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August 1, 2018

Global Regulatory Update for August 2018

The ACTA Group

PRE-ORDER NOW “Chemical Regulation in the Middle East” by Michael S. Wenk, M.S.

Chemical Regulation in the Middle East,” written by Michael S. Wenk, M.S., Senior Regulatory Consultant with Bergeson & Campbell, P.C. and The Acta Group, offers an essential guide to the patchwork of chemical regulatory programs and the complex system of permits and licenses that manage chemicals in the countries of the Middle East. The book explores the range of ministry, legislative, and other decrees that encompass pesticides, occupational safety and health, as well as safety data sheets and product labels that address regulation to widely-varying degrees.


Restriction Of Hazardous Substances Law Moves Forward: The Brazilian Ministerio de Medio Ambiente (Ministry of Environment; MMA) has announced that the data received as part of its request for information from manufacturers and importers of electronic equipment will be considered in the development of the Authority’s late-2018 Restriction of Hazardous Substances (RoHS) regulation.

Brazilian Congress Takes Multiple Plastics Legislation: A pair of bills has been brought forward in the Brazilian Congress to regulate single-use plastics for consumer use. A bill in the lower house, the Câmara dos Deputados (Chamber of Deputies), Draft Law No. 10346/2018, “Cria regra para redução progressiva da utilização de plástico como matéria-prima de produtos de uso único” (“Creates rule for progressive reduction of the use of plastic as a raw material for single use products”), would develop a program to guide Brazil away from using plastic as the main raw material for single-use products, and to more sustainable and/or more environmentally-friendly ones.

A second bill in the Câmara dos DeputadosDraft Law No. 10409/2018, “Determina a progressiva redução e eliminação da produção, comercialização e importação de produtos plásticos descartáveis para uso único e outras medidas” (“Determines the progressive reduction and elimination of the production, commercialization and importation of disposable plastic products for single use and other measures”), would set forth requirements for progressively reducing, with the ultimate goal of elimination, the production, import, and sale of single-use plastics.


Canada Commits To Reforming CEPA: On June 29, 2018, the Minister of Environment and Climate Change and the Minister of Health submitted the Follow-Up Report to the House of Commons Standing Committee on Environment and Sustainable Development on the Canadian Environmental Protection Act, 1999. The Follow-Up Report describes the many areas where the government is committed to taking further action in the near-term. In its June 29, 2018, press release, Environment and Climate Change Canada (ECCC) states that the government is taking action to implement many of the Committee’s recommendations:

  • It is working to enhance how it protects vulnerable populations, including by developing a policy framework for considering vulnerable populations — such as children, pregnant women, and the elderly — in the assessment and management of chemicals;
  • It is taking action to protect Canadians from chemicals of high concern, such as endocrine disruptors, which can affect how hormones work and lead to long-term health issues; and
  • It is updating standards and developing new instruments to improve air quality and reduce air pollution from industrial sources, including oil refineries.

To address recommendations that require legislative reform, the press release states that ECCC will conduct a thorough review and consult widely with Canadians as it works toward updating Canada’s Chemicals Management Plan (CMP) and overhauling the Canadian Environmental Protection Act, 1999 (CEPA) through amendments in a future Parliament.


Chile Also Seeks To Regulate Single-Use Plastics: Similar to the Draft Laws pending in Brazil reported above, on June 12, 2018, the lower house of the Chilean Congress, the Cámara de Diputados (Chamber of Deputies), put forth Bill No. 11802-12 (the Bill). The “Prohíbe el uso de envases y embalajes plásticos en la comercialización de productos destinados al consumidor final” (“Prohibits the use of plastic containers and packaging in the marketing of products intended for the final consumer”) would set out a schedule to remove plastics from containers and related packaging designed for the end-use consumer. Per Section 1 of the Bill, it is designed as a corollary to Bulletin No. 9133-12, “Prohíbe la entrega de bolsas plásticas de comercio en todo el territorio nacional” (“Prohibits the delivery of plastic bags of commerce throughout the national territory”), that laid the groundwork for ending the use of plastic bags in the country. Interestingly, in the same section, the Congress notes it derives its authority for both the Bill and the Bulletin from Article 19, No. 8 of the Chilean Constitution. Specifically, “[t]he right to live in a pollution-free environment. It is the duty of the State to ensure that this right is not affected and to protect the preservation of nature[.] The law may establish specific restrictions on the exercise of certain rights or freedoms to protect the environment.”


Costa Rican Authority Decree Speaks To Pesticide Product Fees: The Costa Rican Ministerio de Salud (Ministry of Health) has recently promulgated Decree No. 41117-S, “Reglamento para la recopilación de procedimientos de registro y control de plaguicidas para uso doméstico y profesional” (“Regulation for the collection of procedures for registration and control of pesticides for domestic and professional use”). Per Article 1, the Decree “is to regulate the collection [of various fees] to be made by the Ministry of Health for the services it provides related to registration, renewal of the registry, subsequent changes to registration, control and monitoring of pesticide products for domestic and professional use…” Chapter II specifically enumerates the fees “for registration and control services of household pesticides or for professional use” in tabular format.


EC And Online Marketplaces Sign Product Safety Pledge: The European Commission (EC) announced on June 25, 2018, that it signed a Product Safety Pledge with four major online marketplaces — Alibaba Group (for AliExpress), Amazon, eBay, and Rakuten-France. According to the EC, online sales represented 20 percent of the total sales in 2016 in the EU (Eurostat), and more of the dangerous products notified in the Rapid Alert System are sold online. The online marketplaces commit to taking the following measures:

  • React within two working days to authorities’ notices made to the companies’ contact points to remove listings offering unsafe products;
  • Provide a clear way for customers to notify dangerous product listings. Such notices are treated expeditiously and appropriate response is given within five working days;
  • Consult information on recalled/dangerous products available on the EU Rapid Alert System for dangerous non-food products and also from other sources, such as from enforcement authorities and take appropriate action with respect to the products concerned, when they can be identified;
  • Provide specific single contact points for EU Member State authorities for the notifications on dangerous products and for the facilitation of communication on product safety issues;
  • Take measures aimed at preventing the reappearance of dangerous product listings already removed; and
  • Provide information/training to sellers on compliance with EU product safety legislation, require sellers to comply with the law, and provide sellers with the link to the list of EU product safety legislation.

The online marketplaces and the EC will assess the progress made on the commitments every six months, publishing a report. The EC “encourages other online marketplaces to follow the good example of the four companies taking the lead today and sign up and contribute to improving product safety online for consumers in the EU.”

ECHA Announces Enforcement Project Will Concentrate On Online Sales Of Chemicals: The European Chemicals Agency (ECHA) announced on June 25, 2018, that the eighth major Forum for Exchange of Information on Enforcement enforcement project (REF-8) will concentrate on online sales of substances, mixtures, and articles. According to ECHA, one reason for this focus is the high rate of non-compliance detected in the Forum’s pilot project on Internet sales. The scope of REF-8 is expected to include restrictions and labeling duties for hazardous chemicals. ECHA states that the project will be prepared in 2019 and carried out in 2020, with the report expected to be published by the end of 2021.

During the Forum’s June 19-20, 2018, meeting, the Forum also agreed that inspections for the pilot project on authorization focusing on chromium VI compounds and other substances will take place in 2020. ECHA states that this will allow inspectors to target more substances and give downstream users sufficient time to notify their authorized uses to ECHA. The inspectors will target companies that are using substances of concern without the required authorization. Additionally, they will check that authorization holders and their downstream users comply with the conditions of the authorisation decision. More information is available in ECHA’s press release, “Inspectors to check internet sales of chemicals.”

Ten New Substances Added To Candidate List Of SVHCs: On June 27, 2018, ECHA issued a press release entitled “10 new substances added to the Candidate List.” The Candidate List of substances of very high concern (SVHC) contains 191 entries following addition of these substances.

The press release provides that “ECHA has added eight new SVHCs to the Candidate List following the SVHC identification process with the involvement of the Member State Committee (MSC) … Two further substances, [Benzene-1,2,4-tricarboxylic acid 1,2 anhydride (trimellitic anhydride) (TMA)] and [Dicyclohexyl phthalate (DCHP)], have also been added to the list, having been identified as SVHCs by the European Commission due to their respiratory sensitising properties and toxic for reproduction and endocrine-disrupting properties, respectively. The Commission’s decision follows the referral of the MSC opinions on these SVHC proposals in 2016.”

The following substances were added to the Candidate List on June 27, 2018:

  • Octamethylcyclotetrasiloxane (D4);
  • Decamethylcyclopentasiloxane (D5);
  • Dodecamethylcyclohexasiloxane (D6);
  • Lead;
  • Disodium octaborate;
  • Benzo[ghi]perylene;
  • Terphenyl, hydrogenated;
  • Ethylenediamine (EDA);
  • TMA; and
  • DCHP.

ECHA And Eurometaux Agree On Cooperation Framework: On June 29, 2018, ECHA issued a press release entitled “ECHA and Eurometaux agree on Framework for Cooperation.” ECHA’s press release states “ECHA’s Executive Director Bjorn Hansen and Eurometaux’s Guy Thiran have signed the Metals and Inorganics Sectorial Approach (MISA) agreement providing a cooperation framework for improving the data in the registration dossiers for these substances and advancing technical and scientific issues related to metal compounds and inorganic substances.”

By the end of 2020, ECHA and Eurometaux aim to identify shortcomings in information under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labelling, and Packaging (CLP) regulations pertaining to metal compounds and inorganic substances. The MISA Agreement aims to generate further information on as many metal compounds and inorganics as possible, and to improve supply chain communication and identify new risk management needs.

The MISA framework signed by ECHA and Eurometaux will be followed by bilateral signatures with participating consortia. ECHA states “[b‌]y signing up to this framework and [the] related action plan, the participating industry sectors [recognize] the importance of providing accurate and clear information on hazards, risks and conditions of safe use throughout the supply chain.” The MISA Agreement is in line with ECHA’s Integrated Regulatory Strategy, and the cooperation will contribute to achieving the objectives of the 2020 Strategic Approach to International Chemicals Management (SAICM).

ECHA and Eurometaux issued a Joint Statement, which provides that “[b‌]oth ECHA and Eurometaux commit to engage the necessary resources to support the action plan that [is] focused on two equally important parallel tracks”:

  • Track 1: A gradual and planned improvement of the compliance, quality, and understanding of the metals/inorganics registration dossiers; and
  • Track 2: To resolve outstanding technical and methodological issues that will allow to improve the relevance of hazard, risk assessment, and risk management of metals and inorganics.

The Joint Statement provides that ECHA and Eurometaux will “ensure an open and transparent communication on the goals, priorities and progress made with the MISA general [program].” Additional information is available in the MISA Rolling Action Plan.

ECHA’s BPC Concludes On Union Authorization And Active Substances: On June 29, 2018, ECHA issued a press release entitled “Biocidal Products Committee concludes on a Union authorisation for disinfectants.” In the press release and related Annex, ECHA provides that the Biocidal Products Committee (BPC) “concluded favourably on an application for Union authorisation for a product family containing iodine/PVP-iodine.” This EU authorization request relates to disinfection in veterinary hygiene, product-type 3.

Regarding active substances, the BPC supported approval of DBNPA for use in disinfectants (product-type 4). The biocidal products containing DBNPA are intended to be used for disinfection in food processing (e.g., industrial mayonnaise- or yoghurt-producing facilities). The disinfection and processing exclusively takes place in industry, and only industrial workers may come into contact with DBNPA. The evaluating Member State, Denmark, has been requested to assess whether the active substance meets the new criteria for endocrine-disrupting properties before the Committee adopts its opinion on the active substance.

The BPC could not conclude on the proposal for chlorfenapyr for use in pest-control products (product-type 18), and therefore a revised proposal will need to be submitted to the Committee. The biocidal products containing chlorfenapyr are intended to be used for the control of ants. The products are used for surface treatment indoors by spraying, or for spraying structures and their immediate surroundings outdoors, by professional operators. The evaluating competent authority for the active substance application is Portugal.

Following a request from the EC, the BPC also adopted an opinion on a product used for the temporary preservation of corpses. The Committee concluded that a substance in the product acts as an active substance in line with the definition set out in the Biocidal Products Regulation (BPR). The substance name is confidential. The EC and EU Member States will take the final decision on approval of these active substances and the abovementioned Union Authorization application.

ChemSec Issues Letter To Björn Hansen: On July 3, 2018, the International Chemical Secretariat (ChemSec) issued “A letter to Björn Hansen,” ECHA’s Executive Director. In the letter, Anne-Sofie Andersson, ChemSec’s Executive Director, states:

In your new position I expect that you will focus on making the agency’s work more efficient. I also hope that you will guide the agency towards a greater focus on human health and the environment. I ask this of you, because in the light of the REACH Review it is clear to me that REACH is not delivering at the pace that could be expected. This is a matter of serious concern.

What I find confusing and contradictory is that while the REACH review states that REACH has delivered too slowly, the ECHA progress report on the SVHC roadmap says something seemingly different: ‘all currently known relevant [SVHCs] have been addressed.’ The keyword here is relevant. Which substances are seen as relevant and which are not? And what does ECHA mean by ‘addressed?’

ChemSec provides that REACH clearly states that all substances identified as SVHCs shall be added to the Candidate List, and emphasizes the importance of the Candidate List in driving innovation and encouraging companies to explore possibilities for substitution. ChemSec refers to its report entitled “Pick up the Pace — SIN List Shows the REACH Process is Too Slow,” and criticizes ECHA’s report which “showed that only 7 of the 912 SIN substances on the SIN list need further scrutiny, when in fact only 174 substances were then on the Candidate List.”

ChemSec states that in reviewing REACH processes, it discovered that no single part or process can be “blamed for the slowness.” ChemSec’s letter further states “[m]any times it’s rather parts of industry that have succeeded in manufacturing doubt, resulting in a paralysis by analysis whereas the precautionary principle could have justified legal action.” ChemSec urges Hansen to “assure that ECHA will speed up the processes of addressing chemicals of high concern, look beyond the first round of priority criteria, and find ways to limit the paralysis.”

ChemSec poses the following specific questions to Hansen:

  • Do you agree that non-registered substances could also be relevant for the Candidate List?
  • In your view, are substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) adequately regulated through the requirements that apply following their classification?
  • What is your view on listing restricted substances on the Candidate List and vice versa?
  • What is your plan to assure that the discussions in the expert groups actually bring substances closer to the Candidate List and will not continue to serve as a way of keeping substances off the regulatory radar for a number of years?
  • How will ECHA assure that it resists industry pressure more effectively and sticks to the scientific hazard criteria for Candidate Listing?

In conclusion, Andersson states “I am looking forward to an ongoing discussion with you and ECHA on how to really address all relevant SVHCs.”

ECHA Issues Report On Board Of Appeal (BoA): ECHA has issued its “Annual Report from the Chairman of the Board of Appeal.” The report includes several sections, including “Key messages,” “Appeals in graphics,” and “Overview of 10 years of BoA work and its findings.” Among the Key Messages, the report states:

  • “BoA’s decisions have helped clarify the interpretation of REACH and the BPR and helped ensure their effective implementation by ECHA. After the adoption of more than 100 decisions, it is clear that BoA’s decisions are widely accepted by stakeholders, provide an effective legal remedy to appellants, and create a safety net to the Agency.”
  • BoA has raised the standards of good administration that ECHA has to observe as manager of REACH processes.
  • “The outcome of BoA decisions is balanced. 24.5% of cases are decided in favour of appellants and 24.5% of cases are dismissed. 51% of cases are closed following withdrawal of the appeal; in majority of these cases, either after the Executive Director has rectified the contested decision or the parties have settled the appeal.”
  • Feedback from industry on the operation of the BoA is positive overall.

The report includes results from the reporting period from June 10, 2017 – June 6, 2018. The report indicates that during this timeframe, the BoA processed 35 appeals; 17 of these cases were closed with a final decision, and 18 are ongoing. Eleven oral hearings were held in this period. The report provides that the average duration of an appeal is “close to 15 months.” In addition to the final decisions, many procedural decisions were adopted in the course of the proceedings. These include 12 decisions on intervention, two decisions on confidentiality, 11 decisions on stay of proceedings, and one decision joining the cases. The number of procedural measures prescribed by the BoA was “around 600,” and the number of incoming and outgoing documents registered in the Register of Appeals during the reporting period is “close to 900.”

During the reporting period, the BoA decided upon several new issues, including consolidation of a single registration into a joint submission, information requirements for nanomaterials, interaction between REACH and the Cosmetics Regulation, and whether ECHA can request “standard information” during substance evaluation. The report states “it should be noted that, almost all appeal cases that the BoA handles are legally and scientifically complex and relate to grey areas of REACH and the BPR. The BoA has to make high quality decisions, in a timely fashion for these appeal cases.”

Annex II of the report is entitled “Overview of 10 years of BoA work and its findings.” This section of the report addresses in detail the BoA’s achievements and important decisions in several areas, including REACH registration, data sharing, and compliance checks. Additional information regarding the BoA is available on ECHA’s website.

EFSA Publishes New Guidance On Nanotechnologies In Food And Feed: The European Food Safety Authority (EFSA) issued a July 4, 2018, press release announcing the availability of new guidance on how to assess the safety of nanoscience and nanotechnology applications. The guidance covers novel foods, food contact materials, food and feed additives, and pesticides, taking into account new developments that have taken place since publication of the previous guidance in 2011. The guidance specifically elaborates on the physicochemical characterization of nanomaterials in terms of how to establish whether a material is a nanomaterial, the key parameters that should be measured, the methods and techniques that can be used for characterization of nanomaterials, and their determination in complex matrices. The guidance also discusses nanospecific considerations relating to in vivo/in vitro toxicological studies, and outlines a tiered framework for toxicological testing.

ECHA Will Create New Database On Candidate List Substances In Articles: ECHA announced on July 11, 2018, that it will establish a new database on the presence of hazardous chemicals in articles by the end of 2019 for waste treatment operators and consumers. The database will comprise information submitted by companies producing, importing, or selling articles that contain Candidate List substances. Companies need to submit this information by the end of 2020. ECHA notes that the task is based on the revised waste framework directive that entered into force in July 2018 and is part of the EU’s waste legislation package. According to ECHA, the information will be available to waste treatment operators and consumers and should help waste operators in treating waste and recycling materials. The goal is to improve the risk management of chemicals during waste recovery and to promote non-toxic material cycles. The database will also aim to help consumers make informed choices for safer products, “increas[ing] pressure to substitute substances of concern.” More information is available in ECHA’s press release, “New database on Candidate List substances in articles by 2021.”

EC Takes Further Action To Improve Consumer Protection Against Four Phthalates: The EC announced on July 11, 2018, that it took action to restrict the placing on the market of articles containing four phthalates: bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP), and diisobutyl phthalate (DIBP). According to the EC, consumers can be exposed to these phthalates through different sources, such as ingesting food and dust, placing articles in the mouth, breathing in air and dust indoors, and by dust and articles getting in contact with mucous membranes and skin. The EC states that the phthalates are SVHCs known for their toxic effects on reproductive health. According to the proposed restriction unanimously approved by the REACH Committee, the four phthalates may not be present in articles used by consumers or available in indoor areas in a concentration equal to or above 0.1 percent by weight individually or in any combination in any plasticized material. The restriction proposal takes into account the cumulative effects and combined exposure to the phthalates from different articles. The European Parliament and the Council have three months to scrutinize the measure before its adoption by the EC. The restriction will then be published in the Official Journal of the European Union and will apply 18 months after the entry into force to products produced both in and outside of the EU.

EC Opens Comment Period On Draft Regulation Aligning CLP With GHS: On July 16, 2018, the EC published for comment a draft regulation that would align the CLP with the sixth and seventh revised editions of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). According to the draft regulation, the sixth and seventh revised editions of the GHS “trigger the need to amend some provisions” on classification, labeling, and packaging, “in particular regarding the generic cut-off values; the aerosol form of mixtures and the following hazard classes: explosives; flammable gases; flammable liquids; flammable solids; acute toxicity; skin corrosion/irritation; serious eye damage/eye irritation; respiratory and skin sensitisation; germ cell mutagenicity; carcinogenicity; reproductive toxicity; specific target organ toxicity; aspiration hazard as well as some hazard statements and precautionary statements.” The CLP introduced a new hazard class for desensitized explosives and a new hazard category, pyrophoric gases, and it is necessary to adapt some provisions and criteria in the CLP Annexes to the sixth and seventh revised editions of the GHS. Comments are due August 13, 2018.

EC Publishes Communication On Preparing For UK’s Withdrawal From The EU: On July 19, 2018, the EC published a Communication outlining the ongoing work on the preparation for all outcomes of the United Kingdom’s (UK) withdrawal from the EU. According to the EC’s press release, the Communication calls on EU Member States and private parties “to step up preparations and follows a request by the European Council (Article 50) last month to intensify preparedness at all levels and for all outcomes.” The EC states that the UK’s withdrawal “will undoubtedly cause disruption — for example in business supply chains — whether or not there is a deal.” The EC states that stakeholders, as well as national and EU authorities, need to prepare for two possible main scenarios:

  • If the Withdrawal Agreement is ratified before March 30, 2019, EU law will cease to apply to and in the UK on January 1, 2021i.e., after a transition period of 21 months; or
  • If the Withdrawal Agreement is not ratified before March 30, 2019, there will be no transition period and EU law will cease to apply to and in the UK as of March 30, 2019. This is referred to as the “no deal” or “cliff-edge” scenario.

The EC states that it has adopted (and will adopt whenever necessary) specific, targeted legislative proposals to ensure that EU rules continue to function smoothly in a Union of 27 after the UK’s withdrawal. The EC notes that it has also published over 60 sector-specific preparedness notices to inform the public about the consequences of the UK’s withdrawal in the absence of any Withdrawal Agreement. Finally, by March 30, 2019, the two London-based agencies — the European Medicines Agency and the European Banking Authority — as well as other UK-based bodies, like the Galileo Security Monitoring Center, will be leaving the UK and tasks performed by UK authorities will also be reassigned away from the UK.

EC Begins Public Consultation Addressing The Interface Between Chemical, Product, And Waste Legislation: On July 23, 2018, the EC began a public consultation addressing the interface between chemical, product, and waste legislation. In the introduction to the questionnaire, the EC notes that in its 2015 Circular Economy Action Plan, it announced its intention to analyze and prepare policy options to address the interface between chemical, product, and waste legislation. As part of the Circular Economy Package adopted in January 2018, the EC published the results of its work in this area in the form of a Communication and accompanying Staff Working Document. The Communication addresses four obstacles that impede the safe uptake of secondary raw materials: insufficient information about substances of concern in products and waste; presence of substances of concern in recycled materials and in articles made thereof; difficulties in applying end-of-waste criteria; and no clear application of EU waste classification methodologies. In addition to the objectives and actions that are set out in the Communication, the Staff Working Document describes the main challenges pertaining to the four issues and proposes options to tackle them. The main content of the questionnaire relates directly to the EC’s assessment of the Interface as described in the EC’s Communication and Staff Working Document. The questionnaire is directed to both specialists and non-specialists alike with the objective of assessing the reaction to the different options and questions posed in those documents. Responses are due by October 29, 2018.

ECHA Publishes Information From Notification Of Authorized Uses: Under REACH, if a company’s use of a substance on the Authorization List is covered by an authorization granted to their supplier, the company must notify ECHA of the continued use of the substance after its sunset date. ECHA announced in July 2018 that it has published a public register with data from the first notifications received in 2016. ECHA maintains the register and forwards the notifications to the relevant authorities in the EU Member States. ECHA has also published an overview of the reports submitted during the first half of 2018. Downstream users are required to report to ECHA if:

  • They prepare a chemical safety report (CSR) to assess a use not covered by the exposure scenario received from their supplier;
  • They rely on certain exemptions from the obligation to prepare a downstream user CSR; or
  • Their classification is different from that of all of their suppliers.


Mexican Authority Issues Official Standard Regulating Chemical, Pharmaceutical, Biological And Food Products For Animal Use Or Consumption: On July 14, 2018, the Mexican Ministerio de Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (Ministry of Agriculture, Livestock, Rural Development, Fisheries and Food; SAGARPA) put forth its “Proyecto de Modificación a la Norma Oficial Mexicana NOM-012-ZOO-1993, Especificaciones para la regulación de productos químicos, farmacéuticos, biológicos y alimenticios para uso en animales o consumo por estos” (“Draft amendment to Mexican Official Standard NOM-012-ZOO-1993, Specifications for the regulation of chemical, pharmaceutical, biological and food products for animal use or consumption”).

The Draft Amendment establishes specifications relating to the production, storage, distribution, commercialization, quality control, and verification of products for the use or consumption of livestock. The manifest purpose is to ensure the efficacy and safety of the veterinary biologics and feedstuffs registered with SAGARPA, by more closely regulating the control of the production process and the raw materials. Further, the Draft Amendment specifies that the information provided in the labeling of all chemical, pharmaceutical, biological, and food products must provide a guarantee as to their effectiveness and safety. The NOM is applicable to establishments engaged in the production, import, export, conditioning, storage, distribution, and marketing of products for animal use or consumption.

The Draft Amendment will be available for comment 60 days following its publication in the Diario Oficial de la Federación.


OECD Invites QSAR Toolbox Users To Participate In Survey: In June 2018, OECD invited (QSAR) Toolbox users to participate in a survey. According to OECD, to understand the breadth of current usage of the QSAR Toolbox and its main applications, the survey focuses on the extent of the QSAR Toolbox usage and the collection of case studies (examples) of QSAR Toolbox application in a regulatory context. The survey consists of two sets of questions:

  1. Case studies (examples) of the QSAR Toolbox application in a regulatory context; and
  2. General questions regarding use of the QSAR Toolbox.

OECD states that the collected case studies should illustrate the following elements: ensuring protection for human health and the environment; the use and promotion of alternative methods; and enhancing competitiveness and innovation. OECD will use the results of the survey to improve the functionality and service of the QSAR Toolbox, as well as to promote the usage of the QSAR Toolbox in the regulatory context. Responses are due September 15, 2018.


Peru Considers Polymer Reduction Regulation: The Peruvian Congress is considering Bill No. 02976/2017-CR that would outline progressive and voluntary provisions for reduction of single-use polymers and their derivatives. The Bill is entitled “Ley De Reducción Progresiva Y Voluntaria Del Uso De Polímeros De Un Solo Uso Y Sus Derivados” (“Law Of Progressive And Voluntary Reduction Of The Use Of Single-Use Polymers And Their Derivatives”).


U.S. Responds To WTO TBT Notification Of Revised K-REACH Enforcement Decree And Rules: The U.S. World Trade Organization (WTO) delegation circulated a June 20, 2018, statement regarding South Korea’s June 11, 2018, Technical Barriers to Trade (TBT) notification of the revised Act for the Registration and Evaluation of Chemicals (K-REACH) enforcement decree and rules. The U.S. asks that the January 1, 2019, implementation date be delayed to allow companies adequate time to prepare. The U.S. “strongly encourage[s]” the issuance of English translations and comprehensive guidance in English for all industry stakeholders. According to the U.S., while South Korea has stated that companies can apply to the Ministry of the Environment (MOE) for confidential treatment of some information, U.S. industry reports that MOE is denying most confidential business information (CBI) claims. The U.S. is also concerned about MOE’s recent proposal for amendments to the Chemical Control Act and Presidential decrees to introduce a mandatory tracking and reporting system for chemicals from import to manufacturing and end-use. The proposed amendments “would impose a heavy new burden, particularly on non-Korean firms, as well impose inappropriate CBI disclosure requirements.” The U.S. delegation also notes MOE’s draft K-REACH implementation rules that, among other things, require companies by June 30, 2019, to “pre-report” the substances they manufacture or import, or face being banned from the market. The U.S. delegation “ask[s] you to notify this announcement, take industry comments into consideration, issue the guidance in English, and consider a longer implementation period.”


UK Issues Brexit Whitepaper: On July 12, 2018, the UK government issued a whitepaper entitled “The Future Relationship Between the United Kingdom and the European Union.” The detailed publication includes four main chapters with several contained subchapters, an executive summary, and a section on conclusions and next steps. The whitepaper provides that the UK seeks a “principled Brexit” that respects the results of the referendum and the “decision of the UK public to take back control of the UK’s laws, borders and money.”

The whitepaper provides that Brexit must occur in a manner that supports the UK government’s wider objectives across five key areas of the UK’s national life:

  • For the economy, developing a broad and deep economic relationship with the EU that maximizes future prosperity in line with the modern Industrial Strategy and minimizes disruptions to trade between the UK and the EU.
  • For communities, addressing specific concerns voiced in the referendum by ending free movement and putting in place a new immigration system, introducing new independent policies to support farming and fishing communities, using the Shared Prosperity Fund to spark a new wave of regeneration in the UK’s towns and cities, and keeping citizens safe.
  • For the Union, meeting commitments to Northern Ireland by protecting the peace process and avoiding a hard border, safeguarding the constitutional and economic integrity of the UK, and devolving the appropriate powers to Edinburgh, Cardiff, and Belfast — while ensuring the deal delivers for the Crown Dependencies, Gibraltar, and the other Overseas Territories, noting there will be no change in their long-standing relationships with the UK.
  • For democracy, leaving the EU’s institutions and reclaiming the UK’s sovereignty, ensuring the laws people live by are passed by those they elect and enforced by UK courts, with clear accountability to the people of the UK.
  • For the UK’s place in the world, continuing to promote innovation and new ideas, asserting a fully independent foreign policy, and working alongside the EU to promote and protect shared European values of democracy, openness, and liberty.

The whitepaper provides that the UK government is determined to build, based on these principles, a “new relationship that works for both the UK and the EU.” The UK government believes this new relationship needs to be broader in scope than any other that exists between the EU and a third country. The whitepaper provides that the UK’s new relationship with the EU should reflect the UK’s and the EU’s deep history and close ties, and its unique starting point.

Regarding the post-Brexit economic partnership between the UK and EU, the whitepaper provides that both sides should focus on ensuring “frictionless access at the border to each other’s markets for goods.” Therefore, the UK government proposes establishment of a “free trade area for goods.” The UK government envisions an economic partnership that includes: (1) a common rulebook for goods, including agri-food, covering only those rules necessary to provide for frictionless trade at the border; (2) participation by the UK in those EU agencies that provide authorizations for goods in highly regulated sectors — namely ECHA, the European Aviation Safety Agency, and the European Medicines Agency — “accepting the rules of these agencies and contributing to their costs, under new arrangements that recognise the UK will not be a Member State”; (3) the phased introduction of a new “Facilitated Customs Arrangement” that would remove the need for customs checks and controls between the UK and the EU as if they were a combined customs territory; (4) “new arrangements on services and digital, providing regulatory freedom where it matters most for the UK’s services-based economy”; (5) new economic and regulatory arrangements for financial services, preserving the mutual benefits of integrated markets and protecting financial stability while respecting the right of the UK and the EU to control access to their own markets; (6) continued cooperation on energy and transport; (7) a new framework that respects the UK’s control of its borders and enables the UK and EU citizens to continue to travel to each other’s countries, and businesses and professionals to provide services; and (8) binding provisions that guarantee an open and fair trading environment.

The whitepaper includes several important comments on the post-Brexit UK-EU “security partnership” and “cross-cutting and other cooperation,” and states specifically that the UK seeks post-Brexit access to relevant IT systems and the ability for UK businesses to continue to register chemicals with ECHA directly, “rather than working through an EU-based representative.”

Regarding “a practical Brexit,” the UK government proposes “joint institutional arrangements that provide for proper democratic accountability, allow for the relationship to develop over time, mean cooperation can be managed effectively and enable the UK and the EU to address issues as they arise.” The whitepaper provides that these arrangements, which could take the form of an Association Agreement, would ensure the new settlement is sustainable and works for UK and EU citizens now and in the future. Furthermore, the UK government provides that such arrangements would allow flexibility and ensure that the UK and the EU interpret rules consistently — with rights enforced in the UK by UK courts and in the EU by EU courts, with a commitment that UK courts would pay due regard to EU case law in only those areas where the UK continued to apply a common rulebook.

The UK government “believes this proposal for a principled and practical Brexit is the right one,” and states “the Withdrawal Agreement and the framework for the future relationship are inextricably linked — and so must be concluded together.” To facilitate an orderly transition “from the implementation period into the future relationship,” the UK government emphasizes the need to turn the “Future Framework” into legal text as soon as possible, before ratifying binding agreements to give it effect. The whitepaper states “[the UK government] will now charge the UK’s negotiating team to engage with the EU’s at pace, working to reach a substantive agreement on the Future Framework alongside the Withdrawal Agreement later this year.”