European Chemical Policy and Regulation
EUROPEAN UNION (EU)
EFSA Begins Public Consultation On Draft Weight Of Evidence And Biological Relevance Guidance Documents: On March 6, 2017, the European Food Safety Authority (EFSA) announced the availability of two draft guidance documents — the weight of evidence approach and biological relevance of observed effects — for public comment. The draft guidance on biological relevance:
Provides generic issues and criteria when deciding on whether an observed effect is of biological relevance, i.e., is adverse (or shows a positive health effect) or not; and
Clarifies definitions and concepts, such as responses of a biological system to exposure, mode of action and adverse outcome pathways, thresholds, critical effect, modeling approaches, and biomarkers.
The draft guidance on weight of evidence:
Addresses the use of the weight of evidence in scientific assessments using both qualitative and quantitative approaches; and
Proposes a three-step approach for assembling, weighing, and integrating evidence and defines reliability, relevance, and consistency in terms of their contributions to a weight of evidence assessment.
According to EFSA, these documents, together with the guidance on uncertainty assessment, will help to harmonize methodologies across all the areas under EFSA’s remit. EFSA states that “[t]his work will increase the openness, robustness and transparency of our scientific assessments.” EFSA calls for feedback on the draft guidance documents from the international scientific community, European and national risk assessors, risk communicators, and risk managers, as well as EFSA’s stakeholders. EFSA’s Scientific Committee will review the comments and consider them in developing the final versions of these documents. Comments are due May 1, 2017.
ECHA Publishes Document On How To Consider A Read-Across Approach For Multi-Constituent And UVCB Substances: The European Chemicals Agency (ECHA) announced on March 7, 2017, the availability of a new document on using read-across for multi-constituent and unknown or variable composition, complex reaction products, or biological materials (UVCB) substances. The document describes key issues for assessing and addressing the complexity of read-across approaches for these substances, and includes example model cases to illustrate the complexity. More information is available in ECHA’s press release, “How to consider a read-across approach for multi-constituent and UVCB substances.”
EC Begins Consultation For The Evaluation Of ECICS: On March 14, 2017, the European Commission (EC) began a public consultation for the evaluation of the European Customs Inventory of Chemical Substances (ECICS). The EC states that the ECICS allows users to:
Clearly and easily identify chemicals;
Classify them correctly and easily in the Combined Nomenclature; and
Name them in all EU languages for regulation purposes.
The EC seeks the views of businesses, professional associations, public authorities, customs laboratories, international organizations, and any other possible users of the ECICS database. The EC will use the results to shape decisions on the future of the database. Responses are due June 6, 2017.
EP Committee Approves Draft Legislation That Would Boost Recycling: The European Parliament (EP) Committee on Environment, Public Health, and Food Safety adopted draft legislation on March 14, 2017, that would boost recycling, reduce landfilling, and curb food waste. The Committee’s March 14, 2017, press release states that the draft legislation would meet the following targets:
Waste and packaging waste: By 2030, at least 70 percent by weight of so-called municipal waste (from households and businesses) should be recycled or prepared for re-use, (i.e., checked, cleaned, or repaired). For packaging materials, such as paper and cardboard, plastics, glass, metal, and wood, the Committee proposes an 80 percent target for 2030, with interim 2025 targets for each material;
Landfilling: The draft legislation limits the share of municipal waste to be landfilled to ten percent by 2030. The Committee proposes reducing this to five percent, with a possible five-year extension in certain circumstances, for Member States that landfilled more than 65 percent of their municipal waste in 2013; and
Food waste: Food waste in the EU is estimated at some 89 million tonnes, or 180 kg per capita per year. The Committee advocates an EU food waste reduction target of 30 percent by 2025 and 50 percent by 2030, compared to 2014. The Committee proposes a similar target for marine litter.
The EP will now negotiate with the Council of Ministers. More information is available in the Committee’s press release, “Waste: boost recycling, cut landfilling and curb food waste, Parliament says.”
Court Of Justice Rules That REACH Article 57(f) Listing Cannot Be Based Only On Hazards: On March 15, 2017, the Court of Justice of the EU issued its decisions in the cases Polynt v. ECHA (C-323/15 P) and Hitachi Chemical Europe and Polynt v. ECHA (C-324/15 P). The appellants in both cases challenged the General Court’s opinions concerning ECHA’s decision under Article 57(f) of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to list hexahydro-2-benzofuran-1,3-dione (HHPA) and hexahydromethylphthalic anhydride (MHHPA) as substances of very high concern (SVHC). ECHA identified HHPA and MHHPA as meeting the criteria under Article 57(f) and listed them as SVHCs in December 2012. The companies filed suit in General Court, arguing that ECHA was incorrect in its conclusion that HHPA and MHHPA give rise to a level of concern equivalent to category 1 carcinogenic, mutagenic, or toxic to reproduction substances (CMR). According to the companies, the effects of respiratory sensitization are not irreversible, and consumers and workers were not exposed to HHPA or MHHPA. The General Court concluded that REACH Article 57(f) excludes consideration of data other than those regarding the hazards arising from the intrinsic properties of the substances concerned, such as those relating to human exposure reflecting the risk management measures in force, and dismissed both cases. The companies filed appeals in the Court of Justice of the EU. The court ruled that SVHC listing on the grounds of Article 57(f) (equivalence of concern) cannot be based only on hazards. Instead, ECHA must consider other factors, including “data relating to human exposure reflecting the risk management measures in force.”
EP, Council Of The EU Approve Conflict Minerals Regulation: On March 16, 2017, the EP approved a draft conflict minerals regulation by a vote of 558-17 with 45 abstentions. In its March 21, 2017, press release, the EP states that the regulation concerns tin, tungsten, tantalum, and gold and applies to all conflict-affected and high-risk areas in the world, “of which the most obvious examples are the Democratic Republic of the Congo and the Great Lakes region.” The press release states that they achieved their two main objectives:
Make checks binding for smelters, refiners, and importers of minerals and metals. Only the smallest EU importers, such as dentists or jewelers, will be exempt from this obligation; and
The country of origin will not be the only indicator of risk as the EP has also added information on transit or an irresponsible supplier as reasons to trigger a background check.
Beginning January 1, 2021, companies will be required to check their supply chain “to respect human rights and prevent them from contributing to conflicts.” EU countries will be responsible for ensuring companies comply. The press release notes that the regulation will also have an impact beyond the EU, as smelters that want to supply to the European market will have to be certified. According to the EC’s press release, the rule will cover up to 95 percent of imports as of January 1, 2021. In the meantime, according to the press release, the EC and Member States “will work to make sure that the necessary structures are in place to ensure EU-wide implementation.” The press release states that the EU will put in place accompanying measures to support small- and medium-sized importers, and development aid to ensure the rule is effective and has a positive impact on the ground. The EU has also “reach[ed] out to governments in Africa, Asia and beyond to encourage them to source responsibly and eliminate alternative markets for conflict minerals.” The Council of the EU adopted the rule on April 3, 2017. The final step is for the rule to be published in the Official Journal of the European Union, which could occur in three to six weeks.
RAC And SEAC Agree On Restriction Proposal On Four Phthalates And Several Authorization Applications: ECHA announced on March 21, 2017, that the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC) agreed on a restriction proposal on four phthalates in articles and on 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silanetriol and any of its mono-, di-, or tri-o-(alkyl) derivatives (TDFA) in sprays used by the general public. RAC and SEAC also agreed on 19 draft opinions on specific uses of chromium (VI) substances, 1,2-dichloroethane (EDC), and bis(2-methoxyethyl) ether (diglyme). The draft opinions will be sent to the applicants for comment before final adoption. RAC and SEAC completed their work on three further applications for authorization by adopting opinions on the industrial use of arsenic acid and chromium trioxide for the treatment of copper foil used in the manufacture of printed circuit board, and on the use of chromium trioxide in plating on plastics for automotive applications. More information is available in ECHA’s March 21, 2017, press release, “Restriction proposal on four phthalates and several authorisation applications agreed by RAC and SEAC.”
ECHA Adopts Final CoRAP For 2017-2019: ECHA announced on March 21, 2017, that it adopted the updated Community Rolling Action Plan (CoRAP) for 2017-2019. From the date of adoption, the Member States have 12 months to evaluate the 22 substances specified for 2017. If needed, the evaluating Member State will prepare a proposal for an ECHA decision to request further information from registrants to clarify the suspected risks. ECHA states that the substances were selected for substance evaluation to clarify the concerns related to their exposure and suspected serious hazard properties (persistent, bioaccumulative, and toxic (PBT), CMR, or endocrine disruptors in combination with wide dispersive consumer use). ECHA notes that other concerns may be identified during evaluation. ECHA encourages registrants of the listed substances to coordinate their actions and contact the evaluating Member State. ECHA urges registrants to communicate the up-to-date use and exposure scenarios of their substances. Registrants will have an opportunity to comment before any decision to request further information is taken. Such draft decisions will be reviewed by the other Member States and ECHA before the final decision is issued. ECHA notes that the number of substances to be evaluated in 2017 is lower than in previous plans and several evaluations have been postponed to 2018 and 2019. According to ECHA, this is to allow a compliance check to be done first to address possible gaps in standard information and to confirm that the substance is a priority for substance evaluation. Once the compliance check is concluded, the postponed substances will be reviewed to see if there are remaining concerns warranting substance evaluation. More information is available in ECHA’s March 21, 2017, press release, “Member States to evaluate 22 substances in 2017.”
ECHA Publishes Data On 15,000 Chemicals: ECHA announced on March 23, 2017, that it published on its website information on approximately 15,000 chemical substances registered under REACH. ECHA states that the information covers the intrinsic properties of each substance and the substances’ impact on human health and the environment. ECHA notes that the data come “directly from companies who make or import the substances and have registered them with ECHA.” In respect of the ownership rights of companies who submitted the data, the downloadable data includes only the results from studies conducted by companies, but not the full summary. In addition, the material does not include the data companies have claimed confidential in their registrations. ECHA suggests that researchers and regulators could use the data to develop new ways of determining the toxicity of chemicals, minimizing the need for animal testing. Companies can use the data to improve the way in which they use chemicals, for example, by improving their safety data sheets (SDS) and the classification and labeling of their substances and products. The data may be used only after agreeing to the terms and conditions, and not for registration under REACH. More information is available in ECHA’s March 23 2017, press release, “Data on 15 000 chemicals now available to use.”
ECHA Will Soon Send Information Requests On 27 Substance Evaluation Draft Decisions: On March 28, 2017, ECHA announced that beginning the last week of April 2017, it intends to send draft decisions on 27 substances to registrants. Registrants will have 30 days to review the draft decisions and submit comments. ECHA recommends that one representative, the registrants’ contact point, send consolidated comments on the draft decision on behalf of all addressed registrants of a substance. Registrants who have submitted a registration that is not yet completed in the submission pipeline will also receive the substance evaluation draft decisions for comments. In 2016, the Member States evaluated 39 substances listed in the CoRAP. In 27 cases, the Member States determined that further information was needed to assess the safety of the substance and prepared a draft decision to request this data. For 11 substances, the evaluating Member State concluded that no further data was needed. ECHA states that it will publish these conclusion documents on its website “in due course.” Currently, according to ECHA, no further actions are expected from the registrants of those substances. In one case, the evaluating Member State could not conclude the evaluation as key standard information related to substance identity was missing. ECHA states that consequently the substance evaluation is suspended and will resume once the necessary information is submitted. More information is available in ECHA’s March 28, 2017, press release, “Registrants should get ready to comment on 2016 substance evaluation draft decisions.”
EC Publishes European Council Statement And Q&A On UK Article 50 Notification: On March 29, 2017, the EC announced that the European Council received a letter from the British Prime Minister, Theresa May, notifying the United Kingdom’s (UK) intention to leave the EU. The notification follows the June 23, 2016, referendum and begins the withdrawal process under Article 50 of the Treaty. The announcement states: “We regret that the United Kingdom will leave the European Union, but we are ready for the process that we now will have to follow.” For the EU, the first step will be the adoption of guidelines for the negotiations by the European Council. These guidelines will set out the overall positions and principles in light of which the EU, represented by the EC, will negotiate with the UK.
The EC published questions and answers (Q&A) regarding the Article 50 notification. According to the Q&As, the negotiations will last approximately 18 months, from early June 2017 to October/November 2018. The EU Treaties will cease to apply to the UK from the date of entry into force of the agreement, or within two years of the notification of withdrawal if no agreement is reached. A country that has withdrawn from the EU may apply to re-join. It would be required to go through the accession procedure.
On April 5, 2017, the EP announced that an “overwhelming majority” adopted a resolution officially laying down the EP’s key principles and conditions for its approval of the UK’s withdrawal agreement. The EP notes that the UK remains an EU member until its official departure, and that this entails rights but also obligations, including financial commitments that may run beyond the withdrawal date. The resolution “warns against any trade-off between security and the future EU-UK economic relationship, opposes any sort of cherry picking or a piecemeal economic relationship based on sector-specific deals, and reiterates the indivisibility of the four freedoms of the single market — free movement of goods, capital, services, and people.” According to the resolution, only when “substantial progress” has been made in negotiations on how the UK is to leave can discussions begin on possible transitional arrangements. These arrangements must not last longer than three years, while an agreement on a future relationship can be concluded only after the UK has left the EU.
Both the European Chemical Industry Council (CEFIC) and the Chemical Industries Association (CIA) issued press releases on March 29, 2017. CEFIC “calls for certainty for continued EU-UK trade.” CEFIC urges both the EU and the UK “to take a pragmatic approach to negotiations.” According to CEFIC, manufacturers in the EU and UK have benefitted from the single market and open borders for decades. CIA “urges [an] ambitious approach to Brexit.” CIA states that “[o]ne of Britain’s top manufacturing exporters, the chemical and pharmaceutical industry, has urged the Prime Minister to secure a wide-ranging agreement as she kicks off the negotiations leading to the UK’s exit from the European Union.”
Stakeholders’ Day Presentations Available: ECHA’s April 4-5, 2017, Stakeholders’ Day conference offered registrants advice, guidance, and case studies to help them register successfully for the REACH 2018 deadline. The April 4, 2017, program featured a workshop, “From zero to registration,” presenting the REACH 2018 registration phases with new practical examples and key advice for each phase. Participants also got an overview of the Chemical Safety Assessment and Reporting tool, Chesar, and the new version of the Quantitative Structure-Activity Relationship (QSAR) Toolbox. The afternoon continued with training on IUCLID and the REACH-IT applications, used for preparing registrations. ECHA intended the training for anyone preparing to register for the REACH 2018 registration deadline. The April 5, 2017, program featured three main topics: REACH 2018 — one year to go; case studies for successful registration; and using chemicals safer in Europe. Presentations are available on ECHA’s website, and a video recording of both the plenary and training sessions will follow “shortly.”
ECHA Prompts Market Newcomers To Pre-Register: ECHA issued an April 5, 2017, press release to prompt companies that if they recently started to manufacture or import a non-CMR phase-in substance in amounts of 1 to 100 tonnes a year, they should pre-register it within six months after beginning the activity. The last opportunity is May 31, 2017. Pre-registration allows companies to continue supplying low-volume chemicals legally on the EU/European Economic Area (EEA) market until the May 31, 2018, REACH registration deadline. Companies that do not have a valid pre-registration or registration for their substances after May 31, 2017, will need to submit an inquiry to ECHA and register their substances before manufacture or import. ECHA states that preparing an inquiry with IUCLID will take more time than pre-registering through REACH-IT, will require more information, and will take more time for ECHA to process. ECHA cautions companies to consider this when planning access to market to avoid delays. Companies that manufacture or import a substance for research and development and make it available only to a limited group of customers may benefit from a specific Product and Process Orientated Research and Development (PPORD) exemption. In this case, they do not need to register or pre-register the substance. More information is available in ECHA’s April 5, 2017, press release, “Newcomer to the market? Act by 31 May to get one more year to prepare your registration.”
EC Begins Public Consultation On EU-OSHA And Three Sister Agencies: The EC announced on April 10, 2017, that it launched a public consultation in the context of the evaluation of the four EU agencies under the remit of Directorate-General (DG) Employment. The four agencies are:
The European Foundation for the Improvement of Living and Working Conditions (Eurofound);
The European Centre for the Development of Vocational Training (Cedefop);
The European Training Foundation (ETF); and
The European Agency for Safety and Health at Work (EU-OSHA).
The consultation process aims to collect information and opinions from the general public and stakeholders on the work of the agencies. The EC states that the public consultation aims at gathering new ideas for the future of the agencies, including governance issues and comparing alternative policy options. The consultation also seeks to assess the usefulness of the agencies with regards to relevance, effectiveness, efficiency, coherence, and added value. The EC states that it particularly seeks contributions from stakeholders of Eurofound, Cedefop, and EU-OSHA during the period 2011-2016. Comments are due July 5, 2017.