation sets exposure limit values and skin notations for eight additional carcinogens:

  • Diesel engine exhaust emissions;
  • Epichlorohydrine;
  • Ethylene dibromide;
  • Ethylene dichloride;
  • 4,4’-Methylenedianiline;
  • Trichloroethylene;
  • Polycyclic aromatic hydrocarbons (PAH) mixtures, particularly those containing benzo[a]pyrene; and
  • Mineral oils that have been used before in internal combustion engines to lubricate and cool the moving parts within the engine.

The EP states that the amended rules “should further lower the risk for workers of getting cancer, which remains the primary cause of work-related deaths across the EU.” More information is available in the EP’s December 11, 2018, press release, “Workplace risks: Final vote on protection from carcinogens, including diesel fumes.” The European Commission (EC) posted on December 20, 2018, frequently asked questions (FAQ) regarding the legislation. The EC published the second revision of the Carcinogens and Mutagens Directive in the January 16, 2019, Official Journal of the European Union. The Directive will enter into force on the 20th day following publication. Member States will have two years to transpose the Directive.

ClientEarth Urges EC To Improve Timing And Transparency For Authorizations And Restrictions Under REACH: On December 11, 2018, ClientEarth issued a letter to the Director Generals of the Directorate-General for Internal Market, Industry, Entrepreneurship, and Small and Medium-sized Enterprises (DG GROW) and the Directorate-General for the Environment (DG Environment), Ms. Lowri Evans and Mr. Daniel Calleja Crespo. In the letter, Dr. Apolline Roger and Ms. Alice Bernard of ClientEarth state “while we agree that the [Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)] Regulation is ‘the most advanced and comprehensive chemical legislation in the world’ … [T]his does not mean much if its implementation is not up to the standard of the legal text. When it is not, both the reputation of the EU and the main objective of this legislation — the prevention of harm to human and environmental health — are undermined.”

In the letter, ClientEarth indicates that delays by the EC in authorization and restriction processes may lead to longer exposure to dangerous chemicals in conditions that are not adequately controlled. ClientEarth suggests that such delays may also lead to an unduly extended occupation of the market by chemicals that are dangerous for health and the environment, undermining the development of safer alternatives. ClientEarth states “[t]he prevention and proper management of delays therefore have to be made a priority.”

ClientEarth acknowledges progress made by the EC to remedy delays and improve transparency in the REACH regulation authorization and restriction processes since its “initial letter in [June 2018],” and indicates that respecting legal timelines must not impair the scrutiny level for each file or result in greater leniency. ClientEarth states “[t]he responsibility of the decision rests on the Commission in the end, which makes it the institution responsible for adopting [authorization] and restriction decisions that ensure the high level of environmental and health protection aimed at by REACH.” In the authorization context, ClientEarth suggests that better internal arrangements to process cases, and improvements in applications, are required to avoid delays. In this regard, ClientEarth suggests the following measures:

  • “Creating the conditions that will fully convince companies to submit to [the European Chemicals Agency (ECHA)] applications containing information that is precise, relevant and exhaustive enough to properly and efficiently assess them against the criteria set by REACH”;
  • Rejecting inadequate applications to indicate clearly to potential applicants that only complete, precise, and adequate applications should be submitted;
  • Stopping to over-rely on the information provided by the applicants, by, for example, reaching further to relevant third parties; and
  • “Maintaining the burden of proving that the conditions set by REACH are fulfilled on the applicant, in application of REACH.”

Regarding delays in authorization decisions, ClientEarth states “[a]s you explained in your letter and in our meetings, backlogs may happen when many applications are submitted at the same time, when the cases are complex or for other reasons.” ClientEarth asserts that, when backlogs occur, prioritization of applications made by companies that have missed deadlines, “which has happened in the past,” is not acceptable from a legal or policy point of view.

ClientEarth states that “REACH’s main objective is the protection of health and environment,” and therefore any prioritization should be based on “the necessity to act quickly to better protect health and environment.” As an example, ClientEarth refers to a scenario where ECHA’s Committee for Risk Assessment (RAC) considers that risk management measures proposed by an applicant are not sufficient, and thus additional measures need to be imposed to limit the exposure of people or the environment to the substance of very high concern (SVHC).

ClientEarth further states that the EC needs to “offer more transparency on the reasons why delays happen” under REACH. Additional information is available in the Annex to ClientEarth’s letter of December 11, 2018.

REACH Enforcement Project Calls For Improved Safety Information To Protect Workers: ECHA announced on December 13, 2018, the results of REACH-EN-FORCE-5 (REF-5), which focused on checking how companies communicate safety information on hazardous chemicals to their customers. The project aimed to raise awareness about extended safety data sheets (SDS) and to get a picture of how effectively the safe use information they contain is communicated to the users. During REF-5, enforcement authorities from 29 EU and European Economic Area (EEA) countries conducted 898 inspections for 1,435 substances. Inspectors focused on companies’ obligation under REACH to prepare an exposure scenario that describes the risk management measures in the chemical safety report, and to ensure that the information from this scenario is passed down the supply chain in an extended SDS. Inspectors also checked whether downstream users implement these risk management measures or prepare their own safety assessments. Inspectors gave special attention to whether workers handling hazardous chemicals received safe use information and to how this was applied in the workplace. According to ECHA, the project’s key finding was that while companies have systems in place to communicate safe use information down the supply chain, the quality of the information needs to improve significantly. More information is available in ECHA’s press release, “Enforcement project calls for improved safety information to protect workers from chemical hazards.”

Management Board Adopts ECHA Strategic Plan For 2019-2023: ECHA announced on December 14, 2018, that the Management Board adopted a new strategic plan for ECHA for 2019-2023. The strategic plan contains ECHA’s new mission and vision:

ECHA’s Mission: We, together with our partners, work for the safe use of chemicals.

ECHA’s Vision: To be the centre of knowledge on the sustainable management of chemicals, serving a wide range of EU policies and global initiatives, for the benefit of citizens and the environment.

The new strategy identifies three strategic priorities:

  • Identification and risk management of substances of concern:
    • Prioritize groups of substances;
    • Concerted regulatory action; and
    • Induce faster action by industry;
  • Safe and sustainable use of chemicals by industry:
    • Strengthen the knowledge base on substances in articles;
    • Support the substitution and sustainable use of chemicals; and
    • Improve supply chain communication; and
  • Sustainable management of chemicals through the implementation of EU legislation:
    • Consistency and integration of the EU regulatory system for chemicals safety; and
    • Foster synergies at the international level.

More information is available in ECHA’s press release, “ECHA’s future strategic plan: making the best use of information on chemicals in Europe.”

ECHA Consults On Authorization List Amendments For Phthalates: ECHA has started public consultation on a draft recommendation to amend the REACH Annex XIV Authorization List entries for the following four phthalates to include their endocrine-disrupting properties:

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

ECHA indicates that the four phthalates were identified as SVHCs due to their classification as toxic for reproduction, and added to the Candidate List in 2008 and 2010. Following ECHA’s recommendations, these substances were included in the Authorization List in 2011 and 2012. After inclusion in the Authorization List, these four substances were additionally identified as having endocrine disrupting properties with effects on human health and, in the case of DEHP, also on the environment. The Candidate List was updated accordingly in 2014 and 2017. The EC is currently considering the inclusion of endocrine-disrupting properties into the respective entries for the four substances in the Authorization List.

In accordance with REACH Article 58, ECHA is inviting interested parties to submit comments on the draft recommendation until March 12, 2019. The purpose of the consultation is to receive relevant information, in particular from those actors affected by the change in authorization requirements due to the inclusion of additional intrinsic properties of the four phthalates. Interested parties are invited to send comments on the following:

  • Transitional arrangements (comments on the proposed dates);
  • Uses that should be exempted from authorization, including reasons for that; and
  • Uses for which review periods should be included in Annex XIV, including reasons for that.

ECHA states this amendment would mean that some uses which until now have been exempted may require authorization, such as:

  • Uses of the four phthalates in mixtures in concentrations equal to or above 0.1 percent weight by weight (so far the concentration limit has been 0.3 percent weight by weight); and
  • Some uses of DEHP (e.g., in food contact materials or medical devices) that will no longer fall under the “generic exemptions from the authorization requirement” due to the endocrine disrupting effects on the environment of DEHP.

Further information is available in the explanatory note.

EC Adopts Decision To Restrict Further Four Phthalates: The EC adopted on December 17, 2018, a decision to restrict the use of four phthalates (DEHP, DBP, BBP, and DIBP) in consumer products on the EU market. The restriction decision was adopted by amending REACH Annex XVII. According to the EC, the four phthalates are found in a wide variety of articles as they are commonly present in plasticized materials. Exposure may occur through the ingestion of food and dust, the placing of articles in the mouth, the inhalation of air and dust in indoor environments, and contact of dust and articles with human mucous membranes and skin. The amended Annex XVII entry includes the following restrictions:

  • DEHP, DBP, BBP, and DIBP shall not be used as substances or in mixtures, individually or in any combination, in a concentration equal to or greater than 0.1 percent by weight of the plasticized material in toys and childcare articles;
  • DEHP, DBP, and BBP shall not be placed on the market in toys or childcare articles, individually or in any combination, in a concentration equal to or greater than 0.1 percent by weight of the plasticized material;
  • DIBP shall not be placed on the market after July 7, 2020, in toys or childcare articles, individually or in any combination with DEHP, DBP, and BBP, in a concentration equal to or greater than 0.1 percent by weight of the plasticized material; and
  • DEHP, DBP, BBP, and DIBP shall not be placed on the market after July 7, 2020, in articles, individually or in any combination, in a concentration equal to or greater than 0.1 percent by weight of the plasticized material in the article. This restriction shall not apply to:
    • Articles exclusively for industrial or agricultural use, or for use exclusively in the open air, provided that no plasticized material comes into contact with human mucous membranes or into prolonged contact with human skin;
    • Aircraft, placed on the market before January 7, 2024, or articles, whenever placed on the market, for use exclusively in the maintenance or repair of those aircraft, where those articles are essential for the safety and airworthiness of the aircraft;
    • Motor vehicles within the scope of Directive 2007/46/EC, placed on the market before January 7, 2024, or articles, whenever placed on the market, for use exclusively in the maintenance or repair of those vehicles, where the vehicles cannot function as intended without those articles;
    • Articles placed on the market before July 7, 2020;
    • Measuring devices for laboratory use, or parts thereof;
    • Materials and articles intended to come into contact with food within the scope of Regulation (EC) No 1935/2004 or Commission Regulation (EU) No 10/2011 (*1);
    • Medical devices within the scope of Directives 90/385/EEC, 93/42/EEC or 98/79/EC, or parts thereof;
    • Electrical and electronic equipment within the scope of Directive 2011/65/EU; and
    • The immediate packaging of medicinal products within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC or Directive 2001/83/EC.

BPC Supports Union Authorization And Seven Active Substance Approvals: On December 18, 2018, ECHA issued a press release entitled “Biocidal Products Committee [(BPC)] concludes on a Union authorisation for disinfectants.” In the press release, ECHA indicates that the BPC supported an application for Union Authorization and seven active substance approvals. ECHA provides that the BPC adopted an opinion supporting an application for Union Authorization for a biocidal product family based on iodine used in veterinary hygiene for the disinfection of the teats of milk-producing animals (product-type (PT) 3).

The BPC also supported approval of the following active substances:

  • Silver zinc zeolite for use in disinfectants and preservatives (PTs 2, 7, and 9);
  • Silver zeolite for use in preservatives (PT 9);
  • Silver copper zeolite for use in preservatives (PT 9);
  • Silver sodium hydrogen zirconium phosphate for use in preservatives (PT 9);
  • Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC) for use in disinfectants (PTs 3 and 4);
  • Didecyldimethylammonium chloride (DDAC) for use in disinfectants (PTs 3 and 4); and
  • Icaridin for use in insect repellents (PT 19).

ECHA indicates that the evaluating Member States will need to assess the active substances against the new criteria for endocrine-disrupting properties before the Committee adopts its final opinions. The EC, together with EU Member States, will make final decisions on the Union Authorization and approval of the active substances. Further information is available in the Annex to ECHA’s press release.

Upcoming Inspections Will Check Compliance With REACH Registration Obligations: ECHA announced on January 9, 2019, that inspectors, working together with customs authorities, have begun checking the compliance of importers and manufacturers with REACH registration obligations as part of an EU-wide Forum enforcement project. The inspections are part of REACH-EN-FORCE-7 (REF-7) during which cooperation with customs authorities to check imports of substances is expected. The project aims to ensure EU-wide enforcement of the obligations of importers and manufacturers to register their substances, given that the last registration deadline passed in 2018. Checks will cover imported and manufactured substances in all tonnage bands, the main focus being on substances imported or manufactured in quantities of 1-100 tonnes per year. The inspections will also include a check of parts of the registration dossier and of other duties related to registration, for example, whether the registrant is compliant with the duty to update a registration dossier. Inspectors in EU Member States will verify whether substances registered as intermediates meet the definition of intermediates and are manufactured and used under strictly controlled conditions. In addition, substances registered as monomers in polymers will be checked. The inspection activities will continue throughout 2019. A report on the results of the inspections will be available in the fourth quarter of 2020. More information is available in ECHA’s January 9, 2019, press release, “Upcoming inspections to check compliance with REACH registration obligations.”

ECHA Announces Reorganization: ECHA announced on January 10, 2019, that it has realigned its organization to help it meet future challenges. The new organizational structure entered into force on January 1, 2019, after the adoption of the revised ECHA strategy by the Management Board in December 2018. The new structure reflects ECHA’s broad capacity to implement chemicals legislation, including information submission; dissemination, data mining, grouping, and prioritizing chemicals; assessing chemical hazards and exposure; and risk management and socio-economic analysis. ECHA states that the reorganization will allow it to focus on its strategic priorities, work more efficiently and flexibly, and make the best use of staff competences to take on new tasks. According to ECHA, one new director and a number of new heads of unit will be appointed in the new organization. The recruitment process is “currently ongoing.”

Six New Substances Added To SVHC Candidate List: On January 15, 2019, ECHA issued a press release entitled “Six new substances added to the Candidate List.” In its press release, ECHA provides that five new substances have been added to the Candidate List due to the carcinogenic, toxic to reproduction, persistent, bioaccumulative, and toxic (PBT), and very persistent and very bioaccumulative (vPvB) properties of the substances. One further substance has been added to the Candidate List, having been identified as a SVHC by the EC due to its endocrine-disrupting properties. The Candidate List of SVHCs for Authorization now contains 197 substances.

The decision to include four PAHs in the Candidate List was taken with the involvement of the Member State Committee (MSC). The four PAH cases were referred to the MSC to address new hazard information submitted during the public consultation. The following substances were added to the Candidate List:

  • 2,2-bis(4′-hydroxyphenyl)-4-methylpentane — Toxic for reproduction (Article 57(c));
  • Benzo[k]fluoranthene — Carcinogenic (Article 57(a)), PBT (Article 57(d)), and vPvB (Article 57(e));
  • Fluoranthene — PBT (Article 57(d)) and vPvB (Article 57(e));
  • Phenanthrene — vPvB (Article 57(e));
  • Pyrene — PBT (Article 57(d)) and vPvB (Article 57(e)); and
  • 1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one — Endocrine disrupting properties (Article 57(f)).

ECHA Will Provide OEL Recommendations: ECHA announced on January 21, 2019, that it signed an agreement with the EC to provide recommendations on a regular basis for occupational exposure limits (OEL) that protect workers exposed to hazardous chemicals. Under the agreement, ECHA will prepare scientific dossiers proposing four to five OELs per year from 2020 onwards. ECHA states that the new program of OEL development will start right away, “most likely with lead as the first priority at the request of the Commission’s DG Employment.” ECHA’s Secretariat will make proposals for RAC to review and on which to adopt scientific opinions. ECHA will forward the opinions to the EC for decision-making. ECHA notes that there is also the potential for it to support the EC further by assessing the socio-economic impacts in parallel to developing the OELs. ECHA’s pilot project delivered five OEL recommendations within one year, and they are currently passing through the decision-making process of the EC. Based on the experience from the pilot, ECHA will ensure an open and transparent process through public consultations. More information is available in ECHA’s press release, “ECHA to provide recommendations for occupational exposure limits.”

EC Evaluates Performance Of FCM Legislation: The EC has initiated a process to evaluate and likely revise the EU framework addressing the regulation of food contact materials (FCM). Regulation (EC) No 1935/2004 (Regulation) provides this framework and has done so since its adoption in October 2004 with varying degrees of success given the divergence of national standards sprinkled throughout the EU. The framework provides for special rules on active and intelligent materials; powers to enact additional EU measures for specific materials; a procedure to perform safety assessments of substances used to manufacture FCMs involving the European Food Safety Authority (EFSA); rules on labeling, including an indication for use, either by language or the appropriate symbol; and compliance documentation and traceability. The EC has wisely (and bravely given the complexity of the process) concluded there is a need to evaluate how the current Regulation has performed in relation to its original objectives, which were (1) to facilitate the free movement of FCMs and articles within the European Economic Community (EEC); and (2) to expand the scope of the previous legislation (Directives 80/590/EEC and 89/109/EEC) to include new types of materials and articles such as active ingredients and intelligent food contact materials, “for reasons of clarity and legal certainty,” all while protecting public health and the interests of consumers. Acta’s full memorandum, “EC Evaluates Performance of FCM Legislation: What You Need to Know and How to Respond,” provides more information on the Joint Research Center baseline study, the EC’s roadmap for the evaluation of FCMs and stakeholder workshop held in September 2018, the stakeholder consultation, and a commentary.


Mexico Promulgates New Regulation for Household Cleaning Products: On December 3, 2018, the Comisión Federal de Protección Contra Riesgos Sanitarios. (Federal Commission for the Protection Against Sanitary Risks (COFEPRIS)) has issued NOM-189-SSA1/SCFI-2018, “Productos y Servicios. Etiquetado y Embalaje Para Productos de Limpieza del Hogar” (Products and services. Labeling and Packaging for Household Cleaning Products (NOM-189)). NOM-189 speaks specifically to “soaps, detergents, cleaners, bleaches, starches for external use, stain removers, disinfectants, deodorants and environmental flavorings, and others of an analogous nature,” and is directed to “establish the health and commercial information requirements for the labels of household cleaning products in order to choose a better purchase option, as well as the sanitary characteristics for their packaging and thus avoid their use representing a risk.”

In part, NOM-189 sets out requirements for generic and specific product names, mandating that the generic name must be “established by reference to the presentation or function of the product,” and the specific name must be “established by reference to the place where the product will be applied” (Section 6.1.1). Furthermore, for products produced within Mexico, “the name, denomination or company name and address (street, number, postal code, city and state) of the producer or person responsible for manufacturing must be included” (Section 6.1.2). For imported products, the importer may provide this information to COFEPRIS.

Section 6.1.3, “Declaration of the List of Ingredients” requires that such must “appear on the information surface of the primary packaging” and that the “corrosive, toxic or flammable ingredients that give rise to the precautionary legends must be declared with the chemical or technical name most commonly used,” while Section 6.1.6 sets out the “precautionary legends” (pictograms) that must appear on the product label.

Various other requirements relating to packaging, commercial labeling, and country of origin are also found within NOM-189.


Registrations Under Amended K-REACH Due June 30, 2019: The amended Act on Registration and Evaluation, etc of Chemical Substances (K-REACH) came into effect on January 1, 2019. All existing chemical substances (i.e., substances that are listed on the existing chemical inventory in South Korea) manufactured in or imported to South Korea at greater than or equal to one ton per year are now subject to registration.

Existing chemical substances must be pre-registered prior to registration and pre-registration must be completed by June 30, 2019. Pre-registered substances benefit from registration grace periods that allow existing chemical substances to be imported without full registrations.

Substance TypeRegistration Deadline
>1,000 t/y existing substances
>1 t/y CMR substances
December 31, 2021
100-1,000 t/y existing substancesDecember 31, 2024
10-100 t/y existing substancesDecember 31, 2027
1-10 t/y existing substancesDecember 31, 2030

As reported in Acta’s October 25, 2018, Global Regulatory Update, on October 16, 2018, South Korea submitted two notices to the World Trade Organization (WTO). The first notice concerned carcinogenic, mutagenic or reprotoxic (CMR) substances that must be registered by December 31, 2021, if manufactured or imported in quantities greater than one ton per year. South Korea published the final notice on December 28, 2018. The notice lists only 364 CMR substances compared to the 544 CMR substances in the WTO notification. The second notice submitted to WTO concerned the designation of priority management substances. MOE published the final notice on December 28, 2018. The notice includes two lists of 672 substances. Notification of products containing the priority management substance is required if the quantity is above one ton per year and the content exceeds 0.1 percent weight by weight. The first list will be implemented in July 2019, and the second list in July 2021.

More information on the upcoming registration deadline is available in Acta’s January 14, 2019, memorandum, “Information on the Upcoming Registration Deadline for Chemical Substances in South Korea — June 30, 2019.”


President Signs Bill Amending The Toxic Chemical Substance Control Act: The full legislature passed on December 21, 2018, a bill amending the Toxic Chemical Substance Control Act. During the review by the Social Welfare, Health, and Environmental Protection Affairs Committee (Committee), the Committee revised the bill to include the creation of a National Chemical Substances Control Board. Under the legislation, the Board will be tasked with policy related to chemical substances; decision-making; and cross-ministerial policy coordination. The Committee also revised the legislation to strengthen the toxic chemical disaster response and reporting systems, and improve the insurance and liability provisions. Under the bill, the Toxic Chemical Substance Control Act will be renamed the Toxic and Chemical Substances of Concern Control Act. A rider to the legislation calls for the Taiwan Environmental Protection Administration (Taiwan EPA) to draft a bill within one year to regulate the existing chemicals manufactured, imported, and used in Taiwan. Once the legislation is signed into law, Taiwan EPA is expected to review over 30 subordinate laws and proposed updates as necessary. President Tsai Ing-wen signed the Toxic and Chemical Substances of Concern Control Act on January 16, 2019.


Additional Guidance Published On UK REACH: On December 4, 2018, the UK released a document entitled “UK REACH additional guidance if there is no Brexit deal.” The additional guidance “expands on, and should be read in conjunction with,” the Technical Notice published previously for businesses to prepare “for the possibility of no deal.” The additional guidance provides that in the event of no deal, the EU’s REACH regulation will be brought into UK law by the EU (Withdrawal) Act 2018. The guidance states “[w]e will therefore retain the key principles of the EU REACH Regulation, including its fundamental principle of ‘no data, no market,’ and its provision for Only Representatives [(OR)].” The guidance refers to the “EU REACH Regulation, as amended,” as the UK REACH Regulation, and contains references to EU REACH provisions as the Draft Statutory Instrument for UK REACH, addressed below, was not available when the additional guidance was published.

The additional guidance provides that in the event of a no deal Brexit, roles undertaken by companies under EU REACH may change significantly. The guidance emphasizes the importance of reviewing roles “within the EU and UK REACH regimes.” For existing EU REACH registration holders, the additional guidance provides:

  • “In order to continue exporting substances or mixtures to the EU/EEA market, UK-based entities currently holding EU REACH registrations would need to transfer their registrations to an EU/EEA-based entity, or support their EU/EEA-based importers to become registrants.”
  • Entities currently holding EU REACH registrations would need a valid UK REACH registration to maintain access to the UK market.

The additional UK REACH guidance addresses downstream users, authorization, restrictions, ORs, UK REACH-IT, new registrations, and the following scenarios:

  •  Scenario 1: You are a UK-based EU REACH registration holder wishing to maintain UK market access;
  • Scenario 2: You are a UK-based downstream user or a distributor of an EU REACH registered chemical and wish to maintain UK market access;
  • Scenario 3: You are a UK importer of chemicals from outside the EU/EEA, or rely on a UK importer for your supply from outside the EU/EEA, and wish to maintain EU/EEA market access;
  • Scenario 4: You are a UK-based REACH authorization holder wishing to maintain your use or the supply for a use in the UK;
  • Scenario 5: You are a UK downstream user of a REACH authorization held by an EU/EEA-based company, wishing to maintain your use or the supply for a use in the UK;
  • Scenario 6: You are exempt through product and process orientated research and development (PPORD); and
  • Scenario 7: You are awaiting an ECHA or EC decision.

The appendices to the additional guidance include information regarding: (1) “[g]randfathering data submission requirements”; (2) grandfathering data submission requirements for intermediates; and (3) notification requirements for UK downstream users and distributors of EU REACH registered chemicals.

Government Publishes Draft UK REACH Statutory Instrument: The UK Government has published a Draft Statutory Instrument entitled “The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019.” The Draft Statutory Instrument for UK REACH portrays the regulatory framework in the form of amendments to the EU’s REACH regulation, and provides details regarding registrations, authorizations, the UK chemicals agency, and other UK REACH matters.

As an example of how the Draft Statutory Instrument addresses post-Brexit chemicals management, Article 2A(1) states:

  • “The functions and powers of the Agency under the REACH legislation are to be functions and powers of the [Health and Safety Executive (HSE)].”
  • “Accordingly, any reference to the Agency in the REACH legislation must be read as meaning the HSE.”

Under Article 127A of the Draft UK REACH Statutory Instrument, existing EU REACH registrations have the effect on and after exit day as UK registrations if the registration: (1) has a current connection with the UK; or (2) “has a relevant past connection with the UK (but does not have a current connection with the UK).” Under the draft text, registrations are considered to have a current connection with the UK if: (1) the registrant immediately before exit day is a person established in the UK; and (2) “a registration of the substance concerned by the current UK registrant is a registration of a kind that could be submitted on exit day under Articles 6, 7(1) or 7(5) of this Regulation.” Requirements for “a relevant past connection with the UK” include that “the registrant at any time during the [two] year period before exit day was a person established in the [UK].”

Under Article 127B(4), transferring UK registrants must submit to the HSE:

  • Information referred to in REACH Article 10(a)(i), (ii), and (iii), and any relevant indication under Article 10(a)(viii), within the 60 day post-exit period; and
  • The other Article 10 information within the two year post-exit period.

Under the Draft Statutory Instrument, existing EU REACH authorizations granted to UK companies will continue to have effect in the UK post-Brexit, subject to certain “technical information” requirements. Additional information is available in the UK REACH Impact Assessment and the Regulatory Policy Committee’s Report on the Draft UK REACH Statutory Instrument.

House Of Commons Votes Against “Brexit Deal” And Government Survives No-Confidence Vote: On January 15, 2019, the UK’s House of Commons voted on the “Brexit Deal” (i.e.Draft Withdrawal Agreement) negotiated between the UK and the EU. UK Members of Parliament (MP) voted, by 432 votes against 202 votes, to reject the Brexit Deal proposed by UK Prime Minister Theresa May. The Brexit Deal rejected in the House of Commons, which was the work product of over two years of UK-EU negotiations, set out the terms for the UK’s departure from the EU and proposed a 21-month transition period. This vote in the House of Commons was originally due to occur in December 2018, but was delayed by Ms. May in an effort to gain greater support from MPs.

The House of Commons vote is an important step in the Brexit process, and its result has been described as “the largest defeat for a sitting government in history.” The results of the vote indicate that the Brexit debate has cut across traditional party lines, with 118 Conservative MPs from both Leave and Remain wings voting with opposition parties against Ms. May’s proposed Brexit Deal. Meanwhile, three Labor MPs supported Ms. May’s Brexit Deal. Ms. May indicated that an alternative Brexit plan would be proposed in the House of Commons if the UK Government survived the no-confidence vote, addressed below.

Among the key sticking points in the House of Commons was the issue of the Northern Irish “backstop.” In the debate leading up to the vote on the Brexit Deal, MPs expressed their views that insufficient progress was made in terms of the backstop. Ms. May presented to the House recent assurances from EU leaders in this regard, providing that the backstop would last for “the shortest possible period.” The Northern Irish backstop continues to be one of the most challenging Brexit issues in terms of reaching arrangements that will meet the expectations of all interested parties.

Ms. May has indicated that she remains committed to delivering on the results of the 2016 referendum, and that the Government would explore ideas from cross-party discussions with the EU. Importantly, EC President Jean-Claude Juncker stated:

The risk of a disorderly withdrawal of the [UK] has increased with [the House of Commons] vote … While we do not want this to happen, the [EC] will continue its contingency work to help ensure the EU is fully prepared … I urge the [UK] to clarify its intentions as soon as possible … Time is almost up.

Following the MPs’ vote on the Brexit Deal, Jeremy Corbyn, Leader of the Labor Party, initiated a vote of “no-confidence” in Ms. May’s government. MPs voted on the matter of no-confidence in Ms. May’s administration on January 16, 2019, and the UK Government survived the no-confidence proposal by 325 votes to 306 votes.

Ms. May invited leaders of all UK political parties, including Labor, Liberal Democrats, and Plaid Cymru, to have individual meetings in “constructive spirit” with her on the way ahead for Brexit. Ms. May stated “[w]e must find solutions that are negotiable and command sufficient support in this House.” Mr. Corbyn indicated in the House of Commons that before any “positive discussions” involving Labor could take place, a “no-deal Brexit” should be ruled out by Ms. May.

CIA And Cefic React To House Of Commons Vote On Brexit Deal: The significance of the vote in the House of Commons on Ms. May’s proposed Brexit Deal has caused various organizations in the chemicals sector, including the Chemical Industries Association (CIA) and the European Chemical Industry Council (Cefic), to issue comments in this regard. On January 16, 2019, CIA issued a press release entitled “Chemical industry reacts to MP’s vote on Brexit deal.” In the press release, Steve Elliott, Chief Executive of CIA states:

There is of course general business disappointment with the current position. We continue to lack the certainty that business has called for since the day after the 2016 referendum, in order that investment decisions can be made …. Parliament has spoken. Whether we like it or not, what happened last night was a political process as part of a democracy. It is not for businesses to interfere in that process. What we can and what we have responsibility to do, is to advise of the consequences, and those consequences — in terms of contingency plans and actions — are becoming more and more critical as we get closer to our 29 March exit from the EU. Every delay risks either no decision on UK investment, trade and jobs or, worse than that, irreversible decisions.

In its press release, CIA emphasizes that the chemicals sector continues to call for minimal disruption, and that the “whole industry” seeks frictionless free trade, regulatory consistency, and access to skilled people. Following the vote in the House of Commons, Cefic issued a press release entitled “European chemical industry’s statement on outcome of Brexit vote.” In its press release, Cefic states “[f]ollowing yesterday’s vote in the UK Parliament, business continues to lack clarity about the state of play after 29March 2019, which means that companies cannot make decisions on production, investments and employment.” Marco Mensink, Director General of Cefic, stated “[w]e can’t stress this enough, because having certainty on the arrangements between the EU and the UK is critical to avoid serious supply chain disruptions. We continue to ask for a solution to be found, and hope that a ‘no-deal Brexit’ can still be avoided.”

Similar to the comments from CIA, Cefic indicates in its press release that the chemical industry on “both sides of the Channel” has been “calling,” from the onset of Brexit negotiations, for an agreement that would: (1) keep frictionless tariff-free trade in chemicals; (2) ensure regulatory consistency between the UK and EU-27; and (3) enable access to skilled people to continue with the chemicals sector’s research and development programs.