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Top International News in Chemical Policy and Regulation: EU & UK

Bergeson & Campbell, P.C.’s much anticipated and highly acclaimed annual Forecast, “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018,” is now available. In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and The Acta Group (Acta®), B&C’s affiliated consulting firm, offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal, scientific, and regulatory issues expected to be hot topics in 2018. This 38-page document is chock-full of insights, predictions, and useful information.

EUROPEAN UNION (EU)

ECHA And EASA Sign Cooperation Agreement: On December 15, 2017, the European Chemicals Agency (ECHA) issued a press release entitled “ECHA and EASA signed an agreement of cooperation.” ECHA’s press release provides that ECHA and the European Aviation Safety Agency (EASA) will enhance further their cooperation, “[aiming] to ensure the best use of available resources by avoiding any duplication of efforts and overlapping activities.”

The cooperation between ECHA and EASA will focus on activities such as:

  • Exchange of information regarding authorization and restriction of chemicals as well as classification, labeling, and packaging of substances and mixtures when relevant for the activities of EASA;
     
  • Exchange of information regarding aspects of civil aviation as relevant for the activities of ECHA;
     
  • Participating in meetings in which the other party has an interest;
     
  • Implementing joint projects; and
     
  • Consulting one another on matters of common interest.

Further information is available in the “Memorandum of Cooperation” between ECHA and EASA.

Agreement Reached On EC’s Proposal To Modernize Waste Processing Rules: On December 18, 2017, the European Parliament (EP), the Council of the EU, and the European Commission (EC) reached an agreement on the EC’s 2015 circular economy package, consisting of four legislative proposals addressing waste, packaging waste, landfill, and electrical and electronic waste and an Action Plan. The proposed legislation will establish binding waste reduction targets and updated rules to decrease waste generation, ensure a better control of waste management, encourage the reuse of products, and improve recycling in all EU countries. According to the Council of the EU’s press release, the key elements of the agreed text include:

  • Clearer definitions of key waste concepts;
     
  • New binding targets at the EU level for waste reduction to be met by 20252030, and 2035. These targets cover the share of municipal waste and packaging waste recycling (with specific targets for various packaging materials), and also a target for municipal waste landfilled by 2035;
     
  • Stricter methods and rules to calculate the progress made towards those targets;
     
  • Stricter requirements for the separate collection of waste, reinforced implementation of the waste hierarchy through economic instruments, and additional measures for member states to prevent waste generation; and
     
  • Minimum requirements for extended producer responsibility schemes. Producers under these schemes are responsible for the collection of used goods, sorting, and treatment for their recycling. Producers will be required to pay a financial contribution for that purpose calculated on the basis of the treatment costs.

After formal approval, the proposed legislation will be submitted to the EP for a vote at first reading and to the Council for final adoption.

Registrants Of Certain Intermediates Will Receive Substance Evaluation Decisions: On December 19, 2017, ECHA announced that as of January 2018, it will send draft substance evaluation decisions to registrants of transported isolated intermediates. The change in practice follows a consultation of the EU Member States in November 2017. The change is intended to provide all registrants an equal possibility to comment on substance evaluation decisions. ECHA advises registrants to “speak with one voice” in the commenting phase. ECHA suggests that registrants of transported isolated intermediates may in the comments seek to demonstrate that the concern identified in the draft decision is not relevant to their specific strictly controlled conditions of use, as further substantiated. The evaluating Member State will take the comments into account. ECHA notes that the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation contains rules for the registration of intermediates (on-site isolated intermediates and transported isolated intermediates) and, under specific conditions, reduced information requirements may apply. ECHA states that on-site isolated intermediates under strictly controlled conditions are exempt from evaluation procedures, whereas transported isolated intermediates are not. Thus, transported isolated intermediate registration may be subject to an evaluation decision. More information is available in ECHA’s December 19, 2017, press release, “Registrants of certain intermediates to receive substance evaluation decisions.”

EC Tables Legislation Regarding Safe Products In The EU Single Market: The EC announced on December 19, 2017, that it tabled two legislative proposals intended to make it easier for companies, especially small- and medium-sized enterprises (SME), to sell their products across Europe and to strengthen controls by national authorities and customs officers to prevent unsafe products from being sold to European consumers. The EC states that the initiatives are designed to improve two aspects of the free flow of goods in the EU:

  • Making it easier to sell a product in another EU Member State: The mutual recognition principle is intended to ensure that products not subject to EU-wide regulation can move freely within the Single Market, if they are lawfully marketed in one Member State. In practice, companies wishing to sell products such as shoes, tableware, or furniture in another Member State often face barriers, delays, and extra costs. To make the principle faster, simpler, and clearer in practice, the EC proposes a new Regulation on the Mutual Recognition of Goods. Companies will know if their products can be sold in another EU country in a couple of months, rather than years. They will also be able to use a voluntary declaration to demonstrate that their products meet all the relevant requirements in their country. A problem resolution mechanism will allow for a faster resolution of disputes between companies and national authorities. Training and exchanges among officials will further improve collaboration and trust among national authorities.
     
  • Strengthen controls by national authorities to ensure that products are safe and comply with the rules: As many as 32 percent of toys, 58 percent of electronics, 47 percent of construction products, and 40 percent of personal protective equipment inspected do not meet the requirements for safety or consumer information foreseen in EU legislation. The draft Regulation on Compliance and Enforcement will help create a fairer internal market for goods through fostering more cooperation among national market surveillance authorities. This will include sharing information about illegal products and ongoing investigations so that authorities can take effective action against non-compliant products. The Regulation will also help national authorities to improve checks on products entering the EU market. Since 30 percent of goods in the EU are imported, the EC further proposes to reinforce inspections of ports and external borders.

The EC sent the draft Regulations to the EP and Council for adoption. Once adopted, they will be directly applicable.

DCG Recommends Actions Intended To Help SME Registrants: ECHA announced on December 20, 2017, that the Directors’ Contact Group (DCG) recommended four actions intended to ease the cost burden on first-time registrants for accessing data and the joint submission for their REACH 2018 registration:

  1. Reducing the costs of data for one to ten tonne registrants by exploring data waiving arguments;
     
  2. Addressing situations caused by late data-sharing negotiations or pending dispute decisions;
     
  3. Reducing the cost burden on SMEs by allowing payment in installments; and
     
  4. Offering a low-cost affordable lump sum payment option for one to ten tonne registrants.

ECHA notes that the DCG recommendations only concern access to existing data for registering substances by the May 2018 deadline. They will not apply to sharing the costs of creating new data or providing information, for example, in response to ECHA’s substance evaluation decision. More information is available in ECHA’s December 20, 2017, press release, “EU and industry directors recommend actions to help SME registrants.”

BPC Adopts First Opinions Supporting Union Authorization, And Several Other Opinions: On December 20, 2017, ECHA issued a press release entitled “First opinions on Union authorisation adopted.” In its press release, ECHA provides that the Biocidal Products Committee (BPC) adopted its first opinions supporting applications for Union Authorization for two products. The BPC also adopted opinions on six active substances for use in disinfectants, preservatives, and pest control.

Union Authorization applications were supported by the BPC for two product families containing iodine/PVP-iodine for use in veterinary hygiene. The BPC concluded the following on applications for active substances in disinfectants, preservatives, and pest control products:

  • Supported approval of cyphenothrin for product-type 18;
     
  • Supported approval of penflufen for product-type 8;
     
  • Supported approval of acetamiprid for product-type 18;
     
  • Cholecalciferol application for product-type 14 -- cholecalciferol can be considered as having endocrine-disrupting properties;
     
  • Proposed that formaldehyde is approved for product-type 2; and
     
  • Empenthrin may not be approved for product-type 18.

The BPC also adopted the following opinions, addressing requests from the EC:

  • For the first time, an opinion was given to support the EC in addressing an unresolved disagreement between Member States during the mutual recognition of insect repellent biocidal products.
     
  • The BPC concluded that copper sulphate does not act as an active substance in the product that was considered.
     
  • The BPC concluded that powdered corn cob is eligible for inclusion in Annex I (list of substances that do not give rise to concern).
     
  • Among the substances eligible for inclusion in the review program that benefitted from a derogation for food and feed (Article 6 of the Review Program Regulation), the BPC concluded that cheese, concentrated apple juice, d-fructose, honey, powdered egg, yeast (saccharomyces cerevisae), and vinegar are eligible for inclusion in Annex I.

The BPC’s adopted opinions will serve as a basis for final decision making by the EC and Member States. Additional information is available in the draft agenda for the BPC’s meeting.

ECHA Adds Seven Substances To Candidate List, Updates Entry For BPA: On January 15, 2018, ECHA announced that it added seven new substances of very high concern (SVHC) to the Candidate List and updated the entry for Bisphenol A (BPA). The BPA entry was updated to reflect an additional reason for inclusion due to its endocrine disrupting properties causing adverse effects to the environment. The substances included or updated and their SVHC properties include:

Substance name

CAS number

Reason for inclusion

Examples of use

4,4’-isopropylidenediphenol (bisphenol A; BPA)

80-05-7

Endocrine disrupting properties

Manufacture of polycarbonate, as a hardener for epoxy resins, as an anti-oxidant for processing polyvinyl chloride (PVC), and in thermal paper production

Chrysene

218-01-9

Carcinogenic

PBT

vPvB

Normally not produced intentionally but rather occurs as a constituent or impurity in other substances

Benz[a]anthracene

56-55-3

Carcinogenic

PBT

vPvB

Normally not produced intentionally but rather occurs as a constituent or impurity in other substances

Cadmium nitrate

10325-94-7

Carcinogenic

Mutagenic

Specific target organ toxicity after repeated exposure

Used for the manufacture of glass, porcelain, and ceramic products and in laboratory chemicals

Cadmium hydroxide

21041-95-2

Carcinogenic

Mutagenic

Specific target organ toxicity after repeated exposure

Used for the manufacture of electrical, electronic, and optical equipment and in laboratory chemicals

Cadmium carbonate

513-78-0

Carcinogenic

Mutagenic

Specific target organ toxicity after repeated exposure

Used as a pH regulator and in water treatment products, laboratory chemicals, cosmetics and personal care products

1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo [12.2.1.16,9.02,13.05,10] octadeca-7,15-diene (“Dechlorane Plus”TM) [covering any of its individual anti- and syn-isomers or any combination thereof]

--

vPvB

Used as a non-plasticizing flame retardant, used in adhesives and sealants and in binding agents

Reaction products of 1,3,4-thiadiazolidine-2,5- dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) [with ≥0.1% w/w 4-heptylphenol, branched and linear]

--

Endocrine disrupting properties

Used as a lubricant additive in lubricants and greases.

More information is available in ECHA’s January 15, 2018, press release, “Seven new substances added to the Candidate List, entry for bisphenol-A updated.”

EC Announces 2018 Circular Economy Package: In January 2018, the EC adopted a new set of measures as part of its continuous effort to transform Europe’s economy into a more sustainable one and to implement the ambitious Circular Economy Action Plan. The measures include:

  • A Europe-wide EU Strategy for Plastics in the Circular Economy and annex to transform the way plastics and plastic products are designed, produced, used, and recycled. By 2030, all plastics packaging should be recyclable. The Strategy highlights the need for specific measures, including a possible legislative instrument, to reduce the impact of single-use plastics. A public consultation is open until February 12, 2018. To reduce the leakage of plastics into the environment, the EC has adopted a new proposal on Port Reception Facilities to tackle sea-based marine litter and published a report on the impact of the use of oxo-degradable plastic, including oxo-degradable plastic carrier bags, on the environment.
     
  • A Communication on options to address the interface between chemical, product, and waste legislation that assesses how the rules on waste, products, and chemicals relate to each other. The Communication identifies four issues that constitute barriers for the circular economy:
     
    • Information on the presence of substances of concern is not readily available to those who handle waste and prepare it for recovery;
       
    • Waste may contain substances that are no longer allowed in new products;
       
    • The EU’s rules on end-of-waste are not fully harmonized, making it uncertain how waste becomes a new material and product; and
       
    • Rules to decide which wastes and chemicals are hazardous are not well aligned and this affects the uptake of secondary raw materials;
       
  • Monitoring Framework on progress towards a circular economy at EU and national level. It is composed of a set of ten key indicators that cover each phase -- i.e., production, consumption, waste management, and secondary raw materials -- as well as economic aspects -- investments and jobs -- and innovation.
     
  • Report on Critical Raw Materials and the circular economy that highlights the potential to make the use of the 27 critical materials in the EU’s economy more circular.

More information, including key documents in the 2018 circular economy package, is available on the EC’s website.

EP Political Leaders Approve Special Committee To Examine EU’s Authorization Process For Pesticides: The EP announced on January 18, 2018, that its political leaders have approved a special committee that will examine the EU’s authorization procedure for pesticides. The full House will make a final decision on the proposal at its February 5-8, 2018, session. According to the EP’s press release, the special committee “is a response to concerns raised about the risk posed by the herbicide substance glyphosate. The herbicide had its marketing license renewed by EU member states for five years in November last year.” The special committee would assess:

  • The authorization procedure for pesticides in the EU;
     
  • Potential failures in how substances are scientifically evaluated and approved;
     
  • The role of the EC in renewing the glyphosate license;
     
  • Possible conflicts of interest in the approval procedure; and
     
  • The role of EU agencies and whether they are adequately staffed and financed to fulfil their obligations.

More information is available in the EP’s press release, “Pesticides: Parliament to set up special committee.”

ECHA Shortlists 236 Substances For Possible Regulatory Action: On January 23, 2018, ECHA announced that it has selected 236 substances for further scrutiny by EU Member State competent authorities in its annual screening exercise. The competent authorities will carry out a manual examination of dossiers they prioritize to determine whether regulatory action is needed. According to ECHA, companies that registered a shortlisted substance will receive a letter informing them of the potential examination of the registration. ECHA encourages registrants to update their dossiers to address any shortcomings as soon as possible. ECHA based the selection mostly on an approach where it created groups around substances with suspected or known concerns, such as those on the Community Rolling Action Plan (CoRAP) for substance evaluation or on the Candidate List of SVHCs. ECHA selected substances to the groups based on read-across arguments and categories available in registration dossiers or categories used in other regulatory programs (e.g., the Organization for Economic Cooperation and Development (OECD)), as well as structural similarity. ECHA states that it does not make the list of shortlisted substances public “as it is based on automated selection and manual verification is needed to confirm a potential concern.” More information is available in ECHA’s January 23, 2018, press release, “236 substances shortlisted for possible regulatory action.”

ECHA Substitution Strategy Intended To Promote Use Of Safer Chemicals: ECHA announced on January 29, 2018, that its substitution strategy is intended to encourage the replacement of harmful chemicals by boosting the availability of safer alternatives and technologies. The substitution strategy highlights the following main areas of action for coordinated, EU-wide support of substitution:

  • Capacity building along the supply chain;
     
  • Funding and technical support for substitution initiatives;
     
  • Using ECHA’s chemicals data more efficiently; and
     
  • Developing coordination and collaboration networks.

ECHA states that implementation of the substitution strategy will form part of ECHA’s annual work plan, and learnings from supply chain collaboration workshops will help to develop further the strategy from 2019 onwards. ECHA will report annually its progress on the strategy’s implementation. ECHA notes that the strategy is linked to the EU priorities of a more circular and biobased economy, the sustainable manufacture and use of chemicals, and a non-toxic environment. More information is available in ECHA’s January 29, 2018, press release, “New strategy promotes substitution to safer chemicals in the EU.”

ECHA Offers To Help Registrants In Exceptional Cases: ECHA announced on January 31, 2018, that DCG has identified exceptional scenarios where registrants may, through no fault of their own, find it difficult to submit a complete registration dossier by the registration deadline. ECHA will help companies affected by the following four scenarios identified by DCG:

  • Completeness of dossiers: Companies that may have difficulties in providing data required in REACH Annexes VII and VIII in due time or importers of mixtures that have difficulties in getting compositional and analytical data of the substances in the mixture from their suppliers;
     
  • Legal entity change: Companies that do not hold a pre-registration due to legal entity changes;
     
  • Dependency on the lead registrant: If the lead registrant fails to submit a complete registration dossier on time, the member registrants may need exceptional support; and
     
  • Substance with no registration intentions: If no registration is planned for their critical substances, downstream users may consider taking up the role of an importer and submitting a registration, or engaging another importer to do so on their behalf.

ECHA states that every affected company will need to contact it as far ahead of the deadline as possible, and by May 24, 2018, at the latest. The registrant will need to provide detailed justification of its situation and an explanation of the measures that it has taken to comply with its obligations. More information is available in ECHA’s January 31, 2018, press release, “Helping registrants in exceptional cases.”

ECHA Holds Webinar On How Substances Are Shortlisted And Manually Screened: On February 1, 2018, ECHA held a webinar on how substances are shortlisted and manually screened. ECHA states that every January, a number of substances are marked for manual screening by EU Member States. The selection aims to identify substances that may have hazardous properties and the potential for exposure to humans or the environment. The webinar explained the screening process, ECHA’s timelines, and the criteria for shortlisting. The webinar also explained how registrants can influence the manual screening process by updating their dossiers and how they can get more information on common screening. The webinar provided advice on how registrants should react to informative letters sent by ECHA to all registrants of shortlisted substances. ECHA has posted the following webinar presentations:

UNITED KINGDOM (UK)

UK Publishes 25-Year Environment Plan, Will Develop Chemicals Strategy: The UK published on January 11, 2018, a report entitled A Green Future: Our 25 Year Plan to Improve the Environment. By adopting the Plan, the UK intends to achieve:

  • Clean air;
     
  • Clean and plentiful water;
     
  • Thriving plants and wildlife;
     
  • A reduced risk of harm from environmental hazards such as flooding and drought;
     
  • Using resources from nature more sustainably and efficiently; and
     
  • Enhanced beauty, heritage, and engagement with the natural environment.

The UK intends to manage pressures on the environment by:

  • Mitigating and adapting to climate change;
     
  • Minimizing waste;
     
  • Managing exposure to chemicals; and
     
  • Enhancing biosecurity.

The steps intended to increase resource efficiency and reduce pollution and waste include publishing a Chemicals Strategy that will “tackle chemicals of national concern” by building on existing approaches. The Plan states that the UK will take the following actions:

  • Publishing an overarching Chemicals Strategy to set out the UK’s approach as it leaves the EU;
     
  • Exploring options to consolidate monitoring and horizon-scanning work to develop an early warning system for identifying emerging chemical issues;
     
  • Considering how the UK will address tracking of chemicals in products to reduce barriers to recycling and reuse while preventing a risk from harmful chemicals; and
     
  • Working internationally to strengthen the standardization of methods that assess chemical safety in support of the mutual acceptance of data to identify and share information on emerging concerns and new approaches to risk assessments.

A spokesperson for the UK stated that the timetable for the Chemicals Strategy will be developed “in light of the progress of negotiations with the EU,” so that the strategy “can incorporate priorities for our domestic regulation and reflect our future relationship with the EU.”

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