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March 1, 2017

Global Regulatory Update for March 2017

The ACTA Group


Argentina Seeking To Modernize Environmental Regulatory System: The Argentinian Ministry of Environment and Sustainable Development (Ministerio de Ambiente y Desarrollo Sustentable, the Ministerio) has begun the process of reviewing and revamping various aspects of its environmental regulatory system. Continuing a regional trend, which shows increased stakeholder involvement in environmental and related regulatory development processes, the Ministerio has established a web-based portal to solicit public comments on some aspects of the proposed development.

The portal, located at, presently contains only one topic on which to comment, the “Public Consultation on Hazardous Waste (RRPP).” The portal appears to be experiencing connection issues, however. The Ministerio asks respondents to complete a 16 question survey covering hazardous waste, whether existing requirements under the laws are still appropriate and applicable, international conventions such as Basel, and the overall lifecycle of producer responsibility (e.g., the so-called “cradle to grave” management of waste). Answers may be submitted anonymously, and are stated to be considered when drafting the new law.


Brazil Provides Update On Industrial Chemicals Regulation Implementation Timeline: The Brazilian Chemical Industry Association (Associação Brasileira da Indústria Química, ABIQUIM) has informed its members that the timeline for legislative consideration of the Industrial Chemicals Regulation (Regulação de Substâncias Químicas Industriais) has been frozen by the Ministry of Environment (Ministério do Meio Ambiente, MMA) due to the First Intersessional Meeting of The Strategic Approach to International Chemicals Management (SAICM), which was held in Brasilia during the week of February 6, 2017. The MMA is a contributing and active member of SAICM.

Furthermore, the MMA has canceled the National Commission of Chemical Safety (Comissão Nacional de Segurança Química, CONASQ) extraordinary meetings scheduled for January, February, and March. CONASQ is coordinated by the MMA and the Vice-Coordinator of the Ministry of Health. Currently, it is composed of 22 institutions from public, private, and non-governmental organizations. During at least one of these meetings, the review of the public comments received (over 250) was to have begun. Based on this information, the earliest the review can/will begin is April, but even that is not firm due to other legislative priorities.

A new timeline for implementation of the Regulation could be announced during the April 2017 meeting.


China Adopts Regulation On Pesticide Administration (Revised Draft): The Chinese State Council adopted the “Regulation on Pesticide Administration (Revised Draft)” on February 8, 2017. The final version of the new regulation is expected to be issued in the coming weeks and the effective date is expected to be July 1, 2017. It has been more than five years since the initial draft revision was published for public comments on July 20, 2011. Based on the press release by the State Council, the new regulation has significant changes to ensure the quality and safety of agricultural products, compared with the current “Regulation on Pesticide Administration” that was promulgated on May 8, 1997, and amended on November 29, 2001. The key changes in the new regulation are as follows:

  • Streamline the administration process.
    • Pesticides will now be administered by the Ministry of Agriculture (MOA), instead of multiple ministries.
    • Licensing systems for pesticide production and operation will be implemented.
    • Promote the reduction of pesticide uses and enhance the management of highly toxic pesticides.
  • Clarify the responsibilities.
    • Manufacturers and marketers are responsible for the safety and efficacy of pesticides.
  • Prevent and punish adulteration of pesticides and enhance enforcement.
    • Increased fines and blacklisting are included to strengthen the punishments for adulteration.
  • Revise the registration process.
    • Temporary pesticide registration is no longer an option.
    • Registration holder is allowed to transfer its registration information but not the registration certificate to others.
    • Exemption of residue and environmental tests is allowed for registration of pesticides with the same composition and applications as a registered pesticide, but authorization by the registration holder is required for the registered pesticide within the protection period (six years from the date of registration).
  • Revise pesticide labeling requirements.
    • All pesticide labels must be approved by the MOA.
    • False or misleading labeling is not allowed.
    • Changes to approved label content are not allowed without approval by the MOA.
  • Improve the recording and tracking system of pesticide uses.
    • Manufacturers of agricultural products, operators of food and edible agricultural product warehouses, organizations of pest control services, and farmers’ cooperatives must maintain the required records for at least two years.
  • Establish the pesticide waste recycling and pesticide recall systems.
    • Manufacturers and sellers are responsible for the recycling of pesticide wastes and recalling timely pesticides deemed to have serious toxicity or great risk.

The regulation requires the MOA to formulate the relevant rules and measures for its implementation, but does not provide an implementation date.


Colombia Proposes Regulation Of Industrial Use Chemicals: The Colombian Ministry of Health, along with the Ministry of Labor, Ministry of Commerce, and the Ministry of Environment, have collaborated on a draft decree that lays out requirements for those manufacturing or importing chemicals for use in industrial applications. These entities would be required to develop “self-management” mechanisms, as well as related information-management systems, to protect both the workers and others who use the products, and the environment as well. The manufacturers and importers would potentially be subject to a host of requirements, including substance registration, the development of risk management programs, and self-assessment processes.


Multiple Costa Rican Ministries Jointly Propose National Chemical Safety Policy: The Costa Rican Ministries of Health, Environment, Exterior Relations, Agriculture, Labor, and Finance have promulgated legislation that established the National Chemical Safety Policy in the country. Executive Decree No. 40148-S-MINAE-MAG-MTSS-RE-H focuses largely on developing the concept of a lifecycle analysis and management for the use of chemical substances in the country, with the manifest goal of reducing adverse effects on both the natural environment and human health.


EC Announces New Initiative To Improve Health And Safety Of Workers, Proposes Changes To Carcinogens And Mutagens Directive: On January 10, 2017, the European Commission (EC) announced that it is taking action to promote occupational safety and health in the EU. According to the EC, its new initiative aims to protect workers better against work-related cancer, to help businesses, in particular small- and medium-sized enterprises (SME) and micro-enterprises, in their efforts to comply with the existing legislative framework, and to put a bigger focus on results and less on paperwork. The EC will undertake the following actions:

  • Set exposure limits or other measures for another seven cancer-causing chemicals;
  • Help businesses in their efforts to comply with health and safety rules. The EC published a guidance paper for employers with practical tips aimed at facilitating their risk assessment and at making it more effective; and
  • The EC will work with EU Member States and social partners to remove or update outdated rules within the next two years. The aim is to simplify and reduce administrative burden, while maintaining workers’ protection. This modernization should also support better enforcement on the ground.

The fact sheet lists the sectors, types of cancer caused, and estimated exposure levels for the seven cancer-causing chemicals under consideration: epichlorohydrin; ethylene dibromide; ethylene dichloride; 4,4’-methylenedianiline; trichloroethylene; complex polycyclic aromatic hydrocarbon mixtures with benzo[a]pyrene as an indicator; and used engine oils. More information is available in the EC’s January 10, 2017, press release, “Commission launches new initiative to improve health and safety of workers.”

RAC And SEAC Support 1,2-Dichloroethane Authorization: On January 17, 2017, the Committee for Risk Assessment (RAC) and the Committee for Socio-economic Analysis (SEAC) issued in final the “Opinion on an Application for [Authorization] for Use of 1,2-Dichloroethane: Use as an extraction solvent in the de-waxing of petroleum vacuum distillates and deasphalted oil and de-oiling of slack wax for the production of base oils and paraffinic waxes.”

Grupa Lotos S.A. (Grupa) submitted the application for authorization of 1,2-dichloroethane in February 2016. Grupa uses a mixture of 1,2-dichloroethane and dichloromethane in a “closed loop process to dilute a waxy raffinate in conjunction with refrigeration to crystallize out the wax which is then filtered.” The three main steps in Grupa’s process for the substance are crystallization, filtration, and solvent recovery. Through this “de-waxing process,” Grupa generates three grades of base oils and three grades of slack waxes. According to Grupa, the concentration of 1,2-dichloroethane in its products is well below 0.001 percent, and therefore workers in downstream life cycle stages or consumers are considered not to be exposed to the substance.

SEAC stated that there appear to be no suitable alternatives to 1,2-dichloroethane “in terms of their technical and economic feasibility for the applicant.” SEAC did not “raise any reservations that would change the validity of the applicant’s conclusion that overall benefits of the use outweigh the risk to human health, whilst taking account of any uncertainties in the assessment, provided that the suggested conditions and monitoring arrangements are adhered to.”

RAC opined that the application for authorization contained the necessary information under Article 62 of REACH that is relevant to the Committee’s remit. RAC confirmed that it is not possible to determine a derived no-effect level (DNEL) for the carcinogenic properties of the substance in accordance with Annex I of REACH. RAC concluded that “the operational conditions and risk management measures described in the application limit the risk, provided that they are adhered to along with the suggested conditions and monitoring arrangements.”

RAC and SEAC recommended a 12-year review period for the use of 1,2-dichloroethane.

EC Starts Evaluation Of ECICS: On January 19, 2017, the EC issued its Roadmap for “Evaluation of the European Customs Inventory of Chemical Substances (ECICS).” The planned start date for the evaluation is the first quarter of 2017, and the planned completion date is the fourth quarter of 2017.

The purpose of the evaluation is to assess the effectiveness, efficiency, relevance, “EU added-value and sustainability of [ECICS],” and its coherence “vis-à-vis other existing databases.” As a justification for the evaluation, the EC stated that since ECICS’ publication in 1974, it has been “constantly extended” but no evaluation has been carried out. Therefore, the EC provides, that “it is useful to assess how well this database has performed since its creation and whether its existence continues to be justified.”

In relation to “effectiveness,” the Roadmap provides that the evaluation will consider the extent to which expectations set by immediate stakeholders (e.g., customs authorities, economic operators) have been met by ECICS content and design, and assess whether improvements or changes are needed. Regarding “efficiency,” the Roadmap provides that the evaluation will consider the extent to which the resources (i.e., human and financial) devoted to evolution of the database are “proportionate to the benefits” to the EU trading community, customs administrations, and EU agencies and departments.

The evaluation will consider the complementarity and value added by ECICS in consideration of other databases (e.g., Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), European Database on New Drugs (EDND)). Regarding “relevance,” the evaluation will consider the extent to which ECICS is still justified, and the reasons for justification.

Draft REACH Guidance Documents On Nanomaterials Move To CARACAL For Review: According to the European Chemicals Agency (ECHA) website, several REACH guidance documents concerning nanomaterials have moved to the next step in the consultation process. The draft recommendations for nanomaterials applicable to the guidance on quantitative structure-activity relationships and grouping of chemicals was sent to the Competent Authorities for REACH and Classification, Labeling, and Packaging (CLP) (CARACAL) on January 23, 2017. On January 31, 2017, the draft appendices on recommendations for nanomaterials for environmental endpoints were sent to CARACAL:

The draft Guidance on information requirements and Chemical Safety Assessment: Appendix R7-1 Recommendations for nanomaterials applicable to Chapter R7a Endpoint specific guidance and Appendix R7-2 Recommendations for nanomaterials applicable to Chapter R7c Endpoint specific guidance was sent to CARACAL on February 23, 2017. The guidance focuses on specific recommendations for testing materials that are nanomaterials. Summaries of comments from earlier stages of the consultation process are available on ECHA’s website.

EP Committee Amends Draft Waste Package Legislation: On January 24, 2017, the European Parliament (EP) Environment, Public Health, and Food Safety Committee amended the draft EU waste package legislation. According to the Committee’s press release, the share of waste to be recycled should be raised to 70 percent by 2030, from 44 percent today, while landfilling, which has a big environmental impact, should be limited to five percent. The Committee also advocated a 50 percent reduction in food waste by 2030. The press release states that statistics from 2014 suggest that 44 percent of all municipal waste in the EU is recycled or composted. This compares to just 31 percent in 2004, and by 2020, EU Member States should be recycling or composting over 50 percent of waste. The proposals in the package will be put to a vote by the full House at the March 13-16, 2017, plenary session. More information is available in the Committee’s January 24, 2017, press release, “Waste: boost recycling, cut landfilling and curb food waste, say MEPs.”

EP Committee Approves Draft Conflict Minerals Rule; Japanese Industry Requests More Clarity: On January 24, 2017, EP’s International Trade Committee approved a draft conflict minerals rule. Under the draft rule, beginning in January 2021, importers, smelters, and refiners of tungsten, tin, tantalum, and gold will have to conduct out mandatory due diligence checks when annual import volumes exceed set thresholds. While there will be no mandatory requirements on downstream companies in the supply chain, they will be encouraged to carry out voluntary checks. The EP will vote on the draft rule during its March 2017 plenary session. The Council of the EU will then confirm the rule, and it will then be published in the Official Journal of the European Union.

On February 17, 2017, the Japan Business Council in Europe and Japan Electronics and Information Technology Industries Association published a joint statement on the agreed text of the rule, requesting:

  • Timely disclosure by the EC of the planned handbook on “conflict-affected and high-risk”;
  • More clarity regarding how the EC’s non-exhaustive list of conflict-affected and high-risk areas will be aligned with outsourced projects and other initiatives that would define conflict-affected and high-risk;
  • Synchronization of the listing and delisting of responsible smelters/refiners with the EU-recognized supply chain due diligence industry schemes; and
  • Focus on importers and clear criteria for the certification of responsible importers, smelters, and refiners.

Cefic Issues Report On Horizon 2020: On January 24, 2017, The European Chemical Industry Council (Cefic) issued a press release entitled “Chemical sector responds to Horizon 2020 interim evaluation consultation.” The press release indicates that in its report, Cefic welcomes the achievements of the Horizon 2020 Framework Funding Program, but “calls for strong commitment to ensure that the [program] translates into industrial competitiveness, furthers the development of Key Enabling Technologies (KET), [reinforces] intellectual property strategy and [increases] successful industrial participation in order to deliver impact for Europe.”

Cefic’s report provides the following “key messages” in its interim evaluation of Horizon 2020, the “financial instrument implementing the Innovation Union”:

  • Innovation is important for future EU industrial competitiveness. Horizon 2020 promotes Research and Innovation (R&I) over a wide spectrum of research themes. Cefic recommends allocation of funds to projects representing a carefully determined balance between R&I; projects that are significant in size; and projects that are “future defining” in nature.
  • “Societal Challenges” drive R&I programs to reach the market across value chains. Calls under the current Societal Challenges pillar are broad and generic. Cefic recommends “sharper definition” and addition of implementation plans with a focus on KETs.
  • Intellectual Property strategy is critical to R&I projects. The current default co-ownership of jointly developed research results and Open Science approach require fine tuning to ensure that Horizon 2020 remains attractive for the private sector.
  • Industry participation is essential to “turn ideas into value in the market.” Cefic believes Horizon 2020’slow project success rate is “discouraging participation by business research.” Increased budget allocations to public-private partnerships can address private sector participation in a network, including large companies and SMEs.

Cefic stated “[l]ooking forward beyond the Horizon 2020 [program], Europe should continue to improve its global competitiveness and power to [innovate].”

ECHA Shortlists 162 Substances For Possible Regulatory Action: ECHA announced on January 25, 2017, that it selected 162 substances from REACH registrations for further scrutiny by the Member State competent authorities in its annual IT screening exercise. According to ECHA, the competent authorities will carry out a manual examination of the dossiers they prioritize to decide whether regulatory action is needed. ECHA states that the selection is based on an automated IT screening focusing on substances with potential carcinogenic, mutagenic, or toxic to reproduction (CMR), persistent, bioaccumulative, and toxic (PBT), endocrine-disrupting, sensitizing, or specific target organ toxicity following repeated exposure properties. Potential substances with these hazardous properties were then further prioritized based on uses that are likely to lead to exposure to humans or release to the environment. The Member State competent authorities will select substances from the shortlist for their manual examination. According to ECHA, companies that registered one of substances now shortlisted will receive a letter from ECHA informing of the potential examination of their registration(s). ECHA encourages companies to update their dossiers to address any shortcomings as soon as possible. Up-to-date information will help the Member State authorities better assess whether the concern indicated by the screening is confirmed, and whether regulatory action is still needed. ECHA held a webinar on February 14, 2017, during which it provided more details about the screening process. ECHA states that it “does not make the list of shortlisted substances public as it is purely based on automated selection by IT and manual verification is needed to confirm a potential concern.” More information is available in ECHA’s January 25, 2017, press release, “162 substances shortlisted for possible regulatory action.”

EC Adopts RoHS 2 Legislative Proposal: On January 26, 2017, the EC adopted a legislative proposal that would amend the scope of Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (EEE) (RoHS 2). According to the proposal, in the absence of an amendment, the following problems would arise after July 22, 2019:

  • The interdiction of secondary market operations (e.g., reselling, second-hand market) for new-in-scope EEE;
  • The stop of the possibility to repair with spare parts a subset of new-in-scope EEE once legally placed on the market before that date;
  • The different (distorting) treatment of cord-connected non-road mobile machinery in comparison to otherwise identical machinery powered by a battery or an engine (currently excluded from Restriction of Hazardous Substances (RoHS) scope); and
  • The de facto prohibition of pipe organs placement on the EU market (as not RoHS-compliant due to the lead used to produce the wanted sound).

The EC’s proposal addresses the following scope problems that cannot be resolved by either substance substitution or exemptions and guidance, e.g., for specific product groups with permanent compliance problem or where scope provisions generate market distortions:

  • Secondary market operations for RoHS 2 EEE that fell outside the scope of Directive 2002/95/EC (RoHS 1);
  • Spare parts for RoHS 2 EEE that fell outside the scope of RoHS 1;
  • Traction-drive cord-connected non-road mobile machinery; and
  • Pipe organs.

The proposal also addresses lessons learned from implementing RoHS 2, in line with its overall objectives and legal clarity requirements. The EC has posted an impact assessment and preparatory RoHS 2 scope review studies.

EC Publishes Roadmap On Analysis Of Interface Between Chemicals, Products, And Waste Legislation And Identification Of Policy Options: The EC published a Roadmap on January 27, 2017, on an analysis of the interface between chemicals, products, and waste legislation and identification of policy options. The analysis is intended “to develop policies that can deliver circular economy through a seamless flow of materials recycled from waste as suitable raw materials back into the economy.” The Roadmap states that four issues have been identified that create obstacles for a smooth transition of recycled materials from waste to new products:

  1. Insufficient information about substances of concern in products and waste;
  2. Presence of substances of concern in recycled materials and in articles made thereof;
  3. Uncertainties about how materials can cease to be waste; and
  4. Difficulties in applying EU waste classification methodologies and impacts on the recyclability of materials.

The Roadmap states that the Communication will present a detailed analysis of the legal, technical, or practical problems at the interface of chemical, product, and waste legislation that may be unnecessarily hindering the transition of recycled materials into fit-for-purpose products that can be reintroduced into the productive economy. The Communication will also identify options to facilitate recycling and improve the uptake of secondary raw materials through the promotion of non-toxic material cycles and better tracking of chemicals of concern in products. The EC expects consultation with stakeholders to provide further insights regarding the problems outlined and how to address them. At a later stage, following an analysis of the feedback received from stakeholders, the results of new studies, and the on-going evaluations, the EC will make proposals to address barriers or short-comings detected, while preserving the high level of protection of human health and the environment, in the rules and processes currently governing the flow of waste-derived materials back into the economy.

EC Directive Establishes Fourth List Of IOELVs: The February 1, 2017, issue of the Official Journal of the European Union includes Directive (EU) 2017/164, which establishes a fourth list of indicative occupational exposure limit values (IOELV) pursuant to Council Directive 98/24/EC. For any chemical substance for which an IOELV has been set at the EU level, Member States are required to establish a national occupational exposure limit value. In doing so, they are required to take into account the EU limit value, determining the nature of the national limit value in accordance with national legislation and practice. According to the Directive, in accordance with Article 3 of Directive 98/24/EC, the Scientific Committee on Occupational Exposure Limits for Chemical Agents (SCOEL) assessed the relationship between the health effects of the chemical agents listed in the 31 entries in the Annex to the Directive and the level of occupational exposure. SCOEL recommended for 31 chemical substances the establishment of IOELVs for the inhalation route of exposure in relation to an eight-hour time-weighted average (TWA). For some of the 31 chemical substances, SCOEL also recommended the establishment of such limit values in relation to shorter reference periods and/or of skin notations. Member States have until August 21, 2018, to bring into force laws, regulations, and administrative provisions necessary to comply with the Directive.

ECHA Consults On Four Applications For Authorization: ECHA has started consultation on applications for authorization of two uses of chromium trioxide and two uses of sodium dichromate.

The consultations for sodium dichromate relate to applications submitted by HAPOC GmbH & Co KG and Gruppo Colle S.r.l for the following uses:

  • Use in molten bath form to modify surfaces, especially by blackening, of delicate medical products, specifically micro-surgical instruments; and
  • Use as mordant in wool dyeing.

The consultations for chromium trioxide relate to applications submitted by Hansgrohe SE for the following uses:

  • Use for electroplating of different types of substrates with the purpose to create a long-lasting high durability surface with bright (shiny) or matte look (functional plating with decorative character); and
  • Use for a pre-treatment step (etching) in the electroplating process.

The deadline for comments in response to ECHA’s consultations is April 5, 2017.

ECHA Announces First Results Of Enhanced Completeness Check: On February 15, 2017, ECHA announced that since it introduced the enhanced completeness check in June 2016, its staff manually verified 1,653 REACH registration dossiers, corresponding to 33 percent of the incoming dossiers. According to ECHA, for 20 percent (329) of the verified dossiers, it asked companies to improve the submitted information. More information was asked mainly on the following (one dossier may need to be improved in many areas):

  • Justifications for waiving data — 136 dossiers;
  • Substance identification — 180 dossiers;
  • Testing proposals — 33 dossiers; and
  • Chemical Safety Reports (CSR) — 11 dossiers.

According to ECHA, almost all registrants (95 percent of dossiers) updated their information as requested and passed the completeness check at their second attempt. For the remaining five percent of cases, ECHA rejected the submission, either because no update was submitted within the given deadline or the second submission failed the completeness check. For initial submissions, the rejection meant that ECHA did not issue a registration number. More information is available in ECHA’s February 15, 2017, press release, “Enhanced completeness check delivers its first results.”

Read-Across Assessment Framework Now Includes Environmental Endpoints: On February 15, 2017, ECHA announced that the Read-Across Assessment Framework now also contains environmental endpoints. According to ECHA, this will help registrants anticipate how ECHA assesses their read-across cases. It will also help registrants to improve their dossiers. ECHA states that registrants can use it to check the quality of their own read-across cases. ECHA’s experts use the framework to assess read-across cases in a consistent and transparent manner. ECHA notes that the framework does not replace the official guidance on read-across for registrants but complements it. ECHA is preparing a document with considerations on read-across involving unknown or variable composition, complex reaction products, or biological materials (UVCB) and multi-constituent substances, and it intends to publish the document in March 2017. More information is available in ECHA’s February 15, 2017, press release, “More clarity for read-across assessment.”

EP Committee Calls For Fast-Track Approval Of Low-Risk Pesticides: On February 15, 2017, the EP Committee on Environment, Public Health, and Food Safety passed a resolution calling for fast-track approval of low risk pesticides. According to the Committee’s press release, the Committee noted that the use of conventional plant protection products “is increasingly subject to public debate, due to the potential risks that they pose for human health, animals and the environment.” Only seven active substances classified as “low risk” alternatives have been approved for use in the EU, however. The press release states that some EU Member States have refused to authorize these low-risk alternatives, “owing to their perceived lower efficacy, without taking account either of their resource efficiency benefits for organic farming or of the environmental and health costs of other products.” The Committee called on the EC to propose draft legislation before the end of 2018 to fast-track the evaluation, authorization, and registration of low-risk pesticides.

Member States Recognize Four Phthalates As EDCs For Humans: At a REACH Committee meeting, a majority of Member States supported Denmark’s proposal for identification of four substances as endocrine-disrupting chemicals (EDC) for humans. The substances are:

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

As a consequence, the substances will be included in the REACH Candidate List of substances of very high concern (SVHC) due to their endocrine-disrupting properties for humans. DEHP is already included in the Candidate List as a suspected EDC for the environment, and all of the substances are already on the Candidate List due to their suspected reprotoxic properties. The substances are used as plasticizers in a wide array of products.

The measure was welcomed by the Health and Environmental Alliance (HEAL) and other non-governmental organizations (NGO). In its press release entitled “Europe finally [recognizes] four phthalates as human endocrine disruptors,” HEAL stated “[we] are very pleased that we’ve finally reached this historic moment: [This] is the first time that the EU REACH system is officially [recognizing] chemicals as being of very high concern because of their endocrine disrupting properties to humans. The next major step is to put away the erroneous fiction that we can reliably establish ‘safe levels’ for endocrine disruptors – and then to regulate them accordingly.”

ClientEarth And EEB Address Hazardous Chemicals In Circular Economy: On February 24, 2017, ClientEarth issued a press release entitled “Laws must work together so the EU can reuse, recycle and repurpose.” ClientEarth stated “we live on a planet with finite resources, so it is essential that our laws pull together to ensure the EU can reuse, recycle and repurpose materials free from dangerous chemicals wherever possible.”

In its press release, ClientEarth identifies hazardous chemicals entering the circular economy as a serious problem that can result in infinite exposure of humans and the environment to toxics, “perpetrating mistakes from the past.” ClientEarth indicates that “to fix this problem,” the following measures should be taken:

  • Limit hazardous chemicals entering the material cycle in the first place;
  • Ensure companies have access to sufficient information on the presence, location, and concentration of hazardous chemicals in products and materials recovered from waste; and
  • “Make sure the laws are equally as protective when products are made from recovered materials as when they’re made from new materials.”

More information is available in ClientEarth and the European Environmental Bureau’s (EEB) report entitled “Keeping it clean: How to protect the circular economy from hazardous substances.”

ECHA Finds Registration Dossiers Still Missing Important Safety Information: On February 27, 2017, ECHA announced the availability of its annual evaluation report. In 2016, ECHA focused its dossier evaluation activities on substances with the greatest potential to affect people and the environment negatively: substances produced in high volumes — over 100 tonnes per year — and with a potential concern. ECHA concluded 184 new compliance checks, most of them on selected substances of potential concern. In 168 cases, according to ECHA, important information was missing. ECHA asked registrants to provide more data on their substances, mostly related to pre-natal developmental toxicity, mutagenicity/genotoxicity, reproduction toxicity, and long-term aquatic toxicity. To encourage registrants to update their dossiers before compliance checks or risk management actions take place, ECHA states that it sent letters to the registrants of 270 substances of potential concern, highlighting the deficiencies in their dossiers. ECHA also regularly published a list of substances that may be chosen for compliance checks. ECHA notes that it revised the registration process, in particular the completeness check, to improve the availability of high-quality information in the incoming registrations. It now includes manual checks for information that cannot be automatically assessed, ensuring that all information intended by REACH has been included in the dossier. ECHA examined 164 new testing proposals and sent 133 draft decisions to registrants. To promote alternatives to animal testing, ECHA now requests registrants submitting testing proposals to provide their considerations on alternatives as part of the registration dossier. A large majority of registrants update their dossiers in line with ECHA’s decisions on compliance checks or testing proposals, providing the missing information. ECHA states that information was still missing or inadequate in only 33 of 355 examined cases, and ECHA invited the Member State authorities to consider national enforcement actions on these registrants. In substance evaluation, ECHA took 26 decisions based on evaluations from previous years. In preparation of further decisions, Member States evaluated 48 substances in 2015-2016 and concluded that 32 required further information from registrants to clarify the suspected concerns. Furthermore, 20 substance evaluation conclusions were published. ECHA states that 11 of them concluded that the risks are sufficiently controlled with existing measures, and nine concluded that EU-wide risk management measures are necessary. More information is available in ECHA’s February 27, 2017, press release, “Important safety information on chemicals still missing.”

EC Fails To Ask PAFF To Vote On Revised EDC Criteria: At a February 28, 2017, meeting, the EC refrained from asking the Committee on Plants, Animals, Food, and Feed (PAFF) to vote on the revised proposed criteria for identification of EDCs because there was no qualified majority supporting the criteria among EU Member States. The EC required 55 percent of the EU countries, representing 65 percent of the EU population, to support the revised EDC criteria to move forward with the proposal.

According to the provisional positions submitted by PAFF members, 11 countries supported the revised EDC identification criteria, while eight countries opposed the criteria, and a further eight countries abstained from providing a vote. Germany, Netherlands, and Spain were among the countries in favor of the proposal. Opposition to the proposed EDC identification criteria derives to a great extent from referral to “negligible exposure,” rather than “negligible risk,” in relation to exceptions for active substances with endocrine disrupting properties. This derogation has been controversial and critiqued by numerous NGOs.

Industry has expressed widespread discontent regarding the EDC identification criteria not being issued in final. At this stage, there is no scheduled date for further discussion on the criteria.

ChemSec Updates SIN List: In February 2017, the International Chemical Secretariat (ChemSec) added 50 chemical substances to the Substitute It Now! (SIN) List:

  • Thirty of the chemical substances were included in the REACH Candidate List in January 2017. ChemSec added Chemical Abstracts Service (CAS) Numbers for the newly agreed group of heptylphenols. ChemSec notes that this is one entry on the Candidate List, but consists of several CAS Numbers. ChemSec also added additional CAS Numbers to existing entries (two salts of nonadecafluorodecanoic acid (PFDA) and three varieties of octylphenol etoxilates), based on the supporting documents for each substance placed on the Candidate List; and
  • Twenty newly classified substances (CMR category 1A or 1B) from the ninth and tenth Adaptations to Technical Progress.

ECHA Starts Consultation On Seven Substances For Inclusion In REACH Annex XIV: On March 2, 2017, ECHA started consultation on the following Candidate List substances for inclusion in the REACH Annex XIV Authorization List:

  • 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof] (karanal group);
  • 1-Methyl-2-pyrrolidone (NMP);
  • 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328);
  • 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327);
  • 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350);
  • 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320); and
  • 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5).

The deadline for submitting comments on ECHA’s consultation is June 2, 2017.

ECHA Board Of Appeal Annuls Contested Decision Concerning Titanium Dioxide: On March 2, 2017, ECHA announced that its Board of Appeal issued its decision in Case A-011-2014, which concerns a REACH dossier evaluation for titanium dioxide. In its evaluation, ECHA considered only the substance identity information required and not the information requirements for human health and environmental effects. The Contested Decision required Huntsman P&A UK Ltd (formerly Tioxide Europe Limited), the lead registrant and one of the nine appellants, to provide detailed substance identity information on the crystal phases, nanoforms, and surface treatment of nanoforms covered by its registration. According to the Board of Appeal, the procedures available to ECHA allow for information concerning the toxicological and ecotoxicological properties, and potentially other information, to be considered to ensure that sufficient information is available regarding the hazards and risks posed by the substance. The toxicological and ecotoxicological information in the registration dossier must satisfy the registration requirements set out in REACH with regard to all the bulk forms and crystal phases and/or nanoforms of titanium dioxide covered by the registration. The Board of Appeal concluded that a literal interpretation of the wording of REACH Annex VI Section 2 does not lead to an unreasonable result. The alleged contradiction in this case between the purpose and the wording of Section 2 does not stem from the wording of that provision. It derives, according to the Board, from the compliance check in the present case being limited to substance identity information only. The Board of Appeal annulled the requests for information on the crystal phases and/or nanoforms of titanium dioxide. As the requirement to submit information on nanoforms must be annulled, the Board states that there is no need to examine the requirement to submit information on the surface treatment of such nanoforms. More information is available in Bergeson & Campbell, P.C.’s March 6, 2017, blog item, “ECHA Board of Appeal Annuls Contested Decision Concerning Titanium Dioxide.”


National Assembly Approves Chemical Substance Management Law: The Laos National Assembly approved the “Law on the Management of Chemicals” (the Law) in the legislative session ending November 21, 2016.

While now part of the national law, falling under the purview of the Ministry of Industry and Commerce and containing 81 Articles, the Law is not without its critics and vocal opposition. Members of the Laotian National Assembly maintain that the content of the Law is weak, and that it will not have the intended function of reducing or eliminating the unregulated use of certain chemical substances in the country.

Indeed, some Assembly members have argued that companies should not be allowed to use the chemicals that are listed in the three most dangerous categories, and for which the Law mandates government approval, unless in a project where the Laotian government is involved.

The Globally Harmonized System (GHS) for the classification and labeling of chemicals is not yet implemented in Laos; it is expected to be implemented now that the Law has been promulgated.

An official English translation of the Law is expected shortly.


Mexican Authority Steps Up Enforcement Of NOM “Environmental Health — Biological Exposure Indices For The Personnel Occupationally Exposed To Chemical Substances”: There has been an uptick in the number of companies in Mexico that have been fined by the Secretariat of Labor and Social Welfare (Secretaría de Trabajo y Previsión Social, STPS) for not having the documentation required by NOM-047-SSA1-2011 (NOM-047). NOM-047 is expected by STPS to be part of a company’s health and safety compliance practices.

As a reminder, the new NOM-010-STPS-2014 “Contaminating Chemical Agents in the Work Environment – Inspection, Evaluation and Control” (NOM-010) took effect April 28, 2016. NOM-010 requires all sites that use or handle chemical substances in their workplace must have an updated worker chemical substance exposure study. Failure to have such an updated study can subject the company to a significant fine on a per-worker basis. NOM-010 dovetails with NOM-047 in that the exposure study required under NOM-010 must also include the biological exposure aspects laid out in NOM-047.

The specific aspects of NOM-047 to be aware of include:

  • Biological exposure to chemical substances monitoring on relevant (exposed) workers;
  • Evaluation of the results by a person qualified in interpreting them; and
  • Use of testing laboratory approved by the Secretary of Health to conduct the biological exposure monitoring.


Thailand Department Of Industrial Works Drafting Risk Assessment Regulation: The Thai Department of Industrial Works (DIW) is in the process of drafting a regulation that will speak to risk assessment for both new and existing chemical substances. Notable in such a regulation is expected to be the introduction and incorporation of the concept of SVHCs into the Thai regulatory lexicon.

The draft regulation is expected to develop the criteria to identify SVHCs for substances on the existing chemical inventory, which is expected to be published in mid-2017, and to then prioritize the risk assessment for those substances. Presently, approximately 9,000 substances have been notified to the preliminary inventory. These SVHCs will be prioritized and will include CMRs, PBTs, and very persistent and very bioaccumulative substances (vPvB).

Companies that manufacture or import the substances will be tasked with compiling what the DIW is expected to term “Chemical Risk Assessment Reports.” The proposed tonnage bands for reporting mirror those of several other global reporting schemes: 10-100 tonnes/year, 100-1,000 tonnes/year, and greater than 1,000 tonnes/year. Presuming the legislation comes into force in 2017, the respective years for submitting the reports would be 20252022, and 2020, respectively. Non-Thai legal entities would have to make their submissions through an Only Representative (OR) in the country, similar to how REACH notification is managed in the EU.


CIA Urges Proactive Measures For Brexit: On March 1, 2017, the Chemical Industries Association (CIA) issued a press release entitled “Chemical and Pharmaceutical Industry Tells Chancellor Not to Wait and See.” CIA’s press release followed its submission to the UK Government ahead of its announcement regarding the details of the UK’s Spring 2017 Budget.

In its press release, CIA’s Chief Executive Steve Elliott stated “[t]he chemical and pharmaceutical businesses we represent understand the complexity of the Brexit process and of course want to see the best possible outcome. Independent of that process, however, we believe there are immediate actions that need to be taken by the Chancellor — most notably to address uncompetitive energy costs through the abolition of the carbon floor price and the reform of investment and taxation covering [research and development] tax credits and the Patent Box scheme to encourage innovation. These measures would help kick-start the government’s very welcome commitment to a new industrial strategy … With next week’s budget in mind, we have made seven proposals that we think will help boost all of the economy and in turn deliver taxation receipts for the Chancellor to invest in public services.”

CIA’s proposals address a number of pertinent issues, including the Levy Control Framework, industrial strategies, energy efficiency, the availability of skilled people post-Brexit, and taxation.

CBA Issues Press Release On Brexit And REACH: The UK’s Chemical Business Association (CBA) issued a press release on March 2, 2017, entitled “REACH Must Be Amended to Preserve Access to European Markets.” CBA’s press release states “[in] a stark message for UK Government Brexit negotiators, [CBA] has called for the current REACH provisions to be amended in order to preserve access to European markets for UK chemical distributors … In its submission to the House of Commons Environmental Audit Committee, CBA highlights the potential risk to its distributor member companies once the UK leaves the [EU].”

CBA addressed the need for the status of products already registered by its member companies under REACH in 2010 and 2013 to be clarified. CBA’s Chief Executive, Peter Newport, stated “[‌u]nless the UK Government negotiates revised terms or some sort of opt-in, UK distributors importing substances from outside the [EU] are likely to be denied access to European markets.”

CBA’s submission to the Environmental Audit Committee addresses a number of important issues, including the challenges of transposing REACH into UK law through a Great Repeal Bill, the role of the devolved administrations, enforcement of REACH in the UK post-Brexit, and the possibility for the UK to pursue a “divergent approach” to chemicals policy from the EU after Brexit. More information is available in CBA’s full submission to the Environmental Audit Committee.