EU

BPC Considers Active Substances And Concludes On Union Authorizations For Disinfectants:

On March 5, 2019, the European Chemicals Agency (ECHA) issued a press release entitled “Biocidal Products Committee concludes on Union authorisations for disinfectants.” In its press release, ECHA provides that the Biocidal Products Committee (BPC) discussed three applications for the approval of active substances. The BPC concluded that carbendazim should not be approved for product-type 9 (i.e., fiber, leather, rubber, and polymerized materials preservatives). The BPC’s opinion is that carbendazim, which meets the exclusion criteria, cannot be approved for product-type 9 “because of unacceptable risks posed to the environment that cannot be mitigated.”

Regarding the two other active substances, the BPC requested the respective evaluating Member States to assess whether the active substances meet the new criteria for endocrine-disrupting properties before the BPC adopts its opinions. The active substances are:

• Azametiphos for product-type 18 (i.e., insecticides, acaricides, and products to control other arthropods); and

• Epsilon-metofluthrin for product-type 19 (i.e., repellents and attractants).

The BPC adopted “positive opinions” supporting Union Authorization for:

• Two applications concerning biocidal product families based on iodine/povidone-iodine in product-type 3 (i.e., veterinary hygiene disinfectants); and

• Three applications concerning biocidal product families based on propan-2-ol in product-type 2 (i.e., disinfectants and algaecides not intended for direct application to humans or animals) and product-type 4 (i.e., food and feed area disinfectants).

The BPC also adopted an opinion, addressing a request from the European Commission (EC), on a dispute between EU Member States in a simplified authorization procedure for a biocidal product. The EC, together with Member States, will take the final decisions on approval of the active substances and Union Authorization of the biocidal products.

Additional information is available in the Annex to ECHA’s press release.

ECHA Begins Public Consultation On Three Potential SVHCs: 

On March 13, 2019, ECHA began a public consultation on the following substances that have been proposed as substance of very high concern (SVHC):

Comments are due April 29, 2019.

Inspectors Checking Consumer Products For Hazardous Chemicals:

On March 13, 2019, ECHA issued a press release entitled “Inspectors checking consumer products for hazardous chemicals.” In its press release, ECHA indicates that inspections for two EU-wide enforcement projects are currently under way to identify hazardous chemicals in consumer products. One project focuses on treated articles and chemical mixtures for consumer and professional uses under the Biocidal Products Regulation (BPR). The other pilot project targets Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation and Classification, Labelling, and Packaging (CLP) regulation obligations for imported products, and is performed in cooperation with customs authorities.

The inspections under BPR-EN-FORCE-1 (BEF-1) started in January 2019, and will continue throughout the year. BEF-1 inspections are being carried out in 28 EU and European Economic Area (EEA) countries, and focus on treated articles for consumer and professional use. Inspected products include sports clothing and “products aimed for professional use such as building products, swimming pool equipment or personal safety equipment.” Chemical mixtures such as paints and inks are also covered in these inspections. Inspections under BEF-1 include a particular focus on illegal use of non-approved active substances and compliance with labeling obligations.

For the pilot project under REACH and CLP, inspections began in March 2019 and will continue until Autumn 2019. Inspectors and customs authorities in 16 participating EU Member States and EEA countries are working together to verify whether imported products comply with certain restrictions under REACH regarding hazardous chemicals (e.g., cadmium, nickel, and lead). Inspectors are also verifying that chemical products are labeled with the required safety information. If products are found to be non-compliant, “the import will be stopped and they will not be allowed to enter the EU market.” ECHA indicates that the “tighter collaboration” between inspectors and customs authorities will enhance further the protection of EU citizens from hazardous substances.

The final report for the pilot project under REACH and CLP is expected in mid-2020, and the results of BEF-1 will be published at the end of 2020.

SEAC Adopts Opinion To Restrict Hazardous Substances In Tattoo Inks: 

On March 14, 2019, ECHA issued a press release entitled “SEAC concludes to restrict hazardous substances in tattoo inks.” In its press release, ECHA provides that its Committee for Socio-economic Analysis (SEAC) adopted its final opinion supporting the proposal by Denmark, Italy, Norway, and ECHA to restrict the placing on the market of tattoo inks and permanent make-up including carcinogenic, mutagenic, and reprotoxic (CMR) substances, skin sensitizers and irritants, substances corrosive or damaging to the eye, metals, and “other substances regulated in cosmetic products.”

The restriction proposal includes concentration limits for the substances within its scope, and the aim of the restriction “is to make inks for tattooing safer and protect people from serious health problems or effects.” SEAC concluded that the proposed restriction is the most appropriate measure to control the risks posed by these substances, and that it is proportionate to the risk because it will bring significant benefits to society (i.e., avoid adverse skin effects and other health impacts), while not imposing significant economic impacts on supply chains. ECHA indicates that suppliers of tattoo inks may need to reformulate their inks within 12 months of the restriction entering into effect.

The opinions of the Risk Assessment Committee (RAC) and SEAC will be forwarded to the EC for preparation of a draft amendment to the REACH restriction list and the related “regulatory committee with scrutiny” process involving the European Parliament (EP), and possible amendment to Annex XVII of the REACH regulation. Additional information is available in ECHA’s Hot Topics Webpage for Tattoo Inks and Permanent Make-up.

ECHA PEG Reviewing Draft Appendix For Nanoforms Applicable To The Guidance On Registration And Substance Identification: 

ECHA has posted the draft version of a guidance document, Appendix for nanoforms applicable to the Guidance on Registration and substance identification. The draft guidance is being reviewed by a Partner Expert Group (PEG). The aim of the draft Appendix is to provide guidance on how to interpret the term “nanoform” for registration purposes and provide advice on how to create “sets of nanoforms” in a registration dossier. It also outlines what is expected in terms of characterization of the nanoforms and set of nanoforms in the registration dossier. Section 2 of the draft Appendix explains general requirements regarding the registration of nanoforms. Section 3 explains the concept of a nanoform, and how to distinguish a nanoform from another, and Section 4 focuses on how to create and justify sets of different nanoforms. As reported in our December 12, 2018, Global Regulatory Update, the EC amended several REACH Annexes to clarify the information requirements for nanomaterials. The information requirements will apply beginning January 1, 2020.

ECHA Publishes Updated CoRAP For 2019-2021: 

On March 19, 2019, ECHA announced that it adopted the updated the Community Rolling Action Plan (CoRAP) for substance evaluation, with 100 substances listed to be evaluated in 2019-2021. ECHA encourages registrants of listed substances to keep their registrations up to date and to contact the evaluating Member States. The updated CoRAP specifies 31 substances for evaluation in 2019, and the evaluating authorities have until March 2020 to carry out their evaluations. The aim of the evaluation is to clarify whether further information is needed to conclude whether a substance poses a risk to people or the environment. If necessary, registrants will be asked to provide this information. Authorities will assess the suspected concern and, where relevant, initiate regulatory risk management actions. More information is available in ECHA’s March 19, 2019, press release, “Member States will evaluate 31 substances in 2019.”

Enforcement-Related Activities To Focus On Evaluation Decisions, And Include Additional Reporting: 

On March 26, 2019, ECHA issued a press release entitled “Enforcement authorities to focus on evaluation decisions.” In its press release, ECHA refers to its earlier communication regarding dossier evaluation decisions under the REACH regulation, and indicates that the Forum for Exchange of Information on Enforcement (Enforcement Forum) and its BPR Subgroup met in Helsinki from March 19-22, 2019.

In its press release, ECHA states “[w]ith an increased focus on evaluation and an expected increase in the number of decisions, ECHA has invited enforcement authorities to [prioritize] the enforcement of evaluation decisions.” ECHA indicates that since January 1, 2019, when checking the compliance of REACH registration dossiers for substances it has been addressing its evaluation decisions to all registrants with non-compliant dossiers, in contrast to the “previous practice of mainly addressing lead registrants.” ECHA states that inspectors have effectively enforced its decisions since 2013, and that it “has now invited the enforcement authorities to [prioritize] the evaluation decisions in their enforcement activities.”

ECHA indicates that the Enforcement Forum agreed to start a “pilot to voluntarily report annual national enforcement activities” to ECHA. ECHA indicates that such reporting will support the planning and prioritization of the Enforcement Forum’s activities. Such annual reporting would be performed in addition to the mandatory reports that Member States submit to the EC every five years. After the pilot phase, the Enforcement Forum will decide whether the practice of annual reporting of enforcement-related activities will continue.

The Enforcement Forum’s BPR Subgroup agreed to work with the BPC to test whether national enforcement authorities can provide advice on the enforceability of risk mitigation measures that are proposed by the BPC for applications for approval of active substances and Union Authorization of biocidal products.

EC Holds Public Consultation For Continued Transitional Rules For Phase-In Substances Under REACH: 

The EC held a public consultation from March 26-April 23, 2019, on a Draft Implementing Regulation that proposes transitional rules for “phase-in” substances following the final REACH registration deadline. The Draft Implementing Regulation states:

In order to ensure equality between market operators manufacturing or placing on the market phase-in and non-phase-in substances, it is necessary to specify the applicability, after the expiry of the transitional regime, of provisions that laid down [favorable] conditions for the registration of phase-in substances. Therefore, for those provisions, an appropriate, reasonable and clear cut-off date should be set, after which those provisions should either no longer apply or only apply in specific circumstances. To take into account the definition of “per year” in Article 3(30) of [REACH] while also ensuring that market operators have enough time to adapt, it is appropriate to set the cut-off date at the end of this calendar year (31/12/2019).

The Draft Implementing Regulation indicates that REACH Article 3(30) sets conditions for the calculation of quantities per year for phase-in substances “based on the average production or import volumes for the three preceding years.” The Draft Regulation states “to ensure that market operators have sufficient time to make the necessary adjustments to their calculation methods, those conditions should, as a first measure, continue to apply until the specified cut-off date” (i.e., December 31, 2019). Article 1 of the Draft Implementing Regulation states that “the specific method” for calculating quantities per year of phase-in substances, as set out in REACH Article 3(30), shall apply until December 31, 2019. Article 1 also states “[o]nce a registrant has completed the registration of a substance, that registrant shall subsequently calculate his quantity of that substance per calendar year” in accordance with REACH Article 3(30).

The Draft Implementing Regulation indicates further that REACH Article 12(1)(b) provides less stringent information requirements for the registration of low volume phase-in substances. The Draft Regulation states that “[t]he deadline for registration of those low volume phase-in substances expired on 1 June 2018, but new toxicological and ecotoxicological information on substances in the lowest tonnage band between 1 and 10 [metric tons] should only be submitted for priority substances in that tonnage band ... In order to put Article 12(1)(b) efficiently into effect, that provision should, therefore, as a second measure, continue to apply after 1 June 2018.” In this regard, Article 2 of the Draft Implementing Regulation states “[t]he expiry of the transitional regime for phase-in [substances] in [REACH] shall not affect the applicability of Article 12(1)(b) of that Regulation.”

The Draft Implementing Regulation states that the formal operation of Substance Information Exchange Forums (SIEF) ceased on June 1, 2018. “As a third measure,” the Draft Implementing Regulation provides that the continuing data-sharing obligations of registrants should be reinforced and registrants should be encouraged to use similar informal communication platforms to “enable them to meet their continuing registration and data-sharing obligations under both [REACH] and Commission Implementing Regulation (EU) 2016/9.” Article 3 of the Draft Implementing Regulation states “[a]fter registering a substance, registrants, including those who jointly submit data with other registrants, shall continue to fulfil their data-sharing obligations in a fair, transparent and nondiscriminatory way as specified in Title III of [REACH] and in Implementing Regulation (EU) 2016/9. In that context, registrants may use informal communication platforms similar to the [SIEFs] referred to in Article 29 of [REACH].”

The Draft Implementing Regulation provides further that “[‌i]t is appropriate to set out, as a fourth measure,” that a potential registrant that pre-registered a phase-in substance in accordance with REACH Article 28 should, until the “specified cut-off date” (i.e., December 31, 2019), not be required to follow the inquiry process set out in REACH Article 26 “because the objective of the inquiry process has already been fulfilled through the pre-registration.” In this regard, Article 4 of the Draft Implementing Regulation states “[a]fter 31 December 2019, pre-registrations made in accordance with Article 28 of [REACH] shall no longer be valid and Articles 26 and 27 shall apply to all phase-in substances.”

The Draft Regulation states “[‌i]t is necessary to ensure that data-sharing dispute processes are clearly identifiable.” Therefore, the Draft Implementing Regulation provides that the data-sharing rules in REACH Article 30 should continue to apply until December 31, 2019. The Draft Regulation states “[a]fter that cut-off date, only the data-sharing rules in Articles 26 and 27 of [REACH] should apply.” Article 4 of the Draft Implementing Regulation states “[w]here data-sharing negotiations conducted in accordance with Article 30 of [REACH] result in failure to reach an agreement, the provisions of that Article shall apply only until 31 December 2019.”

The final version of the Draft Implementing Regulation will enter into force on the twentieth day following its publication in the Official Journal of the EU.

EP Approves Ban On Single-Use Plastic Items: 

On March 27, 2019, the EP voted in favor of an agreement with EU Ministers that will ban the following products in the EU by 2021:

• Single-use plastic cutlery (forks, knives, spoons and chopsticks);

• Single-use plastic plates;

• Plastic straws;

• Cotton bud sticks made of plastic;

• Plastic balloon sticks; and

• Oxo-degradable plastics and food containers and expanded polystyrene cups.

According to the EP’s March 27, 2019, press release, EU Member States will have to achieve a 90 percent collection target for plastic bottles by 2029, and plastic bottles will have to contain at least 25 percent of recycled content by 2025, and 30 percent by 2030. The press release states that the agreement “also strengthens the application of the polluter pays principle, in particular for tobacco, by introducing extended responsibility for producers. This new regime will also apply to fishing gear, to ensure that manufacturers, and not fishermen, bear the costs of collecting nets lost at sea.” The legislation stipulates that labeling on the negative environmental impact of throwing cigarettes with plastic filters in the street should be mandatory, as well as for products such as plastic cups, wet wipes, and sanitary napkins.

EC Issues 2018 Report On Safety Gate: 

On April 5, 2019, the EC issued a press release entitled “Protecting European consumers: toys and cars on top of the list of dangerous products.” In its press release, the EC indicates that it has released the “2018 report on the Safety Gate for dangerous products, the former Rapid Alert System.” The report shows that authorities exchanged 2,257 alerts on “dangerous products.” The EC indicates that toys belonged to the most notified category (31 percent), followed by motor vehicles (19 percent) and “clothing, textiles and fashion items” (10 percent). The EC states that the “main risks flagged” were chemical risks and injuries (25 percent each), followed by “the choking risk for children” (18 percent).

The EC’s report indicates that the following “highlights” are the main achievements of 2018:

• Highlight 1: A new Safety Gate that is user oriented;

• Highlight 2: A product safety commitment by four major online market places; and

• Highlight 3: Cooperation agreement with Canada.

The Safety Gate report provides that, in 2018, a series of alerts pointing at new squeezable or “squishy” toys have appeared in the system. The report states that most of the 23 alerts for “squishy toys” or “squeezable toys” reported that they contained “dangerous chemical substances such as N,N-dimethylformamide, N,N-dimethyl-aminoethanol, cyclohexanone and triethylenediamine, which pose a risk to the eyes, or cause mucous membrane irritation and liver damage.” The EC states that, in some cases, these toys may also pose risk of choking or suffocation, or microbiological risks, “all of which cause serious life-long health injuries, particularly to children.”

The EC states that more than half of all detected dangerous products come from China, and indicates that while cooperation with Chinese authorities in the product safety field continues to be a priority, “the results are mixed.” The EC indicates that it continues to work with the competent Chinese authorities on these matters, including “raising awareness about the product safety rules that need to be met when selling to EU consumers.”

Additional information is available in the EC’s “Questions and Answers on the Safety Gate for dangerous products.”

Report Maps Universe Of REACH-Registered Substances On The EU Market: 

ECHA released on April 17, 2019, the first report of the Integrated Regulatory Strategy, Mapping the chemical universe to address substances of concern. According to the report, the Integrated Regulatory Strategy aims to ensure the coherent implementation of the REACH and CLP processes and supports authorities in addressing substances of concern as soon as possible. The report notes that in May 2018, ECHA mapped the universe of all registered substances:

• Around 270 substances are of high priority for risk management;

• Around 1,300 substances are of high priority for data generation;

• Around 450 substances are considered of low priority as already sufficiently regulated; and

• Around 500 substances have been concluded to be currently of low priority after assessment.

ECHA is currently focused on the 4,700 substances registered above 100 tonnes. ECHA has already allocated more than 40 percent of these substances to the above categories of substances. According to the report, authorities still need to clarify in which category the remaining 2,700 substances belong, removing them from the “uncertain area.” ECHA foresees that a significant number of them will undergo compliance checks or substance evaluation in the coming years to generate the necessary information for priority setting and assessment. Lists of the substances belonging to the different categories are not included in the report. ECHA plans to publish them on its website at the end of 2019.

The report states that there is a need to speed up reviewing chemicals in the uncertain area and to shorten the time between identifying a concern and implementing the necessary regulatory risk management measures. To support this, ECHA states that it has moved from a substance-by-substance approach to the grouping of structurally similar substances. This grouping ensures the more effective use of all available information and enhances the coherence and consistency of authorities’ work when progressing with similar substances. This in turn supports informed substitution. To shorten the time between identifying a concern and regulatory action, EU Member States need to focus on initiating the regulatory processes. While experience has shown that authorities typically act quickly after good candidates for inclusion in the Candidate List or restriction are identified, there is clearly potential for initiating harmonization of classification or action under other legislation more swiftly. Where there are valid reasons for not moving forward with regulatory action, the report states that authorities should document these conclusions in a transparent manner so that full clarity on all higher tonnage substances in the chemical universe can soon be reached. More information is available in ECHA’s April 17, 2019, press release, “Registered substances mapped for regulatory action.”

ECHA Calls For Evidence Related To OELs For Diisocyanates And Lead And Its Compounds: 

On April 17, 2019, ECHA began calls for evidence on diisocyanates and lead and its compounds and their properties related to scientific evaluation of health-based exposure limits at the workplace. ECHA has been tasked by the EC with the scientific evaluation of occupational exposure limits (OEL), biological limit value(s), health surveillance measures, and/or appropriate notations for diisocyanates and lead and its compounds. The scientific evaluations of the health-based exposure limits are used to support the regulatory initiatives on OEL values for the protection of workers from chemical risks, to be set at the EU level pursuant to the Chemical Agents Directive (Directive 98/24/EC). ECHA states that the calls intend to gather information on uses, exposure, health effects, toxicology, epidemiology, and modes of action on diisocyanates and lead and its compounds. ECHA will use the information gathered to form the basis when drafting the scientific report. Evidence is due June 30, 2019.

EP Approves New Food Safety Rules Intended To Increase Consumer Trust: 

On April 17, 2019, the EP approved new rules intended to ensure that the EU’s risk assessment procedure for food safety is more reliable, transparent, and objective. According to the EP’s April 17, 2019, press release, the new rules will create a common European Database of commissioned studies to deter companies applying for authorization from withholding unfavorable studies. This will allow the European Food Safety Authority (EFSA) to make submitted studies public for third party scrutiny, which may be used to identify whether other relevant scientific data or studies exist, to ensure accuracy. To ensure the new rules are transparent, applicants must disclose all information relevant for assessing safety; some information, such as the manufacturing or production process, may be kept confidential, however. The new law also supports the implementation of a new pre-submission advisory procedure that enables EFSA to advise applicants on how to submit their application for authorization correctly, making the process more reliable. According to the press release, the new rules address concerns raised in the European Citizens’ Initiative on glyphosate regarding the transparency of the scientific studies used to evaluate pesticides. They also follow a fitness check of the General Food Law, launched in 2014 and completed in January 2018 by the EC. The Council of Ministers must formally approve the text before it can enter into force.

ECHA Will Hold Safer Chemicals Conference In May: 

On May 21-22, 2019, ECHA will hold a two-day conference on safer chemicals. ECHA states that the conference will offer stakeholders insight into the current priorities in EU chemicals regulation after the final REACH registration deadline. According to the program for May 21, 2019, the topic will be “Harmonised way to notify poison centres -- is your product ready?” On May 22, 2019, there will be three sessions: (1) “Improving compliance of registration data”; (2) “Tackling substances of concern”; and (3) “Improving safe use of chemicals.” Registration is full for May 21, 2019, but still open for the May 22, 2019, conference. ECHA will stream the conference on its website.

Second Meeting Of The Substitution And Innovation Network Will Be Held In May: 

On May 29, 2019, a workshop will be held to gather the network of stakeholders involved in supporting the substitution of hazardous substances and promote innovative and sustainable solutions. The workshop will aim to discuss and elaborate on mechanisms to support and expand on-going collaboration, capacity building, and adoption of substitution. The desired outcomes include:

• Review of actions implemented in 2018-2019 in the context of ECHA’s substitution strategy;

• Clarity on the follow-up actions and collaborations to sustain progress on support to substitution; and

• Identification of mechanisms needed to expand networking, collaboration and capacity building for an increased adoption of sustainable alternatives.

Registration closed on April 24, 2019.

INTERNATIONAL AGENCY FOR RESEARCH ON CANCER (IARC)

IARC Advisory Group Recommendations On Priorities For IARC Monographs Published: 

An Advisory Group of 29 scientists from 18 countries met on March 25-27, 2019, to recommend priorities for the IARC Monographs program during 2020-2024. The Advisory Group assessed the response to a public call for nominations and considered more than 170 unique candidate agents, including the recommended priorities remaining from a similar Advisory Group meeting convened in 2014. The Advisory Group deliberated on all nominated agents both by evidence stream (i.e., exposure, human cancer, cancer bioassay, and carcinogen mechanisms) and by type of agent (e.g., metals, fibers, chemicals, biological agents, and complex mixtures) to inform development of priority recommendations. The Advisory Group recommended a broad range of agents with high, medium, or low priority for evaluation. The Advisory Group assigned priority on the basis of evidence of human exposure and the extent of available evidence for evaluating carcinogenicity (i.e., the availability of relevant human cancer, experimental animal bioassay, or mechanistic evidence to support a new or updated evaluation according to the Preamble to the IARC Monographs). Agents without evidence of human exposure or evidence for evaluating carcinogenicity were not recommended for further consideration. The Advisory Group notes that it recognized that agents related to the identified priorities might also warrant evaluation. Furthermore, additional agents might merit consideration if new relevant evidence indicating an emerging carcinogenic hazard (e.g., from cancer epidemiology studies, cancer bioassays, or studies on key characteristics of carcinogens) becomes available in the next five years. IARC announced on April 18, 2019, that the recommendations were published in The Lancet Oncology, “Advisory Group recommendations on priorities for the IARC Monographs.” The Advisory Group recommended the following agents for evaluation with high priority:

* Advised to conduct in latter half of five-year period.

The complete list of agents recommended for evaluation with high, medium, and low priority is available in The Lancet Oncology. IARC will separately publish a detailed report of the Advisory Group.