Global Regulatory Update for December 2016


The Acta Group extends its best wishes to our clients and many friends and we wish you and your family a happy, healthy, and peaceful New Year. As we have for many years, the firm has made a contribution to the House of Ruth, a shelter for battered women and their children, in lieu of gifts to our clients, and on our clients’ behalf.

ARGENTINA

Argentina Establishes “Take Back” Regulation For Pesticide Containers: On October 11, 2016, the Argentine Senate and Chamber of Deputies (the lower house of the Argentine National Congress) issued Law No. 27279 (Law), the “Integral Management System of Empty Containers of Phytosanitary Products,” which addresses the “management of empty packaging of plant protection products” -- primarily pesticides. Those subject to the Law are “any natural or legal person, public or private, that applies or releases to the environment phytosanitary products” (Article Four).

As laid out in Article Three, the objectives of the Law are four-fold:

  • Ensure that a comprehensive management program for the management of such empty containers is carried out in a way that protects both the population and the environment;
  • Improve the effectiveness of the program as a whole, recognizing that there are various types of such programs already in place;
  • Streamline the administrative process for registration and authorization of pesticide products, as it presently exists; and
  • Establish and define the different stages included in the management of such containers.

Article Six of the Law speaks to the hierarchy of options under which the empty packaging products should be addressed; firstly, preventing the generation of such containers (that is, reducing the amount of pesticides produced at the source). The second option is reuse, followed by recycling of the container, “valorization” by the Argentinian authority, and finally disposal. It is important to note that the “reuse” option may only occur where the regulation specifically allows for such.

Other key elements of the Law include:

  • Article 11, Subsection B, determines the specific procedures to be employed to encourage the end-user of the product to return the empty container for management. Interestingly, this section directly provisions for a ban on future sales to an end user who fails to return the containers for proper disposal.
  • Article 11, Subsection E, sets out a requirement for “traceability and control” of the empty containers, as a means of verification;
  • Article 13 defines the three stages of empty container management, specifically:
    • The user and/or applicator of the product must bring the container to a Transitory Storage Center (Centro de Almacenamiento Transitorio, or CAT);
    • Containers received in the CATs will be managed by an “operator,” who will “modify the physical characteristics and/or chemical composition…in such a way to eliminate their harmful properties, to recover energy and/or resources, or [ensure] a less toxic residue is obtained… .” Actions at the CATs will be the responsibility of the registrant, and the “traceability and control” aspect mentioned earlier will be applied here, via recordkeeping; and
    • Thirdly, the CAT operator will send the modified material and the containers for subsequent reintegration into the production process.

Article 19 of the Law details the specific responsibilities of the pesticide product registrant:

  • Identify and label the packaging to ensure correct information;
  • Establish, in the distribution and sale channels, information mechanisms that facilitate the comprehensive management of empty containers;
  • Consider environmental aspects to minimize the generation of waste; and
  • Institute training and awareness programs with respect to proper management of empty containers.

Finally, Article 25 sets out the potential sanctions under the Law:

  • A warning;
  • A fine of 300 to 10,000 sueldos básicos (“basic salaries”);
  • Suspension of activities of from 30 days to one year, depending on the circumstances; and
  • Temporary or permanent closure, in whole or in part.

Note that the sanctions are not exclusive, and may be applied concurrently in certain cases.

The Law enters into force 90 days after its publication in the Argentinian Official Gazette, the Boletín Oficial de la República Argentina, and registrants will have 270 calendar days from that date to bring their pesticide container management systems in line with the Law. After that period, marketing of such products where the empty containers are not managed in accordance with the regulation will be prohibited.

AUSTRALIA

Australia Begins Public Consultation On Draft National Standard For The Environmental Risk Management Of Industrial Chemicals: On November 24, 2016, the Australian Department of the Environment and Energy began a public consultation on the Draft National Standard for the Environmental Risk Management of Industrial Chemicals and a supporting Draft Explanatory Document. According to the Department, the primary purpose of the papers is to outline the design and operation of the National Standard. The Draft National Standard contains risk management measures applicable for each Environment Schedule under the Standard. The Draft Explanatory Document provides supporting information for the scheduling criteria and risk management measures and outlines the processes that will support decision-making under the Standard. The National Standard will apply to all industrial chemicals, and is intended to fill a gap identified for the environmental management of industrial chemicals. Therefore, the Draft National Standard does not explicitly manage risks to human health. The National Standard includes three general categories for industrial chemicals -- high, intermediate, and low concern -- that span seven Environment Schedules:

  • Environment Schedules 1 and 2 -- Low Concern;
  • Environment Schedule 3 to 5 -- Intermediate Concern; and
  • Environment Schedules 6 and 7 -- High Concern.

Each of the seven Environment Schedules has a set of outcome-based risk management measures. The risk management measures target risks to the environment from the intended use of industrial chemicals and may cover the entire lifecycle of the chemical. The risk management measures focus on protecting the environment from the releases of industrial chemicals that may occur during the intended use and processes associated with the intended use of the chemical. Comments on the Draft National Standard are due March 3, 2017.

CANADA

Canadian Parliamentary Committee Seeks Input In CEPA Review: On October 24, 2016, the House of Commons Standing Committee on Environment and Sustainable Development announced that it is engaged in a comprehensive review of the provisions and operation of the Canadian Environmental Protection Act, 1999 (CEPA). The Committee states that any interested group or individual is welcome to submit a written brief for the Committee’s consideration. Based on testimony received to date, the Committee has identified the following non-exhaustive list of themes that stakeholders may wish to address in their written briefs:

  • The Chemicals Management Plan -- Assessment (hazard- vs. risk-based approach, consideration of alternatives, setting persistence and bioaccumulation triggers);
  • Risk management, including pollution prevention planning and virtual elimination;
  • Integrating environmental justice into assessments and management of substances, and public participation in CEPA;
  • The respective roles of CEPA and other federal acts and programs for managing substances, pesticides, food, and drugs;
  • Monitoring;
  • The National Pollutant Release Inventory;
  • Air quality and drinking water standards;
  • Animate products of biotechnology;
  • Government operations on federal and aboriginal land; and
  • Enforcement.

Briefs were due December 1, 2016. Briefs submitted after the deadline will be considered only if time permits.

Canada Planning For DSL Inventory Update: According to Environment and Climate Change Canada, the upcoming Domestic Substances List (DSL) Inventory update will be published in early 2017 under CEPA Section 71. The list of substances proposed to be included consists of approximately 1,500 substances. The forthcoming Section 71 notice will seek to obtain updated information on the commercial status of listed substances that are remaining priorities and to support any subsequent risk assessment and risk management activities, if applicable.

EUROPEAN UNION (EU)

Fifteenth Round Of TTIP Negotiations Concluded: The 15th Round of Negotiations for the Transatlantic Trade and Investment Partnership (TTIP) took place in New York on October 3-7, 2016. A “major part of the Round was dedicated to discussions on the EU text proposal for a Chemicals Sector Annex” and the EU clarified its stance that “the question of whether this would become an Annex to the Regulatory Cooperation Chapter or a stand-alone Chapter remained open for a final decision to be taken later.” The U.S. raised several questions on the EU’s proposal, largely for clarification, and indicated that it was still working on its own proposal.

At the meeting, the EU and U.S. reviewed progress with pilot projects on priority chemicals and classification and labelling of substances. The U.S. “informed that some pending information related to one of the pilot projects on the assessment of priority substances would be published soon.” Additionally, the technical analysis concerning difficulties in classification rules for mixtures in Safety Data Sheets (SDS) was completed and it was agreed to start a broad consultation with Member States and stakeholders to gather feedback on whether the identified differences lead to problems in practice.

The U.S. and EU reviewed briefly the possible objectives for cooperation on pesticides and the EU “called on the [U.S.] to soon present its legal draft” and indicated that “[o]nly then it will be possible to gauge the ambition, feasibility and value-added for regulatory cooperation in this area.” The “EU Proposal for an Annex on Cosmetics” and the related U.S. text were discussed at the meeting. The EU “reiterated that in its view the scope of the TTIP provisions on cosmetics should be as comprehensive as possible in order to cover all products falling under the legal definition of cosmetics in the EU” as some cosmetics in the EU are classified as over-the-counter drugs in the U.S.

TTIP discussions will continue between the EU and U.S. in the 16th Round of Negotiations, which is expected to take place in early 2017.

ECHA, Cefic, And DUCC Collaborate To Promote Sector Use Maps: On October 6, 2016, the European Chemicals Agency (ECHA) issued a press release entitled “Communication is Key to Chemical Safety: ECHA, [the European Chemical Industry Council (Cefic) and the Downstream Users of Chemicals Co-ordination Group (DUCC)] Join Forces.”

ECHA’s press release states: “The EU chemical industry, together with ECHA, has today taken an important step towards enhancing communication around chemical safety by making a joint statement. It covers the combined efforts of [ECHA, Cefic, and DUCC] to improve communications along the supply chain for the use of chemical products in Europe.”

The joint statement was signed by Marco Mensink, Director General at Cefic; Janice Robinson, Chair at DUCC; and Geert Dancet, Executive Director at ECHA on October 6, 2016. The joint statement indicates that clear and accurate information on the conditions of safe use of chemicals generated and communicated along the supply chain is “essential in ensuring the successful implementation of the [EU’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation]” and acknowledges “the crucial role that sector use maps play in achieving excellence in supply chain communication.”

In the joint statement: (1) Cefic commits to raising awareness and encouraging its member companies to utilize sector use map information for their 2018 registrations and when updating previous registrations; (2) DUCC commits to continuing to raise awareness among downstream industry organizations to produce sector use maps to support registrants in generating meaningful exposure scenarios; and (3) ECHA commits to support industry in ensuring that the communication on safe use up and down the supply chain is comprehensive, effective, and easy to understand.

More information is available in ECHA’s press release, “First sector use maps published.”

MEPs’ Vote To Ban BPA In FCMs Receives Mixed Response From Industry: On October 6, 2016, a large majority of Members of the European Parliament (MEP) supported the Committee on the Environment, Public Health and Food Safety’s (ENVI) Report and introduced the related Amendment, which “[calls for a ban on Bisphenol A (BPA) in all Food Contact Materials (FCM)].” The report encourages the “[European Commission (EC)] to ensure better coordination and a more coherent approach between the REACH and FCM legislation, in particular as regards substances classified as [carcinogenic, mutagenic, or toxic for reproduction (CMR) (Categories 1A, 1B and 2) or Substances of Very High Concern (SVHC)] under REACH.”

The Report and Amendment “[welcome] the fact that, following the recent [European Food Safety Authority (EFSA)] opinion, the [EC] has finally announced its plan to introduce a migration limit of 0.05 mg/kg for BPA for packaging containers made of plastic, as well as for varnishes and coatings used in metal containers.” The Report originally stated that this migration limit is “an improvement compared to the current migration limit of 0.6 mg/kg.”

The MEPs’ Amendment modified the language in Paragraph 32 of the Report to urge a ban on BPA in all FCMs because multiple EFSA re-evaluations over the last decade have not addressed effectively all health concerns and EFSA will “again re-evaluate the hazards of BPA in 2017,” following publication of a report that raises concerns that the current tolerable daily intake (TDI) does not protect [fetuses] or infants from the effects of BPA on the immune system and recommends advising consumers to reduce their exposure to BPA from food and other sources.

The MEPs’ vote, which does not compel the EC to change the law for BPA in FCMs, has been welcomed by CHEM Trust, however, the Association of Plastics Manufacturers (Plastics Europe) and other groups have criticized the MEPs’ opinion and efforts.

ECHA’s BPC Supports Three Approvals, Including A Nanomaterial, And One Non-Approval: At its October 11-12, 2016, meeting, ECHA’s Biocidal Products Committee (BPC) supported three approvals and one non-approval of active substance and product-type combinations.

The BPC supported the approval of:

  • Dichlofluanid for product-type 21;
  • Silicon dioxide Kieselgurh for product-type 18; and
  • Pyrogenic, synthetic amorphous silicon dioxide, nano, for product-type 18.

The approval of pyrogenic, synthetic amorphous silicon dioxide, nano marks BPC’s first approval of a nanomaterial. The BPC adopted an opinion of non-approval for polyhexamethylene biguanide for product-type 5 as the environmental risks could not be appropriately mitigated.

The BPC’s adopted opinions will serve as a basis for final decision-making by the EC and EU Member States. More information is available in ECHA’s press release, “[BPC] adopts four opinions on active substances.”

Implementing Regulation 2016/1802, R4BP 3, And SPC Editor Offer Greater Flexibility For Authorization Of Biocidal Products: Commission Implementing Regulation (EU) 2016/1802 was published in the Official Journal of the EU on October 12, 2016, and entered into force on November 1, 2016. The Implementing Regulation amends Commission Implementing Regulation (EU) 414/2014 on the Authorization of Same Biocidal Products to add new possibilities requested by industry.

Following the updates made by Implementing Regulation 2016/1802, companies can use the secondary authorization processes for products based on existing or ongoing authorization applications for identical products for:

  • A product when it is part of a product family for which an authorization (or authorization application) exists;
  • A product family when it is part of a larger product family for which an authorization (or authorization application) exists; and
  • National Authorization when a corresponding Union Authorization (or authorization application) exists.

To allow for the new possibilities under Implementing Regulation 2016/1802, ECHA has launched updated versions of the biocides IT tools, the Register for Biocidal Products (R4BP 3), and the Summary of Product Characteristics (SPC) Editor. R4BP3 has been updated to support the new authorization scenarios and the SPC Editor has a new interface that supports the creation of product families with three levels: (1) product family; (2) sub-family (meta-SPC); and (3) product level. The existing summaries of product characteristics in R4BP 3 will be migrated to the new three-level format automatically.

More information is available in ECHA’s press releases, “More flexibility for [authorization] of biocidal products” and “New features in biocides IT tools.”

ECHA Board Of Appeal Annuls Four Decisions Requesting Substance Identity Information On A Nano Structured Substance: In cases A-008-2015, A-009-2015, A-010-2015, and A-011-2015, the ECHA Board of Appeal examined appeals against compliance check decisions made by ECHA requesting further substance identity information from four registrants of a “nano structured” substance. As reported in Bergeson & Campbell, P.C.’s (B&C®) July 29, 2015, blog item, “Companies Appeal ECHA’s Requests for Information Concerning Nanoforms,” ECHA adopted the contested decisions on December 17, 2014, following a compliance check under the dossier evaluation procedure of the submitted registration. In each contested decision, ECHA found that the registration did not comply with the requirements of Article 10(a)(ii), as well as Annex VI, Section 2 of REACH. ECHA requested that each appellant submit the following information:

  • Name, molecular, and structural formula, or other identifier of the substance (Annex VI, 2.1 and 2.2);
  • Composition of the substance (Annex VI, 2.3); and
  • Description of the analytical methods used (Annex VI, 2.3.7).

ECHA announced in its October 12, 2016, ECHA Weekly that the Board of Appeal found that the contested decisions “breached the principle of legal certainty as some of the terms used, specifically ‘grades’, ‘forms’ and ‘nanoforms’, were not clearly defined and did not allow the Appellants to clearly ascertain what information they were required to provide in order to comply with the Agency decisions.” The Board of Appeal annulled the contested decisions. The appellants raised other pleas (e.g., whether ECHA could legally require them to submit further information to allow for a more detailed identification of the nanoforms of the registered substance). The Board of Appeal concluded that since it is not clear from the contested decisions what information the appellants are required to provide, it was not possible to decide on the legality of those requests.

Company Announces First REACH Registration Of Single Wall Carbon Nanotubes: On October 13, 2016, OCSiAl announced that it is the first manufacturer of single wall carbon nanotubes (SWCNT) to complete REACH registration. According to OCSiAl, the registration was successfully completed thanks to the collaboration between OCSiAl’s Health and Safety Department, Envigo, and Intertek, which jointly completed the work involved in demonstrating compliance with the standards and requirements of REACH. Envigo’s press release states that scientists at OCSiAl, Envigo, and Intertek collaborated to research and test the potentially hazardous properties of SWCNTs. These efforts resulted in a technical and highly detailed analysis of SWCNTs and their nature and potential risks, as well as specifications for particular methods of risk management

Member States Grant Authorizations For TCE: At an October 26, 2016, REACH Committee meeting, Member States discussed authorization applications for uses of Trichloroethylene (TCE), a known carcinogen listed in REACH Annex XIV. Use of TCE in the EU has been prohibited since April 2015, except for companies granted authorization to use the substance or companies that have submitted applications for authorization.

A majority of Member States agreed to approve Parker Hannifin Manufacturing Netherlands’ (Parker Hannifin) authorization application for use of TCE as a process solvent for the manufacturing of modules containing hollow fiber glass separation membranes. Parker Hannifin requested a review period of 18 years for its use of TCE, however, the Socio-Economic Analysis Committee (SEAC) opined that a review period of 12 years is suitable. The SEAC stated that “although the applicant [provided] arguments for [an 18-year review period], he would have to show that there is an exceptional case for justifying a longer than [12-year] review period. In SEAC’s opinion, producing for the aviation industry, as presented in the application, under certain requirements imposed by authorities (airworthiness certificate) does not constitute an exceptional case.”

Domo Caproleuna GmbH’s (Domo Caproleuna) application for authorization in accordance with REACH Article 62 for the industrial use of TCE as an extraction solvent for the purification of caprolactam from caprolactam oil was granted with a review period of seven years from the sunset date in REACH Annex XIV. Under the authorization granted to Domo Caproleuna, it must “conduct regular occupational exposure measurements” that must: (1) take place at least annually; (2) be based on relevant standard methodologies or protocols; (3) comprise personal inhalation exposure and biomonitoring; and (4) be representative of the range of tasks with possible exposure to TCE, and of the total number of workers that are potentially exposed, including process, maintenance, and laboratory workers.

The REACH Committee decided that further discussion is needed on Chimcomplex S.A. Borzesti’s authorization application for TCE.

ECHA Publishes Proposed CoRAP Update: On October 27, 2016, ECHA announced the proposed Community Rolling Action Plan (CoRAP) update. According to ECHA, 24 substances are expected to be evaluated in 2017, 47 in 2018, and 46 in 2019. ECHA prepared the draft plan together with the EU Member States, taking into account risk-based criteria to select the substances. ECHA states that the final plan will be adopted in March 2017. ECHA encourages registrants of listed substances to begin coordinating their actions and to contact the evaluating Member States. In particular, according to ECHA, it is important that use and exposure scenarios, as well as the exposure estimations, are up-to-date and clearly documented within the chemical safety reports of the registrants. For the 24 substances subject to evaluation in 2017, dossier updates, where relevant, should be made before March 2017. ECHA’s Member State Committee will prepare an opinion on the proposed update in February 2017. Based on the opinion, ECHA will adopt the final CoRAP update for 2017-2019 and publish it in March 2017. From the publication, Member States will have one year to evaluate the substances specified for 2017. Where necessary, they will prepare a draft decision to request further information to clarify the concerns. ECHA notes that the number of substances to be evaluated in 2017 is lower than in previous plans. According to ECHA, evaluations of 32 substances have been postponed to 2018 and 2019 because of pending compliance checks on those substances. To avoid overlaps, ECHA states that it needs to conclude compliance checks on the majority of substances before their evaluation can start. More information is available in ECHA’s October 27, 2016, press release, “Member States plan to evaluate 117 substances in 2017-2019.”

EC Begins Public Consultation In Relation To REACH REFIT Evaluation: On October 28, 2016, the EC began a public consultation in relation to the REACH Regulatory Fitness and Performance Program (REFIT) evaluation. The objective of the consultation is to obtain stakeholder views on the general approach to the 2017 REACH REFIT evaluation and to collect stakeholder views on the strengths and weaknesses of REACH, as well as any potentially missing elements. The responses will be taken into consideration in the preparation of the EC Staff Working Document, presenting the results of the REACH REFIT evaluation and the EC general report on the functioning of REACH addressed to the European Parliament (EP), the Council of the EU, the European Economic and Social Committee, and the Committee of the Regions. The consultation is part of a broader stakeholder consultation strategy that also includes a Small- and Medium-Sized Enterprises (SME) panel circulated through the Europe Enterprise Network. The consultation questionnaire is available in English, German, and French. Responses are due January 28, 2017.

REF-6 To Focus On Classification And Labelling Of Mixtures And SDSs: On November 8-10, 2016, ECHA’s Forum for Exchange of Information on Enforcement decided at its 25th meeting that the subject of its sixth major coordinated enforcement project, REACH-EN-FORCE-6 (REF-6), will be “classification and labelling of mixtures including the check of relevant parts of the SDS.”

REF-6 will also have optional modules that will allow national enforcement authorities “to check a number of other [Classification, Labelling, and Packaging (CLP) Regulation] obligations.” These include obligations related to notifying classification to the C&L Inventory, the duty to apply harmonized classification and labelling, and new rules for packaging of liquid laundry detergent caps.

The scope of REF-6 was developed based on proposals from Member States, accredited stakeholder organizations, the EC, and ECHA. REF-6 will be prepared in 2017 and inspections will take place in 2018. Publication of the report on REF-6 is expected “near the end of 2019.” Further information is available in ECHA’s press release, “Forum launches major project on classification and labelling of mixtures.”

ECHA Proposes Nine SVHCs For Authorization: ECHA announced on November 10, 2016, that it recommended nine SVHCs be added to the Authorization List. According to ECHA, the SVHCs were prioritized from the Candidate List because of their high volume and widespread uses, which may pose a threat to human health, or may be used to replace other substances already on the Authorization List. The SVHCs and examples of their uses in the scope of authorization include:

Substance name (and SVHC property)

Examples of uses in the scope of authorization

1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear
(toxic for reproduction)

Plasticizer.

Dihexyl phthalate
(toxic for reproduction)

Plasticizer.

Trixylyl phosphate
(toxic for reproduction)

Lubricants, greases, hydraulic fluids, metal working fluids, plastic products.

Sodium perborate; perboric acid, sodium salt
(toxic for reproduction)

Detergents and bleaching products.

Sodium peroxometaborate
(toxic for reproduction)

Detergents and bleaching products.

Pentalead tetraoxide sulphate
(toxic for reproduction)

Production of batteries.

Tetralead trioxide sulphate
(toxic for reproduction)

Production of batteries. Coatings and inks for mirror backing.

Orange lead (lead tetroxide)
(toxic for reproduction)

Production of batteries. Adsorbents, paints, lubricants, corrosion inhibitors, explosives, rubber products.

Lead monoxide (lead oxide)
(toxic for reproduction)

Production of batteries. Adsorbents, catalysts, lubricants, corrosion inhibitors, rubber products. Surface treatment (plating).

The final decision on the inclusion of the substances in the Authorization List and on the dates by which companies will need to apply for authorization to ECHA will be taken by the EC in collaboration with the EU Member States and the EP. More information is available in ECHA’s November 10, 2016, press release, “ECHA proposes nine substances for authorisation.”

Member States Support Lower Limit For BPA In Toys: On November 14, 2016, EU Member State officials voted at a meeting of the EU Safety of Toys Committee to lower the migration limit for BPA in toys for children under three years old from 0.1 mg/l to 0.04 mg/l. The revised limit is addressed in a proposed Commission Directive, which will amend Appendix C of Annex II to the Toy Safety Directive.

The proposed Directive states: “In the light of available scientific evidence and considering the differences between toys and materials which come into contact with food, the currently applicable specific limit value for [BPA] in toys is too high and should be revised … While it may be necessary to review the migration limit if relevant new scientific information becomes available in the future, the limit reflecting current scientific knowledge should be laid down in order to ensure adequate protection of children.”

The revised limit for BPA in toys will enter into force 18 months after the amending Directive is published in the Official Journal of the EU.

ECHA Announces Last Call To Pre-Register Low Volume Chemicals: On November 16, 2016, ECHA issued a press release reminding stakeholders that the third and last registration deadline for existing chemicals manufactured or imported in the EU/ European Economic Area (EEA) from one to 100 tonnes a year is on May 31, 2018. To benefit from the extended deadline for registering, substances must be pre-registered. According to ECHA, many companies did so by the original December 2008 pre-registration deadline. Companies that have recently started to manufacture or import a non-CMR phase-in substance in amounts of one to 100 tonnes a year can pre-register within six months after starting the activity. The last possibility is on May 31, 2017. Pre-registration enables companies to continue supplying low-volume chemicals legally on the EU/EEA market until the registration deadline. Companies that do not have a valid pre-registration or registration for a substance after May 31, 2017, will need to submit an inquiry to ECHA and register the substance before manufacturing or importing it. More information is available in ECHA’s November 16, 2016, press release, “Last call to pre-register your low volume chemicals.”

ECHA Updates Interactive Guide On SDSs And Exposure Scenarios: ECHA announced on November 16, 2016, the availability of an updated interactive guide that provides information for the recipients of SDSs and exposure scenarios in a user-friendly way. ECHA updated it to include useful tips for suppliers on issues to watch out for within each section. Advice is given on how to provide and use SDS information to help protect human health and the environment throughout the supply chain. The interactive guide includes:

  • Examples of SDSs and exposure scenarios;
  • Clear descriptions of what information is contained in each section of the SDS and exposure scenario;
  • Advice to the reader on what to do to promote safe use and regulatory compliance;
  • Tips for suppliers on information that downstream users need;
  • Tips for recipients on actions they may need to take based on the information received;
  • An indication of where to find the most frequently asked questions; and
  • Supplementary information and useful links to other relevant sources.

More information is available in ECHA’s November 16, 2016, press release, “Updated interactive Guide on safety data sheets and exposure scenarios available.”

EC’s Biocides Committee Supports Five Active Substance And Product-Type Approvals: On November 17, 2016, the EC’s Standing Committee on Biocidal Products supported the approval of the following active substance and product-type combinations:

  • Lactic acid for product-type one;
  • Peracetic acid for product-types 11 and 12;
  • Epsilon-momfluorothrin for product-type 18; and
  • Piperonyl butoxide for product-type 18.

More information is available in the “Draft Agenda” for the 50th Meeting of the EC’s Standing Committee on Biocidal Products.

ECHA Newsletter Addresses Nano Observatory: ECHA’s November 2016 Newsletter includes an article entitled “Nanomaterials -- angels or demons?” that discusses why the EC decided to set up an observatory for nanomaterials instead of a registry. The article includes comments from Otto Linher, Deputy Head of Directorate General Enterprise’s chemicals unit, and Jukka Malm, ECHA Deputy Executive Director. Linher states that creating a registry would be “extremely burdensome and expensive.” According to Linher, it is more important that the observatory provide an overview of where nanomaterials can be found in general and tell users what the presence of nanomaterials actually means for them.

EC’s Revised EDC Criteria Continue To Receive Criticism From Industry And Member States: Following comments from Member States, the EP, ECHA, scientists, and non-governmental organizations (NGO), the EC sent revised proposals regarding criteria for identification of endocrine disrupting chemicals (EDC) under the Biocidal Products Regulation and the Plant Protection Products Regulation to Member States. Generally, Member States and NGOs have expressed disappointment with the revised criteria.

The Pesticide Action Network (PAN) Europe stated “[o]ur conclusion is that the amendments made by [the EC] on the original proposal of June 2016, are largely cosmetic. The amended proposal keeps on being based on a ‘risk’ approach, as opposed to the ‘hazard’ approach in the Regulation 1107/2009 … The biggest change made in the amended proposal is substituting ‘known to cause an adverse effect relevant to humans’ back to ‘may cause adverse effects’ … Despite this change, the level of proof remains [extremely] high, higher than for any other dangerous chemical in Europe.” The International Chemical Secretariat (ChemSec) stated “[t]he process has been long and controversial and the legal deadline for establishing the criteria has soon been passed by three years.”

The revised criteria have received criticism for not addressing concerns of Member States and industry, including the exclusion of “presumed” EDCs from the World Health Organization (WHO) definition. At the November 18, 2016, meetings of the Standing Committee on Plants, Animals, Food and Feed (PAFF) and the Expert Group of Competent Authorities for Biocides, a significant number of Member States had no formal position on the EC’s revised EDC criteria because of ongoing national-level discussions.

EU Reaches Agreement On Conflict Minerals Regulation: On November 22, 2016, the EP, the Council of the EU, and the EC agreed on a draft regulation on conflict minerals that would require all but the smallest EU importers of tin, tungsten, tantalum, gold, and their ores to do due diligence checks on their suppliers, and big manufacturers will have to disclose how they plan to monitor their sources to comply with the regulation. According to the EC’s November 22, 2016, press release, “EU reaches landmark agreement on conflict minerals regulation,” the regulation will ensure sustainable sourcing for more than 95 percent of all EU imports of tin, tantalum, tungsten, and gold, which will be covered by due diligence provisions as of January 1, 2021. Due diligence checks, in accordance with Organization for Economic Cooperation and Development (OECD) guidelines will be mandatory for importers of tin, tungsten, tantalum, gold, and their ores from conflict and high-risk areas. Authorities in EU Member States will be responsible for ensuring compliance by companies and also for determining penalties for non-compliance, to be monitored by the EC. The smallest importers (e.g., dentists and jewelers) will be exempt from the scheme, so as to avoid unreasonable bureaucratic burdens. Recycled metals, existing EU stocks, and by-products will also be excluded. In its November 22, 2016, press release, the EP states that it secured an EC declaration ensuring close monitoring of the gold market and EU gold imports to mitigate negative side effects. Big EU firms -- i.e., those subject to non-financial reporting (above 500 employees) -- that buy tin, tantalum, tungsten, and gold to use in their products will be encouraged to report on their sourcing practices based on new performance indicators. These businesses will be able to join an EU registry and report voluntarily on their due diligence practices. The EC will review and report to the EP and Council of the EU on the effectiveness of the regulation two years after the date from which it applies and every three years afterwards. The regulation must now be adopted by the Council of the EU and the EP. More information is available in the EP’s November 22, 2016, press release, “Conflict minerals: MEPs secure mandatory due diligence for importers.”

Court Of Justice Finds Confidentiality May Not Be Invoked To Preclude Disclosure Of Environmental Documents: On November 23, 2016, the Court of Justice of the EU issued a press release regarding two cases addressing the right of access to environmental documents. In Case C-673/13 P, two NGOs submitted a request to the EC, on the basis of Regulation (EC) No 1367/2006, for access to documents relating to the initial marketing authorization for glyphosate. The EC granted access to the documents, with the exception of part of the draft assessment report prepared by Germany. The EC justified its refusal, stating that the document in question contained confidential information on the intellectual property rights of the applicants for the glyphosate authorization. The NGOs brought an action before the General Court of the European Union for annulment of the EC’s decision. In its October 8, 2013, decision, the General Court found that parts of the document at issue contained information related to emissions into the environment and should have been released. The EC asked the Court of Justice to set the ruling aside.

In Case C-442/14, Bijenstichting, a Dutch bee-protection association, submitted a request to the College voor de toelating van gewasbeschermingsmiddelen en biociden (CTB), the Netherlands authority responsible for authorizing the marketing of plant protection products and biocidal products, for disclosure of 84 documents concerning marketing authorizations issued by CTB for certain plant protection products and biocides. Bayer, holder of a large number of the authorizations, objected to disclosure on the ground that it would infringe copyright and adversely affect the confidentiality of commercial or industrial information. CTB authorized the disclosure of 35 of the 84 documents requested, on the grounds that they contained information on emissions into the environment, even though such disclosure could have an adverse effect on the confidentiality of commercial or industrial information. Under Directive 2003/4/EC, commercial and industrial confidentiality may not be invoked to preclude the disclosure of such information. Bijenstichting and Bayer both appealed against CTB’s decision to the Netherlands courts. Those courts referred a number of questions to the Court of Justice, including whether the information requested falls within the concept of “information on emissions into the environment” within the meaning of Directive 2003/4/EC, which would deny Bayer the opportunity to object on the ground that such disclosure could adversely affect the confidentiality of commercial or industrial information. In its November 23, 2016, decision, the Court of Justice clarifies the meaning of “emissions into the environment” and “information on [or which relates to] emissions into the environment” under Regulation (EC) No 1367/2006 and Directive 2003/4/EC.

In both cases, the Court finds that “the concept of ‘emissions into the environment’ includes the release into the environment of products or substances, such as plant protection products or biocides or active substances contained in those products, to the extent that that release is actual or foreseeable under normal or realistic conditions of use of the product or substance.” The Court notes, therefore, that this concept is indistinguishable from the concepts of “release” and “discharge” and cannot be restricted to emissions emanating from industrial installations, but also covers emissions resulting from the spraying of a product, such as a plant protection product or biocide, into the air or its use on plants, in water, or on soil. The Court also confirms that Regulation (EC) No 1367/2006 and Directive 2003/4/EC cover information on foreseeable emissions from a plant protection product or biocide into the environment. The Court states that the concept of information on emissions into the environment “does not include information relating to purely hypothetical emissions, such as, for example, data from tests to study the effects of the use of a dose of a product which is significantly above the maximum dose for which the marketing authorisation was granted and which is used in practice.” According to the Court, the concept of “information on emissions into the environment” must be interpreted as covering not only information relating to the nature, composition, quantity, date, and place of those emissions, but also information enabling the public to check whether the assessment of actual or foreseeable emissions, on the basis of which the competent authority authorized the product or substance, is correct, as well as the data relating to the medium- or long-term effects of those emissions on the environment. The Court states that, in particular, that concept covers information relating to the residues in the environment after the product has been used and studies on the measurement of the substance’s drift during that use, whether those data come from studies performed entirely or in part in the field, from laboratory studies or translocation studies.

In Case C-673/13 P, the Court of Justice set aside the judgment of the General Court, in so far as that court considered that it is sufficient that information relates “in a sufficiently direct manner” to emissions into the environment for it to fall within the scope of the Regulation. The Court of Justice referred the case back to the General Court to determine whether the information at issue does in fact relate to emissions into the environment and, if necessary, rule on the parties’ arguments that were not examined in its judgment.

More information is available in the Court of Justice’s press release, “When a person requests access to environmental documents, the concept of ‘information on emissions into the environment’ covers, inter alia, information concerning the nature and effects of the release of a pesticide into air, water or soil, or onto plants.”

FRANCE

France Notifies EC Of Ban On Microplastics And Cotton Buds With Plastic Stems: France has notified the EC that it will ban “rinse-off cosmetic products for exfoliation or cleaning that contain solid plastic particles” from January 1, 2018. The Decree on microplastics provides definitions for “[c]osmetic product,” “[r]inse-off cosmetic,” “[e]xfoliation,” “[p]article,” and “[s]olid plastic particles.” The Decree states “[e]xception is made for particles of natural origin not liable to persist in the environment, release active chemical or biological ingredients thereinto, or affect animal food chains.” France also notified the EC that it will ban from January 1, 2020, cotton buds for domestic use that have plastic stems. The French Decree on cotton buds defines “[p]lastic” and “placing on the market.”

The Decrees identify “natural or legal persons placing on the market free of charge or in return for payment” the relevant products as the groups concerned. Both Decrees were issued pursuant to Article 124 of Act No 2016-1087 on the Restoration of Biodiversity, Nature and the Countryside.

SOUTH KOREA

OSH Amendments Would Prevent Companies From Changing The Brand Names Of Chemicals: On September 6, 2016, the Ministry of Employment and Labor (MOEL) issued a preliminary announcement in English of amendments to the occupational safety and health (OSH) enforcement regulations and the rules on OSH standards. Under the current enforcement regulations, to protect information on a new chemical, an employer may request that the substance be announced publicly under its brand name. Earlier this year, Reckitt Benckiser publicly apologized for being one of several companies to sell humidifier sterilizer products that caused lung disease and deaths in South Korea. According to the preliminary announcement, during a Parliamentary investigation of the humidifier sterilizer products, it was noted that if an employer changes the brand name of a chemical after the public announcement, employers, workers, consumers, and even government agencies cannot check the changed brand name against the list of substances published. The preliminary announcement states: “To address this problem, employers will be prevented from arbitrarily changing the name of a chemical into any name other than the announced one and required to use generic names that can be cross checked when notifying the Ministry of Environment of new chemicals.” The amendment to the enforcement regulations will also require chemicals’ brand names and Chemical Abstracts Service (CAS) numbers to be announced publicly again once the information protection period has expired.

TAIWAN

Temporary Regulations Will Create New Bureau On Toxic Substances And Chemical Regulation, Executive Yuan Approves Proposal: On October 5, 2016, the Taiwan Environmental Protection Administration (Taiwan EPA) promulgated temporary regulations to create a new bureau on toxic substances and chemical regulation by January 1, 2017. The bureau’s duties will include forming, implementing, and enforcing policies on chemical substance regulation, toxic substance regulation, chemical accidents and emergency response, and environmental agent regulation. The bureau will also promote the integration and use of chemical information; technological advances related to toxic chemical regulation; and international cooperation on chemical substance regulation. According to Taiwan EPA Vice Minister Chan Shun-kuei, the current legislative session will first review and approve the budget for the central government before passing significant new legislation. To submit the 2017 budget for the new bureau for legislative review, Taiwan EPA first needed to promulgate temporary regulations. Chan stated that the temporary regulations will be in effect only until the legislature approves a draft law for the bureau and the law is signed by President Tsai. On November 3, 2016, the Executive Yuan approved a draft bill, Organization Rules of the Bureau for Toxics and Chemical Substances, which would establish the bureau. On November 30, 2016, the bill passed the Legislative Yuan’s Judicial and Legal Affairs Committee in its first reading. According to Democratic Progressive Party (DPP) Legislator Yu Mei-nu, Co-Convenor of the Committee, the bill should soon be listed on the legislative agenda for its second reading and final passage in a third reading.

THAILAND

Deadline Approaches To Nominate Chemicals To Preliminary Inventory Of Existing Chemicals: As reported in The Acta Group (Acta®) November 18, 2016, memorandum, “Deadline Approaches to Nominate Chemicals to Thailand’s Inventory of Existing Chemicals,” the first stage nomination deadline for chemicals not listed on the preliminary inventory of existing chemicals (Preliminary of Thailand Existing Chemicals Inventory) is December 31, 2016. The nomination of additional substances can be electronically accomplished through a portal maintained by Department of Industrial Works (DIW) or through direct consultation with DIW. DIW expects to publish a final Thailand Existing Chemicals Inventory in 2017. Chemicals not listed on the final Existing Chemicals Inventory would be considered new chemicals. More information is available, in Thai, on DIW’s website.

TURKEY

Turkey Adopts Toy Safety Regulation: Turkey has announced that it will implement a “Safety of Toys Implementing Regulation” starting April 4, 2017. The Regulation replaces the existing law from 2013 and mirrors the EU's Toy Safety Directive. The Regulation aligns the number of controlled metals and their maximum limits with the permissible levels in the EU and does not apply to the following:

  • Playground equipment intended for public use;
  • Automatic playing machines, whether coin operated or not, intended for public use;
  • Toy vehicles equipped with combustion engines;
  • Toy steam engines; and
  • Slings and catapults.

The Regulation also lists in Annex I products that are not considered toys according to the Regulation. The Annex I list includes “[p]uzzles with more than 500 pieces,” “[d]ecorative objects for festivities and celebrations,” and “[s]cooters and other means of transport designed for sport or which are intended to be used for travel on public roads or public pathways.”

The Regulation places obligations on manufacturers, importers, distributors, and authorized representatives. Under the Regulation, 19 metals are restricted in toys and permissible limits are reduced for metals already restricted under Turkey’s previous regulatory framework for toy safety.

The Regulation prohibits substances or mixtures classified as CMR, except in certain situations. Additionally, the Regulation lists 55 allergenic fragrances that “[t]oys shall not contain.” Among the listed allergenic fragrances are Benzyl cyanide, Diethyl maleate, and Dihydrocoumarin.

Regarding “Hygiene,” the Regulation states “[t]oys must be designed and manufactured in such a way as to meet hygiene and cleanliness requirements in order to avoid any risk of infection, sickness or contamination … A toy intended for use by children under 36 months must be designed and manufactured in such a way that it can be cleaned. A textile toy shall be washable, except if it contains a mechanism that may be damaged if soak washed.”

UNITED KINGDOM (UK)

CIA Issues Statement On Brexit: The Chemical Industries Association (CIA) has issued a document entitled “Exiting the [EU]: The UK Chemical Industry – Britain’s Growth Engine – A Vision for a Post-Brexit Future.” CIA stated that “[t]he government has announced it will repeal the European Communities Act and transfer the body of existing EU law into UK law, with decisions to be addressed in the future about which legislation will remain and which should be repealed or amended. This provides opportunities and challenges. CIA is already working with regulators and the Government on all relevant aspects of this, including for example REACH, [the EU Emissions Trading Scheme (ETS)] and the Industrial Emissions Directive.”

In the document, CIA indicates that its “key priorities” in the UK’s departure from the EU are tariff-free access to the single market; the availability of skilled people; the supply of competitive energy; and a policy framework that encourages scientific progress that will lead to sustainable growth. CIA stated that “[t]he most immediate issue is to retain free market access to the single market.” CIA expresses the opinion that in the long term this can be achieved through a free trade agreement, and that the UK should apply, as a transition arrangement, to retain its Customs Union membership. Additionally, CIA suggested that the UK should set out a draft schedule of tariffs and quotas based on current EU Most Favored Nation (MFN) levels to gain access to MFN benefits “currently enjoyed” by EU members with third countries and to have access to World Trade Organization (WTO) dispute settlement procedures.

Regarding the availability of skilled people, CIA stated “[c]hemical and pharmaceutical companies understand the importance of providing local economic benefits including employment, but for a variety of business reasons, including skill shortages, need access to the global talent pipeline. ‘Getting the best can help secure employment for the rest.’”

CIA identified energy as a key concern and suggested that the UK should: (1) retain “[f]ree and fair access to the EU’s single energy market”; (2) seek low cost alternatives to the EU’s ETS or “at least a post-2020 framework which will [minimize] production and investment leakage from energy intensive industries like chemicals”; (3) minimize UK energy related policy costs; and (4) develop unconventional gas.

Regarding a suitable policy framework, CIA stated that the UK needs a long-term guarantee of programs that fill any gap created by potential loss of European funding. CIA indicated that such measures will allow UK businesses to continue to build partnerships, have equivalent opportunities to lead developments in technology and innovation, and continue to encourage highly skilled scientists and technologists to come to the UK.

CIA stated “[o]ur departure could provide circumstances for more [favorable] regulation, using a risk-based approach and a respect for sound science that fosters innovation, for example in areas such as nanomaterials and shale gas exploitation.”

Brexit has become an increasingly complex, continuously evolving, and highly debated process. The Supreme Court case to decide whether Members of Parliament are required to authorize the trigger of Article 50 of the Lisbon Treaty by the UK has commenced, and a verdict is expected in January 2017. Acta has actively followed and continues to monitor diligently Brexit-related developments and their potential implications for its clients. More information is available in Acta’s December 1, 2016, memorandum entitled “Brexit -- An Overview of Transformative Developments and Their Potential Impact on European Chemical Laws.”

VIETNAM

Vietnam Publishes Draft National Chemicals Inventory: In September 2016, the Ministry of Industry and Trade (MOIT) published a draft National Chemicals Inventory for public comment. The draft Inventory includes over 3,000 chemicals. After MOIT issues a final National Chemicals Inventory, chemicals not listed will be considered new, and companies will be required to perform an assessment and register the new chemical before import or manufacture. Comments were due October 30, 2016. More consultations may be held in the future.


 
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