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August 1, 2017

Global Regulatory Update for August 2017

The ACTA Group

Michael S. Wenk, M.S., To Speak At AOCS Latin American Congress And Exhibition On Fats, Oils, And Lipids: Michael S. Wenk, M.S., Senior Regulatory Consultant with The Acta Group (Acta®) and Bergeson & Campbell, P.C. (B&C®), has been invited to speak on the current state of play of Central and South American chemical regulations at the 17th AOCS Latin American Congress and Exhibition on Fats, Oils, and LipidsSeptember 11-14, 2017, in Cancun, Mexico. Mr. Wenk will present “Chemical Substance Management in Central and South America: Insights into Sustainability, Regulatory, and Management Opportunities” at the plenary session on September 11, 2017. The AOCS Latin American Congress is held every other year and attracts representatives from more than 30 countries and over 40 exhibiting companies. The Congress provides an international forum for professionals, scientists, researchers, and students in the fats and oils industry, and enhances their business knowledge of today’s market and how to prepare for the future.


Argentina Updates List Of Domestic Sanitary Products: In 1998, the Argentinian National Drug, Food and Medical Technology Administration (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, or ANMAT), under the auspices of the Ministry of Health and Social Action (Ministerio de Salud y Acción Social), issued Resolution No. 709/98, which established the National Register of Domestic Sanitary Products (Créase el Registro Nacional de Productos Domisanitarios) and which classified said products according to their level of risk. The revised version, ARG/323, was issued on June 20, 2017, for a 30-day comment period, and includes an amended list of categories of products that are either classified or not classified as domestic sanitary products.

As per Article Five of Resolution 709/98, a product’s registration will have a five-year validity. Once this deadline has expired, the products must be re-registered. It should be noted that failing to re-register will result in, without prior notification, the cancellation of registration. Article Six of Resolution 709/98 established two categories of product risks — “Risk I” and “Risk II.” The Risk I category includes “all cleaning and related products in general, except caustics and corrosives that do not require special personal protection for handling,” while the Risk II category “comprises products with antimicrobial activity, with disinfectant activity (insecticides, acaricides, algaecides, etc.), products with a pH value less than two (2) or greater than thirteen (13), products with high oxidizing or reducer [sic] and biological products based on bacteria.”

Annex I of ARG/323 contains the amended list of products classified as domestic sanitary products, therefore requiring registration. Examples of such products are laundry products, descalers and surface-finishing products (all Risk I), and insect repellants formulated with naphthalene, pyrethrins or pyrethroids, sanitizers, and non-caustic and non-corrosive disinfectants (all Risk II).


CONASQ Reviews Comments Submitted On Draft Industrial Chemicals Legislation: The National Commission on Chemical Safety (CONASQ) met at the end of June 2017 and reviewed 801 comments submitted by 236 stakeholders. As reported in Acta’s June 28, 2017, memorandum, “Brazil Inches Forward On Industrial Chemicals Regulation Implementation,” almost two thirds (61 percent) were received from the private sector, followed by civil society (25 percent), government (six percent), academia (five percent), and international (three percent). These comments will be taken into account when revising the draft regulation prior to its submission to the full Congress. CONASQ will publish a detailed review of all 801 comments received, as well as its decision for accepting or rejecting them, and then approving the final text of the draft regulation. Next, the competent authorities — the Ministries of Environment, Health, Labor, and Industry — will review the final draft, incorporate any changes they see fit, and grant their approval. Finally, the final draft will be sent to Congress — estimated presently to be in early 2018 — for consideration and promulgation. More information is available in Acta’s memorandum.


Canada Publishes Year One Updates To Activities Under The Third Phase Of The CMP: On June 17, 2017, Canada published in the Canada Gazette year one updates to the activities under the third phase of the Chemicals Management Plan (CMP). The third phase is a five-year plan that began in April 2016. It includes steps to address the remaining 1,550 priority substances of the original 4,300 substances identified as priorities following categorization of the Domestic Substances List (DSL) under the Canadian Environmental Protection Act, 1999 (CEPA). It also includes the ongoing development of risk management to prevent or control releases of substances that were found to be harmful to human health or the environment. The updates provided in the notice cover the following activities:

  • Planned information-gathering initiatives 2017-2019;
  • Updated two-year rolling risk assessment publication plan for the 1,550 existing substances to be addressed under CEPA (2017-2019);
  • Approach for the identification of risk assessment priorities — results of the 2016 prioritization exercise;
  • Two-year rolling risk assessment publication plan for the remaining existing living organisms to be assessed under CEPA (2017-2019);
  • Publication of prioritization results for the revised In Commerce List with supporting rationale;
  • Updated two-year rolling risk management activities and consultations schedule (2017-2019);
  • Update on CMP health research and monitoring activities;
  • Update on nanomaterials;
  • Updates on activities made under the Food and Drugs Act and the Food and Drug Regulations; and
  • Update on pesticide re-evaluations.

Canada Publishes CMP Progress Report: The summer 2017 issue of the CMP Progress Report covers activities between January and June 2017. It includes the following highlights:

  • Proposed regulations on asbestos expected by the end of 2017: The government expects to publish proposed regulations prohibiting the import, use, sale, and offer for sale of asbestos, as well as the manufacture, use, sale, offer for sale, and import of products containing asbestos, for public comment by the end of 2017.
  • Formaldehyde regulations being developed: To protect the health of Canadians, the government is developing regulations to reduce emissions of formaldehyde from composite wood products. The regulatory development process will include consultations with stakeholders, including provincial and territorial governments, industry, non-governmental organizations (NGO), the public, and other stakeholders. The proposed regulations are expected to be published in the Canada Gazette, Part I, in early 2018.
  • Government phasing out the use of microbeads in toiletries: The government of Canada has published regulations to phase out the use of microbeads in toiletries to protect the long-term health of the environment and to help keep Canada’s lakes and rivers clean. The regulations will phase out the manufacture, import, and sale of microbeads in toiletries used to exfoliate or cleanse. This includes non-prescription drugs and natural health products that contain plastic microbeads. As of January 1, 2018, the manufacture and import of toiletries that contain plastic microbeads will be prohibited, unless the toiletries are also natural health products or non-prescription drugs, in which case prohibition will begin on July 1, 2018. As of July 1, 2018, the sale of toiletries that contain plastic microbeads will be prohibited, unless the toiletries are also natural health products or non-prescription drugs, in which case the prohibition will begin on July 1, 2019.

Canada Publishes Consultation Document On Proposed Approach To Reduce Formaldehyde Emissions From Composite Wood Products: Canada published, on July 31, 2017, a consultation document on the proposed regulatory approach to reduce emissions of formaldehyde from composite wood products. The objective of this consultation document is to inform and solicit comments from stakeholders on the proposed regulatory approach. Stakeholders have the opportunity to provide feedback on the proposal and submit additional information. Submissions are due September 1, 2017. Canada will consider comments and information received related to the consultation document in the development of the proposed regulations, which it expects to publish in the Canada Gazette in 2018.


Ministry Of Environment Asks Producers Of Certain Product Types For Sales And Management InformationIn Acta’s January 4, 2017, “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2017,” we commented how “Virtually every country in Central and South America has either announced plans to develop similar legislation [to manage post-consumer products, most often via ‘take back’ or recycling programs], or has bills which are already under Congressional discussion. Among these are Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Nicaragua, Panama, Peru, and Uruguay.”

The Chilean Ministry of Environment (Ministerio de Medio Ambiente de Chile, or Ministerio) is working toward implementing such a program via its Law for Extended Producer Responsibility and Promotion of Recycling (No. 20.920/2016)” (Establece Marco Para La Gestión De Residuos, La Responsabilidad Extendida Del Productor Y Fomento Al Reciclaje), which was designed to decrease the generation of waste and encourage recycling, re-use, and valuation.

To this end, the Ministerio is requesting producers of the following types of products to provide it with information regarding sales volume and waste management programs, by the due date in parentheses:

  1. Lubricating oils (July 31, 2017);
  2. Electrical and electronic equipment (August 31, 2017);
  3. Cells and batteries (July 31, 2017);
  4. Containers and packaging (August 31, 2017);
  5. Tires (July 31, 2017); and
  6. Newspapers, periodicals, and magazines (July 31, 2017).

As per No. 20.920/2016, producers should report these values through the “Registry of Emissions and Transfers of Contaminants” (Registro de Emisiones y Transferencias de Contaminantes), available at


Collection Regulation For Fees Associated With Registration And Control Of Hazardous Chemicals Proposed: As detailed in our January 4, 2017,Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2017,” the Costa Rican Senate put forth Executive Decree 28112-S (30718 as amended), the “Regulation for the Registration of Hazardous Chemical Products.” The Decree was proposed in two drafts: Draft 1 includes provisions for the registration and control of hazardous substances, while Draft 2 includes language for the implementation of GHS.

In concert with this, the Ministry of Health (Ministerio de Salud) has proposed a Draft Regulation addressing the process by which fees pertaining to the registration, renewal, post-registration changes, and other aspects for hazardous chemicals would be remitted. Payments would be made via the Ministerio de Salud’s “Register It” (Regístrelo) website at The Draft Regulation specifically carves out fee payment exemptions for such products that meet certain criteria, such as finished products, those related to R&D activities in certain cases, those used by “microenterprises,” and others.


Twelve Substances Added To REACH Authorization List: The European Commission (EC) has added 12 Substances of Very High Concern (SVHC) to Annex XIV of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation (i.e., the Authorization List). The substances are:

  • 1-bromopropane (n-propyl bromide);
  • Diisopentylphthalate;
  • 1,2-benzenedicarboxylic acid di-C6-8-branched alkyl esters C7-rich;
  • 1,2-benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters;
  • 1,2-benzenedicarboxylic acid, dipentylester, branched and linear;
  • Bis(2-methoxyethyl) phthalate;
  • Dipentylphthalate;
  • N-pentyl-isopentylphthalate;
  • Anthracene oil;
  • Pitch, coal tar, high temperature;
  • 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated; and
  • 4-nonylphenol, branched and linear, ethoxylated.

The substances have been added to the Authorization List, in accordance with REACH Article 57, due to their toxic for reproduction, carcinogenic, persistent, bioaccumulative, and toxic (PBT), very persistent and very bioaccumulative (vPvB), or endocrine disrupting properties. Member States voted to approve inclusion of the substances in REACH Annex XIV in December 2016. Sunset dates for the substances range from July 4, 2020 – January 4, 2021.

Additional information is available in Commission Regulation (EU) 2017/999.

ECHA Launches EU Observatory For Nanomaterials (EUON): On June 14, 2017, the European Chemicals Agency (ECHA) announced the launch of EUON. ECHA states that EUON “offers a unique web-based information point with factual and neutral content about nanomaterials on the EU market.” EUON is targeted at a wide audience, including consumers, workers, regulators, and scientists. EUON provides information on uses, health and safety issues, research, regulation, and international activities. According to ECHA, EUON will be further developed in the coming years with new content to meet the audiences’ needs. EUON will also carry out studies and make use of external databases and publications. More information is available in ECHA’s June 14, 2017, press release, “EU observatory for nanomaterials launched.”

MSC Agrees Unanimously That BPA Is An EDC: On June 16, 2017, ECHA issued a press release entitled “[Member State Committee (MSC)] unanimously agrees that [Bisphenol A (BPA)] is an endocrine disruptor.” The MSC agreed with the proposal from France for identification of BPA as a SVHC due to its endocrine disrupting properties that cause probable serious effects to human health. The MSC considered that the effects of BPA “give rise to an equivalent level of concern to carcinogenic, mutagenic, toxic to reproduction (CMRs category 1A or 1B) substances.” BPA is already included in the REACH Candidate List of SVHCs due to its toxic for reproduction properties, and ECHA has updated the Candidate List to include the MSC’s determination.

According to French authorities, BPA can cause disruption of the oestrogenic pathway and alter reproductive function, mammary gland development, cognitive function, and metabolism. Germany is expected to submit on August 7, 2017, a proposal for identification of BPA as a SVHC under the REACH Article 57(f) basis that it presents an “equivalent level of concern having probable serious effects to the environment.”

Industry’s response to restrictive measures against BPA has been mixed. PlasticsEurope filed a lawsuit against ECHA for its inclusion of BPA in the Candidate List of SVHCs because the vast majority of BPA uses are as an intermediate, and intermediate uses are exempt “from the entire [REACH Title VII] pursuant to [Article 2(8)(b)], and are thus outside the scope of Articles 57 and 59 and outside the scope of [authorization].” On the contrary, ClientEarth welcomed the restrictions against BPA in its press release entitled “Chemical found in everyday homeware named as ‘dangerous’ after 20 year fight.” ClientEarth stated “[‍i]t is the most widely studied hormone disruptor to date. The vote held this week at [ECHA] is therefore historical … This unanimous agreement is the end of a long battle for scientists who have been working hard to prove that BPA is an [endocrine disrupting chemical (EDC)], and to show the seriousness and breadth of its probable effect on human health and the environment. These include higher risk of cancers, learning disabilities and diabetes.” ClientEarth indicated that it will “back [ECHA]” in potential actions brought against it by BPA manufacturers affected by the MSC’s decision.

ECHA Faces Budget Constraints In 2018: ECHA’s Management Board convened its 46th Meeting on June 21-22, 2017, and ECHA made available its “Update on the Budget 2018 Preparations” (Update). The Update presents the status of ECHA’s request for financial and human resources in the 2018 budget in relation to “the four regulations and new tasks under preparation.” The new tasks being referred to are EDCs, Poison Centers, Occupational Exposure Limits, the EU Chemicals Legislation Finder, and Persistent Organic Pollutants (POP). ECHA indicates in its Update that several discussions have taken place between ECHA and “the relevant Commission services” to establish these additional resource requirements for 2018.

In its Update, ECHA states “[t]he year 2018 is the year for the third REACH registration deadline, which will impact a large number of companies in Europe and the highest number of [Small- and Medium-Sized Enterprises (SME)] to date. The current estimated volume of workload (60,000 dossiers) is significant and ECHA will require additional staff (beyond the ‘core’ REACH/[Classification, Labelling, and Packaging (CLP) Regulation] staff in registration and helpdesk units) to undertake this additional work. To implement effectively the workload related to the final registration deadline and to reduce the impact of the planned redeployment on the rest of ECHA’s [Work Program] 2018, ECHA requested the Commission to refrain from the planned reduction of six Temporary Agent posts in 2018 and postpone this reduction until 2019. ECHA also proposed that the additional staff could be financed by ECHA’s REACH/CLP budget outturn of 2016. These requests were rejected by the Commission, however. As a result, the 2018 deadline work will require internal redeployment to differing degrees, depending on the volume of registrations, and any significant shortfall in fee revenue will also require an additional funding request during 2018 which [the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW)] is willing to put forward.”

Regarding the Biocidal Products Regulation, ECHA stated that its budget request was higher than the Multiannual Financial Framework (MFF) ceiling due to the workload associated with the increase in Union Authorization applications. This request was rejected by the EC, however, the Directorate-General for Health and Food Safety (DG SANTE) has confirmed that additional Competent Authorities could be recruited by ECHA if the revenues from fees are higher than planned in 2018. ECHA’s Update also describes 2018 budget considerations for the Prior Informed Consent (PIC) Regulation, Poison Centers, and the Circular Economy.

REACH Inspectors Find Most Companies Comply With Authorization Requirements: ECHA announced that a pilot project under the Forum for Exchange of Information on Enforcement of 13 SVHCs subject to authorization with sunset dates in 2015 has shown that most of the inspected European companies complied with REACH authorization obligations. According to ECHA, inspectors from 17 participating countries reported a total of 802 inspections within the framework of this project. The vast majority of the companies did not actually use (93 percent) or place on the market (92 percent) any of the substances that had a sunset date in 2015. Inspections showed a non-compliance rate of 10.7 percent and 8.9 percent, respectively. In all cases of non-compliance, inspectors took appropriate enforcement measures, such as verbal or written advice, filing administrative orders, or criminal complaints to remedy the non-compliances. More information is available in ECHA’s June 22, 2017, press release, “REACH inspectors find that not all companies are complying with authorisation requirements.”

EC Announces Revised EU Ecolabel Criteria For Six Widely Used Types Of Detergents: The EC announced on June 23, 2017, that it launched revised EU Ecolabel criteria for six widely used types of detergents: laundry; industrial laundry; dishwasher; industrial dishwasher; hand dishwashing; and hard-surface cleaning detergents. All detergents awarded with the EU Ecolabel will now be free from microplastics. In addition, they will have to meet stricter requirements for plastic packaging. The EC states that once the new criteria come into effect later in June 2017, they will be valid for six years. Companies already holding the EU Ecolabel have 12-18 months to adapt to the new requirements. More information is available in the EC’s press release, “Circular Economy: New EU Ecolabel criteria for six widely used types of detergents to be ‘microplastic free.’

EC Adopts Guidelines To Enhance Business Transparency On Social And Environmental Matters: The EC published on June 26, 2017, non-binding guidelines on the disclosure of environmental and social information. The Directive on disclosure of non-financial and diversity information by certain large undertakings and groups, which entered into force on December 6, 2014, stipulates some minimum requirements on the disclosure of non-financial information by certain large companies, while avoiding any undue administrative burden, in particular for the smallest companies. The frequently asked questions (FAQ) state that the companies concerned will disclose in their annual report relevant information on:

  • Policies, outcomes, and risks, including due diligence that they implement;
  • Relevant non-financial key performance indicators; and
  • Environmental aspects, social and employee matters, respect for human rights, anti-corruption, and bribery issues.

The guidelines are not mandatory and are intended to help companies to comply with the reporting requirements.

Forum Plans Enforcement Projects On Authorization And Registration: On June 27, 2017, ECHA announced that the Forum for Exchange of Information on Enforcement’s seventh major enforcement project, REACH-EN-FORCE-7 (REF-7), will focus on checking duties related to registration and registrations of intermediates. In checking the registration duties, the inspectors will also cooperate with customs authorities to ensure adequate control of imported substances. The Forum will run a third pilot project on authorization in 2019. This project will focus on substances subject to authorization, such as chromates and chromium VI. ECHA states that since many accredited stakeholder organizations expressed interest in the joint action with the Forum on improving the quality of safety data sheets (SDS), the Forum decided to launch such an initiative. The Forum will liaise with the accredited stakeholder organizations in summer 2017 to inform them about how to get involved in this joint action. More information is available in ECHA’s June 27, 2017, press release, “More enforcement on authorisation and registration coming up for 2019.”

BPC Adopts 11 Opinions: ECHA’s Biocidal Products Committee (BPC) adopted at its 21st meeting on June 27-29, 2017, opinions supporting the approval of four active substances for use in disinfectant, preservative, and insecticide biocidal products. The active substances and related product-types are:

  • MBIT for product-type 6:
    • Biocidal products containing MBIT in product-type 6 are used to protect against a wide variety of microorganisms (e.g., fungi) that occur within in-can preservation systems. Examples include paints and detergents. The evaluating Competent Authority of the active substance application is Poland.
  • Imiprothrin for product-type 18:
    • Imiprothrin is an existing active substance for product-type 18. The products containing imiprothrin are ready-to-use insecticidal aerosols designed for use by non-professionals indoors. The evaluating Competent Authority of the active substance application is the United Kingdom (UK).
  • Reaction products of para-formaldehyde and 2-hydroxy-propylamine (ratio 3:2) (RP 3:2) for product-types 2, 6, 11, 12, and 13:
    • Biocidal products containing RP 3:2 are used for disinfection of inner surfaces of vessels and tubes in metal working systems in product-type 2, preservation of fuels prone to bacterial decay in product-type 6, preservation of closed liquid cooling systems in product-type 11, prevention or control of slime growth on materials, equipment, and structures in offshore oil industry installations in product-type 12, and preservation of metal working fluids prone to bacterial decay in product-type 13. The evaluating Competent Authority of the active substance application is Austria.
  • Reaction products of para-formaldehyde and 2-hydroxy-propylamine (ratio 1:1) (RP 1:1) for product-types 2, 6, 11, and 13:
    • Biocidal products containing RP 1:1 are used for the same applications as RP 3:2 in product-types 2, 6, 11, and 13. The evaluating Competent Authority of the active substance application is Austria.

BPC’s conclusion is that these substances in the relevant product-types may be approved. The adopted opinions will serve as a basis for final decision-making by the EC and Member States. Opinions on copper for product-types 2, 5, and 11 are expected to be adopted by written procedure. The adoption of an opinion on cholecalciferol in product-type 14 was delayed because BPC concluded that cholecalciferol is a candidate for substitution. Consequently, a public consultation will need to occur before the opinion is revised and can be adopted.

More information is available in ECHA’s press release and the related Annex.

ECHA Updates Guidance On Substances In Articles: ECHA announced on June 28, 2017, publication of a “comprehensive update” to its guidance on requirements for substances in articles. The update provides more clarity on the communication and notification obligations of companies when SVHCs are contained in articles. The updated guidance includes new examples in line with the September 10, 2015, judgment of the Court of Justice, which further clarified the scope of the obligations. According to the ruling, the legal obligations also apply to articles that are present in complex products, such as a component of a car or a washing machine. The guidance also updates and improves the existing examples, “thanks to experience gained and questions received.” More information is available in ECHA’s June 28, 2017, press release, “Guidance on substances in articles updated.”

ECHA States Actions On Existing Registrations “Show Promising Results”: On June 29, 2017, ECHA announced that since July 2016, it has been carrying out two types of actions to bring existing REACH registrations in line with the legal requirements: reviewing the completeness of existing registrations; and making sure that companies who have registered the same substance are in the same joint submission. According to ECHA, it revoked four registrations: three for being incomplete, and one for breaching the “one substance, one registration” principle. ECHA states that given the positive results of these two campaigns, it is currently building a strategy to verify systematically the completeness of dossiers submitted before the entry into force of the enhanced completeness check. More information is available in ECHA’s June 29, 2017, press release, “ECHA’s actions on existing registrations show promising results.”

ECHA Announces Two Decisions On Appeals Related To Nanomaterials: On June 30, 2017, the ECHA Board of Appeal published two decisions related to nanomaterials. In the July 5, 2017, issue of ECHA Weekly, ECHA states that the Board of Appeal “largely upheld the appeals and annulled most of the requests for information.” In Cases A-014-2015 and A-015-2015, registrants appealed the same 2015 ECHA decision requesting information on synthetic amorphous silica (SAS) following a substance evaluation by the Netherlands Competent Authority. ECHA requested information on the physicochemical properties and uses of different types of SAS and surface-treated SAS. According to ECHA, the Board of Appeal annulled these requests “as it was not clear how the information would be used to clarify the potential concerns which in any case had not been sufficiently demonstrated.” ECHA notes that the Board of Appeal upheld one request in the contested decision — for information on the inhalation toxicity of one type of SAS, following repeat exposure.

EC Announces New Chapter For European Green Products And Organizations: The EC adopted on June 30, 2017, a report presenting the conclusions of the Fitness Check of the Eco-Management and Audit Scheme (EMAS) and of the EU Ecolabel scheme. The EC’s press release describes the EU Ecolabel as a voluntary label intended to promote environmental excellence by serving as a trustworthy reference for consumers. It aims to recognize the top ten to 20 percent of the best performing products. EMAS is a voluntary management scheme for companies and other organizations to improve environmental performance. It spans all economic and service sectors and is applicable worldwide. The Fitness Check assessed whether the EU Ecolabel regulation is fit for purpose, whether its objectives have been met, and whether it has been implemented in a cost-effective way. According to the EC’s press release, the Fitness Check found that implementation of the EU Ecolabel and EMAS must improve for them to reach their full potential as circular economy tools. The EC confirmed its commitment to work with EU Member States for a more focused, effective implementation of both schemes. The report includes follow-up actions to boost the uptake of the schemes. The EC states that it intends to make the EU Ecolabel more focused by bundling closely related product groups when they come up for renewal and to discontinue product groups with limited uptake. The EC wants to increase the added value of EMAS and the benefits delivered to registered organizations and authorities. This includes additional opportunities for EMAS-registered organizations to cut administrative burdens by providing greater regulatory relief, replicating measures used by the EU Member States with a significant number of EMAS registrations, and a better integration of EMAS into the Green Action Plan for SMEs.

Member States Adopt Controversial EDC Identification Criteria: On July 4, 2017, the EC issued a press release entitled “Endocrine disruptors: major step towards protecting citizens and environment.” The EC’s press release states “[t]oday, Member States representatives voted in [favor] of the [EC’s] proposal on scientific criteria to identify [EDCs] in the field of plant protection products. This is an important step towards greater protection of citizens from harmful substances.”

Commissioner for Health and Food Safety Vytenis Andriukatis stated “[t]oday’s vote represents our determination to devise a real EU policy on [EDCs]. After months of discussion we are advancing in the direction of the first regulatory system in the world with legally binding criteria to define what an [EDC] is. This is a great success. Once implemented, the text will ensure that any active substance used in pesticides which is identified as an [EDC] for people or animals can be assessed and withdrawn from the market. We now count on the support of the European Parliament (EP) and the Council, involved in the decision making process, for a smooth adoption and entry into force of the criteria.”

The agreement of Member States on the EDC scientific criteria ends a prolonged disagreement on the appropriate language for the criteria. Twenty-one Member States voted in favor of the proposal. Denmark, Sweden, and the Czech Republic voted against it, while Latvia, Hungary, Poland, and the UK abstained. As noted above, the criteria still requires approval from the Council and the EP before it can be adopted. The agreed upon text excluded a contentious point from previous discussions on the criteria regarding changing the Plant Protection Products (PPP) Regulation from referring to “negligible exposure” to referring to “negligible risk” in relation to exceptions for active substances with endocrine disrupting properties. The EC separated this issue from the criteria proposal, and it is understood that this part of the legal text will be negotiated later this year.

NGOs have criticized heavily approval by Member States of the proposed criteria. ClientEarth issued a press release entitled “Illegal and dangerous endocrine disruptor criteria approved.” In its press release, ClientEarth stated that the accepted criteria threaten human health and the environment, and are illegal because “they overstep the [EC’s] powers.” ClientEarth stated “[t]he criteria — despite changes — still impose a too hard-to-meet burden of proof. They are also unclear, which means there will be more debates [on] what they actually mean and thus more delays in banning these chemicals in pesticides and elsewhere … These EDC criteria were supposed to be grounded in science, and to identify which chemicals are hormone disrupting. Instead, the criteria let industry ‘de-identify’ a chemical as [an] endocrine disruptor, if, for example, it is a pesticide that is meant to be an endocrine disruptor for targeted species.” ClientEarth alleged that the accepted criteria create a “silo approach” by addressing pesticides only, and therefore breach the obligation of the EU to ensure a high level of protection of human health and the environment, and contradict the 7th Environment Action Program.

EDC-Free-Europe also expressed disappointment with the criteria and called on the EP to “reject [the] flawed criteria for the sake of human health and environment protection.” The EDC-Free-Europe coalition identified the following “main concerns” with the accepted criteria for identification of EDCs in the context of pesticides:

  • The criteria require a very high burden of proof, which makes the identification of substances as EDCs very difficult and is likely to result in long delays.
  • The proposed exemption from identification for certain pesticides and biocides that are designed to be endocrine disrupting would strongly undermine the objective of the EU pesticides and biocides law to phase out the use of EDCs.
  • The criteria contradict the EU commitment to horizontal EDC criteria and minimization of EDC exposures as decided in the 7th Environment Action Program.

NGOs Challenge EC Over Lead Chromate Pigment Authorization: ClientEarth, the European Environmental Bureau (EEB), the International Chemical Secretariat (ChemSec), and the International POPs Elimination Network (IPEN) are “taking the [EC] to court after it refused to withdraw an EU-wide permit allowing the use of lead chromate in pigments.” The NGOs indicated in a press release that lead exposure can damage children’s brain development and harm the nervous system while chromium can cause lung tumors in people and animals. The NGOs state “[t]hat is why lead chromate cannot be used in the EU any more unless a company obtains [authorization]. [Authorization] can only be granted if the company shows that the risk is adequately controlled or that no safer alternatives are available. In this case, none of these conditions were met.”

The press release states that ECHA has received 380 notifications of companies declaring the use of lead chromate pigments in the EU since this authorization. The NGOs suggest this is hindering the use of the safer alternatives that EU companies have invested in. Additionally, the NGOs state that many companies have declared their intention to “export these hazardous products to poorly regulated markets outside the EU.”

In October 2016, ClientEarth, EEB, ChemSec, and IPEN requested that the EC reconsider the authorization, however, this request was rejected in May 2017. Sweden took the EC to court over the same authorization, partly because lead chromate pigments have not been used in Sweden for 30 years and “[r]oads and professional vehicles are still painted with sufficiently bright [colors] in this Nordic country.” The NGOs suggest that the authorization “is unacceptable and sets a reckless precedent for the future of the [authorization] process under EU chemicals legislation.”

ECHA Adds PFHxS To The Candidate List, Updates Other Entries: ECHA announced on July 10, 2017, that it added perfluorohexane-1-sulfonic acid and its salts (PFHxS) to the Candidate List and updated entries for BPA and four phthalates to include endocrine-disrupting properties for human health. The substances are:

Substance NameReason for InclusionExamples of Use(s)
PFHxSvPvB (Article 57e)Not yet registered under REACH. May be used as a plasticizer, lubricant, surfactant, wetting agent, corrosion inhibitor and in fire-fighting foams.
4,4’-isopropylidenediphenol (BPA)Endocrine disrupting properties (Article 57(f) — human health)Manufacture of polycarbonate, as a hardener for epoxy resins, as an anti-oxidant for processing polyvinyl chloride (PVC) and in thermal paper production.
Benzyl butyl phthalate (BBP)Endocrine disrupting properties (Article 57(f) — human health)Adhesives, sealants, and coating products.
Bis(2-ethylhexyl) phthalate (DEHP)Endocrine disrupting properties (Article 57(f) — human health)Used as a plasticizer in polymers, such as PVC.
Dibutyl phthalate (DBP)Endocrine disrupting properties (Article 57(f) — human health)Used as a plasticizer in polymers, such as PVC.
Diisobutyl phthalate (DIBP)Endocrine disrupting properties (Article 57(f) — human health)Coating products, fillers, putties, plasters, modeling clay, and polymers

More information is available in ECHA’s July 10, 2017, press release, “One new substance added to the Candidate List, several entries updated.”

EC Creates Knowledge Center To Provide Scientific Evidence On Bioeconomy: On July 20, 2017, the EC announced the creation of the Bioeconomy Knowledge Center to support EU and national policy makers and stakeholders with science-based evidence. According to the EC’s press release, the platform “will not primarily generate knowledge, but will collect, structure and make accessible knowledge from a wide range of scientific disciplines and sources on the bioeconomy, the sustainable production of renewable biological resources and their conversion into valuable products.” According to the EC, the bioeconomyrepresents a significant part of the EU economy, with potential for growth through innovation in agriculture, forestry, bioenergy, and biomass but also in chemicals, materials, waste management, and others. The EC states that the Bioeconomy Knowledge Centre will support it in the review of the 2012 Bioeconomy Strategy, taking into account new political and policy developments, such as the twenty-first session of the Conference of the Parties (COP21) Paris agreement, the United Nations’ Sustainable Development Goals, and the Circular Economy Package.


National Bans To Be Imposed For EDCs: The French Government has stated that it will impose stricter national controls for EDCs, and will legislate national bans against EDCs upon establishment of their hazardous nature. The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) will conduct a risk assessment of the most widely used products containing EDCs. These developments follow France’s support of the scientific criteria for identification of EDCs in the context of pesticides, which was recently approved by Member States and awaits approval from the Council and EP. France had since long opposed the criteria, but voted in favor of it, giving the EC the required qualified majority.

In a press release from the French Ministry of Ecology, it stated that in return for its vote, France was able to obtain commitment from the EC on a number of actions against EDCs, including an EU-wide strategy for toys, cosmetics, and food packaging; the immediate implementation of the new criteria to substances currently being re-assessed; and an additional 50 million Euros for EDC research.

Additional information is available, in French, in the Ministry’s press release.


IARC Will Convene Advisory Group In 2018/2019 To Consider Nominations: To assist IARC in selecting agents for review in future Monographs, IARC regularly convenes international, interdisciplinary Advisory Groups to review all public nominations and to recommend those it considers to be of high priority. According to information on its website, IARC will convene its next Advisory Group in 2018/2019. IARC encourages the general public, the scientific community, national health agencies, and other organizations to nominate agents for review in future IARC Monographs. IARC states that nominations may include chemicals, mixtures, occupations, physical agents, biological agents, lifestyle factors, and anything else suspected of causing cancer in humans. IARC will select agents for review based on: (a) evidence of human exposure; and (b) evidence or suspicion of carcinogenicity. IARC notes that in response to new scientific information or an urgent public health need, it may schedule nominated agents for review at any time.


Committee Formed To Prepare National Action Plan For Chemicals Under World Bank Project: In April 2017, the Ministry of Environment, Forest, and Climate Change formed the National Coordination Committee to prepare a National Action Plan for Chemicals under the World Bank-aided Capacity Building for Industrial Pollution Management Project being implemented by the Ministry. The Committee Chair is the former Secretary of the Ministry. Other members include the former head of the Environment Policy Division, Confederation of Indian Industry; the former Additional Director of the Center Pollution Control Board and current advisor to the Center for Science and Environment; and the current Director of the Department of Chemicals and Petrochemicals, Ministry of Chemicals and Fertilizers. An action plan for chemicals that are produced, imported, and consumed in India may include:

  • A policy framework, particularly where registration of chemicals is needed;
  • Phasing out of chemicals to be proposed over a short- and long-term period based on safety to human health and the environment;
  • The need for development of infrastructure to analyze chemicals and their derivatives and effects on users;
  • Revisions to existing legislation; and
  • India’s involvement in international programs and agreements.

The project is due to be completed by September 15, 2017, or as extended.


Mexico Issues NOM Regarding Health And Safety Procedures Relating To Workplace Chemicals: On June 22, 2017, the Mexican Ministry of Labor and Social Welfare (Ministerio de Trabajo y Previsión Social, or Ministerio) published the Draft Mexican Official Standard (Norma Oficial Mexicana or NOM) PROY-NOM-005-STPS-2017, “Handling Hazardous Chemicals or Mixtures In Their Workplaces — Conditions And Procedures Of Safety And Health” in the Official Journal (Diario Oficial de la Federacíon). As per the Preface, the intent of the draft NOM is to “establish safety conditions and procedures to prevent risks to workers’ health and avoid damage to the workplace, the handling of hazardous chemicals or their mixtures.”

If signed into national law, PROY-NOM-005-STPS-2017, which is currently undergoing a 60-day notice and comment period, would repeal NOM-005-STPS-1998. Similar to the Federal Register notice and comment process in the U.S., at the conclusion of the 60-day period, the Ministerio will publish their responses to the comments, accepting or rejecting each one. Those accepted will become part of PROY-NOM-005-STPS-2017.

Some key items of note in the draft PROY-NOM-005-STPS-2017 are as follows:

  • While proposed to be national in scope, the draft NOM makes a distinction in the requirements to be followed. Workplaces “dedicated to the commercialization of dangerous chemicals in their original packaging and containers [where] there is no transfer of them” would be subject to a specific set of requirements in the draft NOM. “If they handle dangerous chemical substances in containers or packages whose contents do not exceed five kilograms or five liters, they must comply with the safety or precautionary measures established in [a second set of requirements in the draft NOM].”
  • The draft NOM adds several risk analysis chapters. Among these are those that pertain to security procedures, emergency care plans, training, and verification units. Further, it calls for a risk analysis, which is “in line with what is established in other regulations, in addition to allowing the use of any other methodology that has [been] implemented [in] the work center, in order to identify, evaluate and generate alternatives [t]o control the significant hazards associated with hazardous chemicals or mixtures handled in the workplace.”
  • The draft NOM details the requirements to form an “emergency care plan” (which readers may know as an Emergency Response Plan, or ERP) related to the handling of chemical substances, and aspects related to the training that must be provided to occupationally exposed personnel.”
  • The draft NOM introduces the idea of “Control Banding”, which is “a technique used in the evaluation and management of occupational hazards, and [which] proposes control measures to protect workers when handling hazardous chemicals [o]r their mixtures.”


Long Awaited Compliance Management Catalogue (First Batch Draft) And List Of Exemptions Under China’s RoHS2 Regulation Released: On July 1, 2016, in China, the Administrative Measures for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products (China RoHS2) became effective. It requires China’s Ministry of Industry and Information Technology (MIIT) to develop a compliance management catalogue and its exemptions for its implementation.

On June 29, 2017, MIIT released the Compliance Management Catalogue of Electrical and Electronic Products for the Restriction of the Use of Hazardous Substances (first batch) draft for public comment and the List of Exemptions for the Restriction of the Use of Hazardous Substances to the Compliance Management Catalogue under China RoHS2. The comment period ended on July 28, 2017. An implementation date was not provided.

The Compliance Management Catalogue includes refrigerators, air conditioners and filters, washing machines, electric water heaters, printers, copy machines, fax machines, television sets, monitors, personal computers, handsets for wireless communication, and telephones, totaling 12 types of products. The List of Exemptions include mercury (Hg) in certain lamps, lead in certain glasses, alloys, or lamps, cadmium (Cd) in certain electronic products, and hexavalent chromium (Cr(IV)) as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators.


Turkey Publishes Significantly Delayed REACH-like Law: On June 23, 2017, Turkey’s Ministry of Environment and Urbanization (MoEU) published its REACH-like KKDIK Regulation. As reported in Acta’s memorandum entitled “Turkey Catching Up with the [EU’s REACH] Regulation,” the name “KKDIK” is derived from the first letters of “Registration,” “Evaluation,” “Authorization,” and “Restriction” in Turkish. Similar to EU REACH, KKDIK requires companies to register substances manufactured in Turkey or imported into Turkey in quantities of greater than one metric ton per annum within prescribed deadlines.

Following a delay of more than 18 months, KKDIK will enter into force on December 23, 2017, and will replace the following regulations: (1) Regulation on the Inventory and Control of Chemicals; (2) Regulation on the Preparation and Distribution of SDSs for Hazardous Materials and Products; and (3) Regulation on the Restrictions Relating to the Production, Supply to the Market, and Use of Certain Hazardous Materials, Products, and Goods.

KKDIK sets a pre-registration deadline of December 31, 2020, and a registration deadline of December 31, 2023. KKDIK tonnage bands, data requirements, and rules related to polymers, intermediates, and joint submission are similar to EU REACH. Authorization and Restriction processes and rules under KKDIK are also similar to EU REACH (e.g., SVHC Candidate List, Authorization List, Restricted Substance List). Companies based outside Turkey that are subject to regulatory obligations are required to appoint Only Representatives in Turkey to address compliance with KKDIK. Importantly, SDSs for Turkey must be authored in Turkish and comply with relevant standards.

More information is available in KKDIK, in Turkish.


NAVS Identifies Brexit-related Concerns For Animal Testing: On July 12, 2017, the National Anti-Vivisection Society (NAVS), “the world’s first body to challenge the use of animals in research,” issued a press release entitled “Brexit concerns for lab animals.” The press release states “[t]here are particular concerns that Brexit could harm the development of alternative methods and lead to an increase in duplication of animal experiments if not addressed. Also that some areas covered by EU but not UK law could be dropped: controls on inspections, detailed recording on cat, dog and primate use, and a commitment to phase out the use of macaques from wild caught parents.” NAVS described the reduction in animal testing that has occurred in the UK due to EU regulations and stated that it “is seeking a clear commitment” from the UK government that such measures will not be “dismantled.”

NAVS’ press release indicates that while the UK is unlikely to allow cosmetics testing on animals “once again,” the EU Cosmetics Directive also bans the import of products that have been tested on animals. In its press release, NAVS analyzed Home Office figures on animal testing, which indicate that “3,867,528 animals were used for research last year, a decrease of 201,821.” Within tests conducted on these animals, 784,824 experiments and breeding procedures “forced animals to suffer [severely or moderately].” The animals used for testing included mice, fish, dogs, and monkeys.

NAVS stated “[s]ecrecy is also an issue,” indicating that the wider public and scientific scrutiny of Home Office decisions is prevented by Section 24 of the Animals (Scientific Procedures) Act which places a “blanket ban” on the release of details of animal experiments. NAVS stated that proposals to reform Section 24 were announced over three years ago, “but action has yet to be taken, or the results of the consultation published.”


Draft Of New Chemicals Law Sent To WTO: Vietnam hasgiven the global chemical industry insight into its proposed chemical substance regulation as part of the document’s submission to the World Trade Organization (WTO). If enacted into national law, it would replace the current 2007 Chemical Law as implemented via Decree 108/2008/ND-CP.

The draft law reaffirms the country’s commitment to the enactment of a national chemical inventory process. It specifically addresses chemical safety, via the issuance of an updated list of restricted or registration-requiring chemicals, as well as adding new reporting requirements for same. Additionally, the draft law contains five appendices that list approximately 1,300 chemical substances, replete with chemical names and Chemical Abstracts Service (CAS) Numbers, broken down into five categories: (1) chemical substances subject to conditional, or regulated, production; (2) chemical substances subject to business restrictions (e.g., locations of sale); (3) chemical substances banned from use in Vietnam; (4) chemical substances requiring prevention plans and response measures; and (5) chemical substances that must be notified to the national authority before manufacture or import.