Global Regulatory Update for April 2019


WEBINAR -- Preserving Cosmetics On A Global Scale: It Is Harder Than You Think, May 22, 2019, 1:00 p.m. - 2:00 p.m. (EDT): Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to present the complimentary webinar “Preserving Cosmetics on a Global Scale: It is Harder than You Think.” The regulatory framework addressing what cosmetic product manufacturers must adhere to in incorporating preservatives in their products and what claims are permissible on product labels is far from harmonized globally, and the path is not getting easier. Join Karin F. Baron, MSPH, Senior Regulatory Consultant, Acta; Scott J. Burya, Ph.D., Regulatory Chemist, Acta; and Jane S. Vergnes, Ph.D., DABT®, Director of Toxicology, Acta, for an overview of cosmetic ingredient regulations in the U.S., the European Union (EU), Canada, and China, focusing on how preservatives are regulated in cosmetic formulations. A special focus will be on cosmetic claims specific to preservatives and how certain claims impact products’ regulatory jurisdictions. Register online now.

ARGENTINA

ANMAT Issues Cosmetics Safety Guidance: Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (National Drug, Food and Medical Technology Administration; ANMAT) has notified the World Trade Organization (WTO) of its intent to publish the Guía Referencial para la Evaluación de Seguridad de Productos Cosméticos, para la Higiene Personal y Perfumes (Reference Guide to Safety Assessment for Cosmetic and Personal Hygiene Products and Perfumes; Guía). The Guía contains general guidance geared toward assisting cosmetics sector entities in choosing appropriate safety design mechanisms for cosmetic and personal hygiene products and perfumes. Among the informational items contained in the Guía are guidance pertaining to the choice of ingredients, appropriate label design(s), and promotion of safe conditions of use. Entry into force was expected on March 22, 2019.

AUSTRALIA

Australia’s New Chemical Scheme Will Begin July 1, 2020; Early Regulatory Changes Now In Effect: The Industrial Chemicals Act 2019, which was passed by Parliament in February 2019 and received Royal Assent in March 2019, creates the Australian Industrial Chemicals Introduction Scheme (AICIS), a new regulatory scheme for the importation and manufacture of industrial chemicals in Australia. As of July 1, 2020, AICIS will replace the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). The ban on the use of new animal test data for ingredients solely used in cosmetics will also begin on July 1, 2020. The following early regulatory changes are now in effect under NICNAS:

  • No more annual reporting for permit holders and self-assessed assessment certificate holders;
     
  • Shorter timeframes for Approved Foreign Scheme assessments;
     
  • Polymers of low concerns are exempt from notification;
     
  • Expansion of the polymers of low concern criteria;
     
  • Changes to the definition of a new synthetic polymer; and
     
  • Safety data sheets (SDS) and labels are no longer required for cosmetics introduced at low volumes.
     

NICNAS is currently consulting on changes to the draft General Rules for the new scheme. The focus of the consultation is on amendments contained in the Industrial Chemicals Act 2019 that bring in new requirements for introducers. According to NICNAS, these requirements are that introducers will now need to make a one-off declaration for exempted introductions at the end of the registration year in which the introduction first occurs. In addition, during passage of the Act, the government agreed to explore how the General Rules could limit the use of new animal test data for introductions where the chemical has multiple end uses, including in cosmetics. Comments are due May 17, 2019.

BRAZIL

Brazilian Government Grants Approval To Highly Toxic Pesticides: The Ministro da Agricultura (Ministry of Agriculture) has issued approval notices for 40 pesticide-containing products, including sulfoxaflor, a systemic insect neurotoxin that is believed to affect vulnerable bee populations. Notably, some of the pesticide active ingredients granted approval by the Ministro in recent months are either extremely or highly toxic, such as methomyl and imazethapyr. The Coordenador Geral de Pesticidas (General Coordinator of Pesticides) has published a list containing in excess of 130 registration applications for pesticides, all of which were submitted during the final quarter of 2018. Registration applications may take up to five years to evaluate completely.

Comment Period For Glyphosate Uses Opened By Authority: Brazil’s Agência Nacional de Vigilância Sanitária (Brazilian Health Regulatory Agency; ANVISA) has opened its Draft Resolution No 613 (February 28, 2019) for public comment. Resolution No. 613 would maintain approval of glyphosate, a potent herbicide, but with new restrictions on its use. The central focus of the recommendation appears to be protection of agricultural workers and those who live near the fields.

Among the proposed recommendations are:

  • Banning oil/water emulsion formulations to reduce the possibility of inhalation or absorption exposure;
     
  • Establishing a rotating work schedule with respect to application activities (mixture, supply and application) so that no worker works in all of the phases, thereby minimizing exposure;
     
  • Increasing the Personal Protective Equipment (PPE) and keeping workers from re-entering treated areas;
     
  • Adopting technology to reduce the dispersion;
     
  • Establishing a safety zone of 10 meters at the application field when there are communities within 500 meters of the field;
     
  • Establishing a definition and criteria for exposure and tolerance limits for field workers;
     
  • Adjusting the tolerance limits for chronic exposure(s);
     
  • Defining a limit for acute exposure;
     
  • Banning the concentrated product for amateur gardeners; and
     
  • Prohibiting polyoxyethylene tallow amine (POEA) in concentrations over 20% in formulated products based on glyphosate.
     

Comments will be accepted until June 6, 2019.

CANADA

Canada Promulgates Environmental Emergency Regulations: On March 6, 2019, Canada published a Canada Gazette notice promulgating the Environmental Emergency Regulations, 2019, which are intended to reduce the frequency and severity of accidental releases of hazardous substances into the environment. The Regulations require that any person who owns or has the charge, management, or control of a regulated substance at or above certain quantities notify Environment and Climate Change Canada. For higher-risk facilities, an environmental emergency plan must also be prepared, brought into effect, and exercised. Schedule 1 of the final regulations includes 249 substances that pose an acute hazard to the environment or to human health should an accidental release occur. The Regulations will come into force on August 24, 2019.

Canada Publishes Information Received In Response To 2017 Inventory Update (Chemicals And Polymers): In April 2019, Canada published a summary of the results of its 2017 Inventory Update (chemicals and polymers). The Inventory Update surveyed substances on the Domestic Substances List (DSL), the Non-DSL, and the Revised In Commerce List. It considered substances identified by emerging science and domestic and international regulatory programs, as well as changes in Canadian commerce. According to Canada, the files provide an overview of the information gathered, including: type of submission; reported substances; substances that are manufactured or imported; industrial sectors involved; substance functions and commercial uses reported; and intended use (in commercial activity, in consumer activity, and by children). Canada states that it will use the information to update the commercial status of these substances, to inform priority setting, and to support risk assessment and risk management activities.

CHINA

China Seeks Suggested Amendments To Guidance On Catalog Of Hazardous Chemicals: The National Registration Center for Chemicals (NRCC) issued a notice on March 18, 2019, requesting comment on how to amend the Guidance for the Implementation of the Catalog of Hazardous Chemicals. In general, the almost 3,000 substances listed in the Catalog of Hazardous Chemicals are subject to Decree 591 and its subordinate regulations addressing their safe management throughout the supply chain. Listed substances need a license to be produced, used, or imported. The public comment period provides stakeholders an opportunity to comment on the classifications provided or request clarification on how to classify a chemical product. Comments are due April 30, 2019.

EU

Jason E. Johnston, M.S. Co-Authors “Benchmarking The Current Codex Alimentarius International Estimated Short-Term Intake Equations And The Proposed New Equations” In The Journal Of Agriculture And Food Chemistry: B&C and Acta are pleased to announce the publication of “Benchmarking the Current Codex Alimentarius International Estimated Short-Term Intake Equations and the Proposed New Equations,” co-authored by Jason E. Johnston, M.S., Senior Scientist with B&C and Acta. The article was published by the Journal of Agriculture and Food Chemistry and can be accessed at http://pubs.acs.org/doi/abs/10.1021/acs.jafc.8b05547. The five co-authors of the study were assembled by Cheryl Cleveland through CropLife America to react to a recent proposal to revise the International Estimated Short-Term Intake (IESTI) equations used in establishing Codex Maximum Residue Limits for pesticide residues on agricultural commodities. The authors conducted a series of dietary exposure assessments to benchmark exposures estimated using the existing and proposed IESTI equations against distributions of actual exposures. The authors of this study compared dietary exposures for pesticide residues in strawberries, tomatoes, and apples at five levels of refinement to place results from the IESTI equations into context relative to real-world exposures. The benchmarking exercise showed that the current IESTI equations are conservative predictors of dietary exposures, which suggests that there is no need to introduce further conservatism that would result from adoption of the proposed IESTI equations.

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):

Name Proposing Authority Reason for Proposing
2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides (covering any of their individual isomers and combinations thereof) Netherlands Equivalent level of concern having probable serious effects on the environment (Article 57f)

Equivalent level of concern having probable serious effects on human health (Article 57f)
2-methoxyethyl acetate Sweden Toxic for reproduction (Article 57c)
Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP) France Endocrine disrupting properties (Article 57(f) -- environment)

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:

  Rationale
Agents Not Previously Evaluated by IARC Monographs
Haloacetic acids (and other disinfection byproducts) Relevant human cancer, bioassay, and mechanistic evidence
Metalworking fluids Relevant human cancer and bioassay evidence
Cannabis smoking, fertility treatment, glucocorticoids, Salmonella typhi, sedentary behavior*, tetracyclines and other photosensitizing drugs Relevant human cancer and mechanistic evidence
Cupferron, gasoline oxygenated additives, gentian violet, glycidamide, malachite green and leucomalachite green, oxymetholone, pentabromodiphenyl ethers, vinclozolin Relevant bioassay and mechanistic evidence
Breast implants, dietary salt intake*, neonatal phototherapy*, poor oral hygiene* Relevant human cancer evidence
Aspartame Relevant bioassay evidence
Arecoline, carbon disulphide, electronic nicotine delivery systems and nicotine*, human cytomegalovirus, parabens Relevant mechanistic evidence
Agents Previously Evaluated by IARC Monographs
Automotive gasoline (leaded and unleaded), carbaryl, malaria New human cancer, bioassay, and mechanistic evidence to warrant re-evaluation of the classification
Acrylamide*, acrylonitrile, some anthracyclines, coal dust, combustion of biomass, domestic talc products, firefighting exposure, metallic nickel, some pyrethroids (i.e., permethrin, cypermethrin, deltamethrin) New human cancer and mechanistic evidence to warrant re-evaluation of the classification
Aniline, acrolein, methyl eugenol and isoeugenol*, multi-walled carbon nanotubes*, non-ionizing radiation (radiofrequency), some perfluorinated compounds (e.g., perfluorooctanoic acid) New bioassay and mechanistic evidence to warrant re-evaluation of the classification
Ostrogen:oestradiol and oestrogen-progestogens, hydrochlorothiazide, Merkel cell polyomavirus, perchloroethylene, very hot foods and beverages New human cancer evidence to warrant re-evaluation of the classification
1,1,1-trichloroethane, weapons-grade alloy (tungsten, nickel, and cobalt) New bioassay evidence to warrant re-evaluation of the classification
Acetaldehyde, bisphenol A*, cobalt and cobalt compounds, crotonaldehyde, cyclopeptide cyanotoxins, fumonisin B1, inorganic lead compounds, isoprene, o-anisidine New mechanistic evidence to warrant re-evaluation of the classification

* 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.

ISRAEL

Competent Authority Issues Revised Mandatory Standard Relating To Drain Cleaners: The Ministry of Industry, Trade and Labor (MOITAL) has revised Mandatory Standard SI 2250 Part 1, which addresses the safety, packaging and marketing requirements for domestic use drain cleaners. SI 2250 revises Israeli Mandatory Standard SI 2250 Part 1 from January 2008. The 2019 Standard adds a reference to Mandatory Standard SI 2301 Part 1 as part of the normative references in paragraph two, it removes paragraph four, which had previously dealt with the information required for marketing such substances, and removes Annex A. The new Standard will have a phase-in period of three years for the date of its passage into national law. During that three-year period, either the 2008 or 2019 Standard may be followed.

ORGANIZATION FOR ECONOMIC COOPERATION AND DEVELOPMENT (OECD)

OECD Will Hold Webinar On AOP Framework: OECD will hold a webinar on the adverse outcome pathway (AOP) framework on April 30, 2019. OECD describes the AOP framework as a collaborative tool that applies an innovative approach for collecting mechanistic knowledge from various sources that can eventually support chemical safety assessment. The webinar will address the following questions:

  • What is the AOP framework and why should you care?
     
  • Why are we developing AOPs?
     
  • Why collaborations are encouraged and why should scientific societies be brought in?
     
  • What are the opportunities for collaboration in AOP development?
     
  • How can your scientific achievements contribute to the overall knowledge?
     

Questions may be submitted in advance to ehs.contact@oecd.org by April 26, 2019. OECD states that submitting them in advance will help it determine the focus topics. Speakers will include:

  • Nathalie Delrue (OECD Secreteriat): OECD AOP Program;
     
  • Kate Willett (Humane Society International): An introduction to the AOP framework;
     
  • Jason O’Brien (Environment Canada): AOP collaborative development; and
     
  • Dan Villenueve (U.S. Environmental Protection Agency (EPA)): Examples of AOP application in chemical risk assessment.
     

SOUTH KOREA

Reminder On The Upcoming June 30, 2019, Registration Deadline For Existing Chemical Substances In South Korea: The South Korea amendment to the Act on Registration and Evaluation, etc of Chemical Substances (K-REACH) came into effect on January 1, 2019. All existing chemical substances (i.e., substances that are listed on the existing chemical inventory in South Korea) manufactured in or imported to South Korea at greater than or equal to one ton per year are now subject to registration.

Existing chemical substances must be pre-registered by the fast-approaching deadline of June 30, 2019. Pre-registered substances benefit from registration grace periods that allow existing chemical substances to be imported without full registrations.

Substance Type Registration Deadline
>1000 t/y existing substances
>1 t/y CMR substances
December 31, 2021
100-1000 t/y existing substances December 31, 2024
10-100 t/y existing substances December 31, 2027
1-10 t/y existing substances December 31, 2030

More information, including who needs to pre-register, how to determine the status of a chemical substance, what happens if pre-registration is not complete by the June 30, 2019, deadline, and the information needed to pre-register, is available in Acta’sApril 16, 2019, memorandum, “Reminder on the Upcoming June 30, 2019, Registration Deadline for Existing Chemical Substances in South Korea.”

TAIWAN

Taiwan EPA Amends Regulation Of New And Existing Chemical Substances Registration: On March 11, 2019, the Taiwan Environmental Protection Administration (Taiwan EPA) promulgated the amended Regulations of New and Existing Chemical Substances Registration. On April 18, 2019, Taiwan notified WTO that the regulations were promulgated on March 11, 2019, and came into effect on the same day. The WTO notification includes an English translation of the amended Regulations. For an existing chemical substance first manufactured or imported in an annual volume of 100 kilograms or more, a registrant shall, within six months from the date of occurrence of the fact, apply for the phase 1 registration and submit certain chemical information. No existing chemical substance may be manufactured or imported unless the registration approval is obtained within the specified time period. Appendix 6 of the English translation includes the designated list of 106 existing chemical substances subject to standard registration, the quantity thresholds, and the deadlines to complete the standard registration of the 106 chemical substances:

  1. For a phase 1 registration number first obtained before December 31, 2019, the registrant shall:
     
    1. Complete the standard registration before December 31, 2022, for substances tonnages at tonnages of one ton or more but less than 100 tons, based on the registered annual manufactured or imported volume at the time of obtaining the phase 1 registration number; or
       
    2. Complete the standard registration before December 31, 2021, for substances at tonnages of 100 tons or more, based on the registered annual manufactured or imported volume at the time of obtaining the phase 1 registration number.
       
  2. For a phase 1 registration number first obtained after January 1, 2020, the registrant shall, counting from January 1 of the following year upon obtaining the number:
     
    1. Complete the standard registration within three years, for substances at tonnages of one ton or more but less than 100 tons, based on the registered annual manufactured or imported volume at the time of obtaining the phase 1 registration number; or
       
    2. Complete the standard registration within two years, for substances at tonnages of 100 tons or more, based on the registered annual manufactured or imported volume at the time of obtaining the phase 1 registration number.
       
  3. For an existing chemical substance at annual tonnages of less than one ton when first obtaining the phase 1 registration number, the registrant shall:
     
    1. Complete the standard registration before December 31, 2022, for the substance’s actual manufactured or imported annual volume reaches one ton or more before December 31, 2019; or
       
    2. Complete the standard registration within three years, counting from January 1 of the following year, for the substance’s actual manufactured or imported annual volume reaches 1 ton or more after January 1, 2020.
       

TURKEY

Turkey Secures EU Funds To Support KKDIK Implementation: Turkey has obtained new funds from the EU to support implementation of KKDIK (Registration (Kaydı), Evaluation (Değerlendirilmesi), Authorization (İzni) and Restriction (Kısıtlanması) of Chemicals (Kimyasalların)) (Turkey REACH). Turkey has secured € 1.6 million as part of the Instrument for Pre-accession Assistance (IPA) program, “the means by which the EU supports reforms in the ‘enlargement countries’ with financial and technical help.” The funds obtained will be utilized by Turkey’s Ministry of Environment and Urbanization (MoEU) to upgrade the KKDIK-related IT platform in alignment with the EU system. This is an important measure for industry as we approach the KKDIK pre-registration and registration deadlines because there have been efficiency- and compatibility-related concerns regarding IT systems used under KKDIK. Turkey used an initial budget of € 2.5 million in developing KKDIK, and the recent EU funds obtained by Turkey are expected to assist MoEU in building capabilities for KKDIK activities. In addition to the IT upgrade, MoEU is expected to utilize the EU funds to provide KKDIK-related training programs for industry and its staff, and adapt into Turkish quantitative structure-activity relationship (QSAR) models.

The KKDIK capacity building and support activities will be performed as part of a two-year project, expected to start in 2019.

UNITED KINGDOM (UK)

DEFRA Issues Practical Guidance On UK REACH: On March 25, 2019, the Department for Environment, Food, and Rural Affairs (DEFRA) issued a guidance document entitled “‘Comply with UK REACH’: what you need to know about the IT system for UK REACH.” DEFRA’s guidance document provides that, in the event that the UK leaves the EU without a deal, the online service “Comply with UK REACH” will replace ECHA’s REACH-IT platform for UK REACH. The guidance document indicates that “[from] the day the UK leaves the EU,” entities will be able to use the online platform to:

  • Validate existing UK-held EU registrations (i.e., grandfathering);
     
  • Submit Downstream User Import Notifications (DUIN);
     
  • Submit new substance registrations; and
     
  • Submit new product- and process-orientated research and development (PPORD) notifications.
     

DEFRA provides further that communication will be required with the Health and Safety Executive (HSE), via e-mail, to ensure the following obligations are fulfilled:

  • Validation of existing UK-held PPORDs (i.e., grandfathering); and
     
  • Provision of information on “any [authorization] matter (including new [authorization] application, grandfathering of existing [authorizations], and downstream user notifications of [authorized] uses).”
     

DEFRA indicates that “[t]o be ready for using UK REACH, it’s a good idea to access your ECHA REACH-IT account and download all the information you hold there ... There is no guarantee that UK users will be able to retain access to ECHA REACH-IT once the UK leaves the EU and you will need your registration confirmation documents and ECHA decisions to comply with UK REACH.”

In a section of the guidance entitled “Your UK REACH account,” DEFRA indicates that “[o]nce the system is live, you will be able to sign in with a Government Gateway account if you already have one … If you don’t have one, you will be asked to create one.” The guidance document provides that each legal entity may only have one UK REACH account. DEFRA’s guidance indicates that Only Representatives (OR) will be able to create separate organization accounts to represent different clients. These accounts will be connected to ORs’ main legal entity accounts for UK REACH, and “[compartmentalized] to protect [ORs’] clients’ confidentiality.”

DEFRA’s guidance states “[‌i]f you are an existing EU REACH registration holder you will need to validate your EU REACH registration(s) within 120 days after exit, for them to continue to be legally [recognized] in the UK.” The guidance provides that, to validate EU REACH registrations under UK REACH, entities will “need to upload an IUCLID v.6 dossier on the UK REACH service.” The guidance document indicates further that “business rules checks are not required for initial information dossiers submitted when grandfathering within 120 days of exit.” DEFRA states “[y]ou will be issued with a UK REACH registration number … This number will be different from your EU REACH registration number.” DEFRA indicates that the grandfathering process will take approximately five minutes per substance, and will have to be repeated for each substance.

DEFRA indicates that the process for new substance registrations under UK REACH will resemble the equivalent process under EU REACH. In conclusion to the guidance document, DEFRA provides an e-mail address for submission of questions and indicates that a dedicated helpline telephone number will be established to address queries “[f]rom exit day” onwards.

Amendment To UK REACH And Explanatory Memorandum Published: The UK has made available an Amendment to the Draft UK REACH Statutory Instrument and an Explanatory Memorandum. The Explanatory Memorandum provides that, “[a]fter the [Draft UK REACH Statutory Instrument] was laid,” industry expressed concerns regarding the transitional import provision. Industry was concerned that, as drafted, the provision would lead to disruption in the supply chain for substances imported from outside the EEA. Industry was also concerned that the provision did not allow an OR to send “the required notification to the UK Agency.”

The Explanatory Memorandum states “[t]his instrument adds to the transitional import provision … The revised version will also apply to imports to the UK from outside of the EEA where an EEA-based [OR] had registered the substance under the EU REACH Regulation prior to exit ... It also inserts a new provision that allows UK-based [ORs] to provide the notification to the UK Agency.” The Explanatory Memorandum indicates, in the “Policy Background” section, that under the UK REACH transitional import notification system entities importing “[chemicals] will need to submit basic data on the company, substances and information on safe use within 180 days ... The interim notification will need to be replaced with a full registration after two years.”

The Explanatory Memorandum indicates that the transitional import provision in the UK REACH Statutory Instrument covers imports from “manufacturers or other producers in the EEA,” and also “covers the situation where a chemical is imported into the EEA under a registration held by an EEA-based [OR] and then sold on into the UK.” The Explanatory Memorandum states that the UK REACH Statutory Instrument “does not include the situation where a chemical was registered by an EEA-based [OR] but is imported directly into the UK from outside the EEA.” The Explanatory Memorandum provides that the revised text in the Amendment to the UK REACH Statutory Instrument “brings these importers within the scope of the transitional import provision.” The Explanatory Memorandum indicates that this “fulfils the intention that all chemicals registered under EU REACH should be able to access the UK market after exit through the transitional provisions.”

The Explanatory Memorandum provides that UK importers are “exempt from the duty to register that would otherwise lie with them” when covered by an OR’s registration for a substance, but the UK REACH Statutory Instrument “does not allow for a UK-based [OR] to carry out the transitional notification for the same chemical.” The Amendment to the UK REACH Statutory Instrument “reverses this so a UK-based [OR] can complete the notification, in which case the importer will be exempt from this duty.” The Explanatory Memorandum states this will reduce burdens on importers and “avoid unnecessary duplication” by importers and ORs. The Explanatory Memorandum states ORs will “also have easier access to better information about the chemicals, especially in the case of chemical mixtures or chemicals in articles ... This means that the regulator will receive better information, which will contribute to the intention of increasing the effective management of chemicals in the UK.”

The Amendment to the Draft UK REACH Statutory Instrument elaborates modifications to the UK’s draft post-Brexit REACH framework, including revisions to Article 127E and addition of Article 127EA, addressed above.

UNITED NATIONS (UN)

UNEP Releases Global Chemicals Outlook II: On March 12, 2019, the UN Environment Program (UNEP) announced the release of the Global Chemicals Outlook II: From Legacies to Innovative Solutions -- Implementing the 2030 Agenda for Sustainable Development. According to the report, countries will not meet the internationally agreed goal to minimize the adverse impacts of chemicals and waste by 2020, “meaning that urgent action is required to reduce further damage to human health and economies.” The report finds:

  • The size of the global chemical industry exceeded U.S.$5 trillion in 2017 and is projected to double by 2030;
     
  • The benefits of action to minimize the adverse impacts of chemicals have been estimated in the high tens of billions of U.S. dollars annually; and
     
  • International treaties and voluntary instruments have reduced the risks of some chemicals and wastes, but progress has been uneven and implementation gaps remain.
     

The report states that solutions exist, however:

  • Frontrunner companies -- from chemical producers to retailers -- are introducing sustainable supply chain management, full material disclosure, risk reduction beyond compliance, and human rights-based policies;
     
  • Consumer demand as well as green and sustainable chemistry education and innovation (e.g., though start-ups) are among the important drivers of change. They can be scaled up through enabling policies, reaping the potential benefits of chemistry innovations for sustainable development; and
     
  • Global knowledge gaps can be filled. This can be achieved, for example, by taking steps to harmonize research protocols, considering health or environmental impact information and harm caused to set priorities, and strengthening the science-policy interface through enhanced collaboration of scientists and decision-makers.

 
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