B&C Publishes 2021 Forecast: 2021 brings a new Administration to Washington, D.C., and Bergeson & Campbell, P.C.’s (B&C®) Forecast of the key chemical law and policy developments we are likely to see in 2021 is available now. The PDF version delivers 83 pages of detailed and helpful content regarding what to expect concerning regulatory programs and regions, including the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, the U.S. Food and Drug Administration (FDA), the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), the new United Kingdom (UK) REACH, Eurasia, Turkey, Asia, and more. B&C and The Acta Group (Acta®) professionals put in considerable effort to distill into this publication the key trends that will be important to clients, and we hope you find it helpful.
WEBINAR — What To Expect When You’re Electing (a New President), January 28, 2021, 1:00 p.m. EST: B&C is pleased to present “What To Expect When You’re Electing (a New President),” a webinar focusing on the incoming Biden Administration, including what policies and initiatives can be expected in the next four years and how any likely regulatory directions may affect our clients. Registration is now open.
ARTICLE — “M&A Activity In The Analytical Services Sector: Points To Consider,” Financier Worldwide, January 2021: There has been remarkable consolidation in the analytical services sector in the United States and elsewhere globally over the past few years and the need for analytical and related testing services is growing significantly. Because of the legal and regulatory frameworks that demand such services, however, there is considerable need for attendant technical expertise to staff these laboratories, and the need for specialized expertise is also growing exponentially. This article summarizes mergers and acquisitions (M&A) trends and explains why skilled help is essential to avoid liability.
Certain NICNAS Exemption Provisions Available Until August 31, 2022: Australia announced on December 17, 2020, that under the transitional arrangements, some exemption provisions that existed under the previous law, the Industrial Chemicals (Notification and Assessment) Act 1989, will be available to introducers until August 31, 2022. Introductions made under this arrangement are taken to be Australian Industrial Chemicals Introduction Scheme (AICIS) “reported introductions” under Section 27 of the Industrial Chemicals Act 2019 (current law). Australia states that this means that if the introduction meets the criteria for one of the exemption provisions that existed under the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), companies are authorized to introduce the chemical under AICIS as a “reported introduction” until August 31, 2022. Companies must keep records to prove that the chemical introduction meets the relevant exemption provision criteria. Australia notes that it may ask for these records to confirm that the chemical introductions are authorized.
SWA Will Resume Public Consultations On Workplace Exposure Standards: In March 2020, Safe Work Australia (SWA) paused the release and public consultation for the workplace exposure standards review until further notice. SWA will resume public feedback on February 1, 2021, with Release 15: Paraffin wax to Zirconium compounds. The comment period on Release 15 will be open until July 30, 2021. SWA stated in its January 18, 2021, e-mail that it is reviewing the workplace exposure standards for airborne contaminants to ensure they continue to be based on “high quality, contemporary evidence and supported by a rigorous scientific approach.” According to SWA, the review will result in the development of a list of health-based recommendations for the workplace exposure standards in Australia. This includes recommendations on the workplace exposure standards values, notations, and the list of chemicals.
Canada Publishes Results Of 2019 Identification Of Risk Assessment Priorities Activities: Health Canada (HC) and Environment and Climate Change Canada (ECCC) regularly review available information that could help inform the identification of substances of concern. On December 4, 2020, Canada published the results of the most recent review, Identification of Risk Assessment Priorities (IRAP) — Results of the 2019 Review, which consisted of identifying new information that would constitute indicators of hazard or exposure for the following types of substances:
- Substances on the Domestic Substances List (DSL) that have not been assessed within the past five years and are not scheduled to be assessed under the Chemicals Management Plan (CMP);
- Substances previously identified under IRAP and assigned an outcome of data gathering or international activity in previous review cycles where these data are now available; and
- Substances identified as potentially requiring review as a result of international assessment or management.
The review also included substances that were nominated as potential risk assessment candidates by HC or ECCC officials, based on knowledge acquired through research or expertise gained from previous assessments. Canada triaged approximately 16,000 substances identified as candidates to separate those that are unlikely to require further work based on information available at this time from those that represent potential new priorities for assessment, or if further information is required to make that determination. As a result of the evaluation, this IRAP review cycle identified 629 of the approximately 16,000 substances as having sufficient indicators of hazard or exposure to merit further activity, including: requiring further scoping/problem formulation (85 substances); additional data gathering (443 substances); or monitoring of ongoing international activity (101 substances). According to Canada, the remaining 15,629 substances do not require further action at this time.
Canada Proposes To Amend HPR To Align With Seventh Revised Edition Of The GHS: On December 19, 2020, the Department of Health published in the Canada Gazette a notice of its intent to amend the Hazardous Products Regulations (HPR). The HPR is the federal level legislation that sets forth the classification, labeling, and safety data sheet (SDS) requirements for hazardous products intended to be used, handled, or stored in workplaces in Canada. The HPR is based on the fifth revised edition (Rev 5) of the GHS. The proposed changes include updating the HPR to align with the seventh revised edition (Rev 7) of GHS. The transition period proposed is two years. The notice is open for comments for 70 days from the date of publication. More information is available in our January 14, 2021, memorandum, “Proposed Amendments to the Hazardous Products Regulations in Canada.”
China Publishes Final Notice On Convergence Matters Related To Transition From MEP Order No. 7 To MEE Order No. 12: The Chinese Ministry of Ecology and Environment (MEE), formerly the Ministry of Environmental Protection (MEP), released the final Notice on Convergence Matters Related to Environmental Management Registration of New Chemical Substances on October 27, 2020. Different from the draft Notice published in early June, new chemical substance registrations submitted and accepted by MEE before December 31, 2020, will be reviewed and approved under current MEP Order No. 7 until June 30, 2021. Registrations accepted under current MEP Order No. 7 that are not approved before June 30, 2021, will have to register according to MEE Order No. 12. The final Notice includes a six-month grace period for technical review and approval of new chemical substance registrations that have been submitted and accepted by MEE before December 31, 2020. More information on the Notice is available in Acta’s November 4, 2020, memorandum, “China Publishes Final Notice on Convergence Matters Related to Transition from MEP Order No. 7 to MEE Order No. 12.”
China Issues Final Guidance For Environmental Management Registration Of New Chemical Substances: MEE Order No. 12, “Measures on the Environmental Management Registration of New Chemical Substances,” replaced MEP Order No. 7, “Measures of Environmental Management of New Chemical Substances,” on January 1, 2021. To implement MEE Order No. 12, the MEE issued in final its “Guidance for Environmental Management Registration of New Chemical Substances” (Guidance) on November 17, 2020, which replaced the “Guidance for New Chemical Substances Notification and Registration” under MEP Order No. 7 on January 1, 2021. The final Guidance is generally the same as the draft Guidance that was reported in Acta’s August 20, 2020, memorandum, “China Publishes Draft Guidance for Environmental Management Registration of New Chemical Substances.” There are, however, some significant changes on confidential information protection and the data requirements for regular registration of new chemical substances with the potential for persistence (P) and/or bioaccumulation (B). More information is available in our November 23, 2020, memorandum, “China Issues Final Guidance for Environmental Management Registration of New Chemical Substances.”
EUROPEAN UNION (EU)
OiRA Offers Risk Assessment Tools For The Manufacturing Sector: On November 24, 2020, the European Agency for Safety and Health at Work (EU OSHA) published a news item announcing the availability of 15 risk management tools for the manufacturing sector. EU OSHA’s Online interactive Risk Assessment (OiRA) provides several tools to help businesses in the sector conduct occupational safety and health risk assessments as required by legislation. The tools address different subsectors such as printing, sewing, plastic, furniture, machinery, and drinks production, among others.
Pharmaceutical Strategy For Europe Will Include Revision Of Basic Pharmaceutical Legislation: On November 25, 2020, the European Commission (EC) announced the adoption of the Pharmaceutical Strategy for Europe, which is intended to ensure patients have access to innovative and affordable medicines and to support the competitiveness, innovative capacity, and sustainability of the EU’s pharmaceutical industry. Implementation of the Strategy will include legislative and non-legislative actions over the coming years. The EC states that actions “will cover the whole ecosystem of pharmaceuticals, but also some aspects of medical devices.” The Strategy creates synergies with the Green Deal and the EC’s actions under the EU Strategic approach of pharmaceuticals in the environment to reduce their environmental risk, address pollution from pharmaceutical residues, and promote greener manufacturing, use, and disposal. The flagship actions of the Strategy include:
- A revision of the basic pharmaceutical legislation (Directive 2001/83/EC and Regulation (EC) No 726/2004) (target date for the proposal is 2022) with a view to making the framework future-proof and innovation friendly;
- A proposal for an EU Health Emergency Response Authority (target date for the proposal is second semester 2021);
- A revision of the regulations on medicines for children and rare diseases;
- Initiating a structured dialogue with and between all actors in the pharmaceutical manufacturing and public authorities to identify vulnerabilities in the global supply chain of critical medicines and shape policy options to strengthen the continuity and security of supply in the EU;
- Cooperation between national authorities on pricing, payment, and procurement policies to improve the affordability and cost-effectiveness of medicines and health system’s sustainability;
- The creation of a robust digital infrastructure, including a proposal for a European Health Data Space (target date for the proposal is 2021);
- Support to research and innovation, notably via Horizon 2020 and EU4Health; and
- Actions to promote innovative approaches to EU research and development (R&D) and public procurement for antimicrobials and their alternatives and measures to restrict and optimize their use.
EC Publishes New Technical Guidance On Cosmetic Hand Gels That Addresses Antibacterial And Antiviral Claims: The EC announced on November 25, 2020, that it issued a new technical document that further clarifies which claims producers of cosmetic products cannot make regarding their products. According to the EC, the document adds to the Coronavirus crisis guidance, which informs economic operators on applicable regulations (i.e., the Cosmetic Products Regulation or the Biocidal Products Regulation (BPR)) and claims that can be made to the consumer. The EC states that several authorities signaled that there were leave-on hand gel cosmetic products on the EU market making ambiguous claims about their actual cosmetic or biocidal function. The new list provides full clarity on the claims that must not be used on cosmetic leave-on hand gels. These include claims such as “kills bacteria” or “sanitizing,” pictures or graphical elements related to coronavirus, and symbols of medical connotation such as a hospital red cross. The EC notes that EU economic operators and national competent authorities “can now refer to this list and implement the applicable legal framework in a more harmonised and coherent way.”
Ombudsman Issues Decision In Cases On How EC Approves Pesticides: The European Ombudsman issued a decision on November 30, 2020, in joint cases on how the EC approves substances used in plant protection products (pesticides). The Ombudsman examined the EC’s practice of approving active substances for which the European Food Safety Authority (EFSA) stated that it identified critical areas of concern or that it identified no safe use. The Ombudsman also revisited the EC’s practice of approving substances for which additional data confirming their safety is needed. The Ombudsman set out in detail why she considers that the EC’s current practices raise concerns. While the EC maintained that its practices comply with the applicable legal provisions, it informed the Ombudsman of several measures that should improve the approval process and increase its transparency. The Ombudsman closed the inquiry with three suggestions to the EC to ensure that it approves substances based only on uses that have been confirmed to be safe by EFSA, that the approval process is fully transparent, and that its use of the confirmatory data procedure is further restricted.
SEAC Concludes EU-Wide Restriction Best Way To Reduce Microplastic Pollution: ECHA announced on December 9, 2020, that its Committee for Socio-Economic Analysis (SEAC) “has adopted its opinion on a landmark restriction proposal, which would ban microplastics in products such as cosmetics, detergents, fertilisers and could lead to a ban of its use as soft infill on artificial turf sports pitches.” According to ECHA, the proposed restriction would prevent the release of 500,000 tonnes of microplastics into the environment over 20 years. The proposal aims to ban products from the European market that contain intentionally added microplastics if they are released to the environment when the products are used. Examples include cosmetics, cleaning and laundry products, fertilizers, plant protection products, and seed coatings. Other products, such as paints and inks, may contain microplastics, but ECHA notes that their use does not always lead to environmental releases. ECHA states that these uses are not proposed to be prohibited but would need to be reported to ensure that residual releases are monitored and could be controlled in the future. Suppliers would also be obligated to give instructions on how residual releases can be minimized. More information is available in ECHA’s press release, “Scientific committees: EU-wide restriction best way to reduce microplastic pollution.”
ECHA Reports That One Third Of Articles Claiming To Be Treated With Biocides Have Incorrect Labeling: On December 16, 2020, ECHA announced the results of the first coordinated enforcement project on biocides (BEF-1), run by the BPR Subgroup of the Enforcement Forum (BPRS). In 2019, national enforcement authorities in 22 member states inspected almost 1,200 companies and checked more than 1,800 treated articles, including clothing, paints, bedding, and chemical mixtures. According to ECHA, 73% of the treated articles were produced in the EU. In 36% of the cases, the quality of information provided on the labels of the treated articles was inadequate. For 42% of articles and 23% of mixtures, basic information, such as the name of the biocidal active substance used for treatment of the product, was missing. Inspectors also checked whether the biocidal products used to treat the articles contained active substances that were allowed in the EU. ECHA states that according to the self-declaration of the producers, “this duty was well fulfilled with less than 2.5 % of inspected products found to contain an illegal active substance.” The findings of the project “indicate that companies need to increase their knowledge about their responsibilities for treated articles and intensify their efforts to improve the overall quality of labelling, especially for articles treated with biocidal products.” More information is available in ECHA’s press release, “One-third of products claimed to be treated with biocides have incorrect labelling.”
Important Changes To Annex II To REACH Came Into Force January 1, 2021: As 2021 begins, new SDS requirements in the EU have entered into force. Commission Regulation (EU) 2020/878 of June 18, 2020, amends Annex II to REACH. The requirements for SDS layout and content appear in REACH, while the hazard classification criteria and labeling requirements are derivative of Regulation (EC) No 1272/2008 on the Classification, Labeling, and Packaging of Substances and Mixtures (CLP). The changes to the regulation applied starting January 1, 2021, with certain provisions in Article 2 that note that noncompliant SDSs may continue until December 31, 2022. Highlights of the major changes include:
- Addition of the unique formula identifiers (UFI) and nanoforms in Section 1;
- Inclusion of endocrine disruptors in Sections 2, 11, and 12;
- New considerations for the disclosure of ingredients in Section 3;
- Clarifications on content and order of details presented in Section 9;
- New subsections in Sections 11 and 12;
- Clarifications on maritime transport in Section 14 for bulk cargoes; and
- Specific provisions for authorizations and restrictions in Section 15.
A more detailed discussion on a few of the more significant changes is available in our December 16, 2020, memorandum. More information on the SDS requirements for nanoforms is available in our July 1, 2020, blog item.
ECHA Announces Receipt Of Five Million Notifications In SCIP Database: Beginning January 5, 2021, companies supplying articles containing substances of very high concern (SVHC) on the Candidate List in a concentration above 0.1% weight by weight (w/w) on the EU market must submit information on these articles to ECHA. The Substances of Concern In articles as such or in complex objects (Products) (SCIP) database is intended to ensure that the information on articles containing Candidate List substances is available throughout the whole life cycle of products and materials, including at the waste stage. Information in the database is then made available to waste operators and consumers. ECHA announced on January 11, 2021, that companies have already submitted more than five million notifications to the database. According to ECHA, its “IT systems are ready to continue receiving a large number of notifications.” ECHA intended to begin publishing the data on its website “in the coming months.” More information is available in ECHA’s press release, “SCIP duty kicks in: 5 million notifications received for harmful chemicals in products.”
ECHA Announces That Transfer Of UK Registrations To The EU Will Be Completed By End Of March 2021: On January 11, 2021, ECHA announced that of the 2,140 REACH registrants in the UK, 80% started or completed the transfer of their registrations to the EU by the end of the transition period on December 31, 2020. ECHA reminds successors that where the transfer has not yet been completed, they should accept the transfer “as soon as possible.” According to ECHA, if the transfer is not completed by March 31, 2021, “the transfer will be cancelled, and the registration revoked. This means that the registrants will no longer be able to legally place the substance on the EU market.” ECHA states that at least 2,900 UK registrations are now void and will be revoked as their transfer to the EU was not initiated by the end of 2020. As of December 31, 2020, 268 substances that were registered only by a UK-based company were not transferred to the EU, and ECHA states that the corresponding registrations will be revoked. ECHA notes that “[i]n terms of the potential market impact, it should be noted that about 60 % of these were registered only for intermediate use, meaning that they are used in the manufacture of other substances and transformed into them.” According to ECHA, registrations for 237 substances registered only in the UK are currently being transferred from the UK to the EU. More information is available in ECHA’s press release, “Transfer of UK registrations to the EU to be completed by end of March 2021.”
Two Chemicals That Are Toxic For Reproduction Added To Candidate List: ECHA announced on January 19, 2021, that the following two chemicals that are toxic for reproduction have been added to the Candidate List of SVHCs:
|Substance Name||Examples of Use(s)|
|Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety||Not registered under REACH as a group of substances. One of the three group members (dioctyltin dilaurate) is registered, however.|
The mono-constituent form of the substance (dioctyltin dilaurate) is used as an additive in the production of plastics and rubber tires.
ECHA states that companies must follow their legal obligations and ensure the safe use of these chemicals. From January 2021 onward, they also have to notify ECHA under the Waste Framework Directive if their products contain SVHCs. This notification is submitted to ECHA’s SCIP database, and the information will later be published on ECHA’s website.
ECHA Committee Approves Approach To Streamline Efficacy Assessment Of Disinfectant Product Families: ECHA announced on January 20, 2021, that its Biocidal Products Committee has agreed on a harmonized approach for determining products for worst-case testing when assessing the efficacy of disinfectant biocidal product families. ECHA states that the efficacy of all uses in a product family can be demonstrated with a so-called worst-case product, “usually a ‘member of the family’ that has the lowest concentrations of active substance and co-formulants that have a positive effect on efficacy, and highest concentrations of co-formulants that have a negative effect on efficacy.” The new document helps companies to identify the worst-case product composition and to design bridging studies for substantiating the choice of this composition.
New Zealand EPA Proposes To Update Hazard Classifications For Range Of Substances: On December 17, 2020, the New Zealand Environmental Protection Authority (New Zealand EPA) announced that it is proposing to update the hazard classifications for 123 substances, including single chemicals and mixtures, to take into account new information such as study data and reviews or assessments by overseas chemical regulators. New Zealand EPA states that substances containing the following chemicals are likely to be affected by the proposed changes: 1,3-dichloropropene; chlorpropham; flumetsulam; flumioxazin; 4-chloro-2-methylphenoxyacetic acid (MCPA) and its salts; metamitron; monensin and monensin sodium; narasin; pymetrozine; tea tree oil; thiodicarb; and trinexapac-ethyl. Changes to hazard classifications may result in changes to the controls that apply to the substances. New Zealand EPA recommends that suppliers, manufacturers, and users of chemical products check the application documents to see whether their products are affected by the proposed changes. Submissions on the chemical review are due February 26, 2021.
K-OSHA Amendments Effective January 16, 2021: Consideration for confidential business information (CBI) for hazardous substance ingredient disclosure on SDSs requires formal submission and approval in South Korea starting January 16, 2021. Hazardous substances requiring disclosure are those that meet the criteria defined in K-OSHA Enforcement Rule Article 141, which includes the Sixth Revised Edition (Rev. 6) of the GHS. In addition, any chemical substance chosen by the MoEL as causing harmful factors is subject to consideration, as stated in Article 104. Exemptions for the SDS submission include the following:
- Health functional foods, as defined in the Health Functional Foods Act;
- Source materials defined in the Act on Protective Action Guidelines against Radiation in the Natural Environment;
- Household chemical products subject to safety confirmation and biocidal products that are available for regular and/or daily consumer use as defined in the Act on Safety Management of Household Chemical Products and Biocides;
- Hygiene products as defined in the Hygiene Products Control Act;
- Medical devices as defined in the Medical Device Act;
- Other consumer use products, including products being used or handled in the workplace; and
- Chemical substances designated by the MoEL as used for Research and Development.
More information is available in our December 21, 2020, memorandum, “K-OSHA Amendments Effective January 16, 2021.”
UK REACH Began January 1: Beginning January 1, 2021, businesses that make, sell, or distribute chemicals into Great Britain (GB) must follow the UK’s new domestic chemicals regulations, including UK REACH. The UK announced on December 31, 2020, that the “Comply with UK REACH” system can be used by businesses to fulfil their transitional provisions and create new registrations. The new system enables the UK to make decisions on regulation of chemicals that are based on the best available scientific evidence, ensuring that chemicals remain safely used and managed. Businesses will be able to use the Comply with UK REACH IT service to:
- Validate existing GB-held EU registrations;
- Submit downstream user import notifications (DUIN);
- Submit new substance registrations; and
- Submit new product and process-oriented research and development (PPORD) notifications.
Businesses will need to contact the Health and Safety Executive (HSE) to ensure that they:
- Validate existing UK-held PPORDs; and
- Provide information on any authorization matter, including new authorization applications, grandfathering of existing authorizations, and downstream user notifications of authorized uses.
HSE Posts Webinar Recordings On Regulating Chemicals After The UK Transition Period: HSE has posted a series of videos on regulating chemicals after the transition period ended on December 31, 2020. The recordings include:
- HSE Chemicals REACH Registration, Evaluation, Authorisation and Restriction of chemicals update;
- HSE Chemicals CLP Classification, Labelling & Packaging update;
- HSE Chemicals PIC Prior Informed Consent update;
- HSE Chemicals BPR Biocidal Products Regulation update; and
- HSE Chemicals PPP Plant Protection Products update.
PPP Regulation After The Transition Period: Beginning January 1, 2021, HSE will operate a Plant Protection Products (PPP) active substance renewal program for GB that is independent of the EU. HSE will extend the expiration date three years for all active substances expiring before December 31, 2023. To support the renewal of approval in GB beyond the extended expiration date, HSE requires an application to confirm that the renewal of the active substance is being supported in GB. The application must be submitted three years before the extended approval expiration date. The PPP renewal guidance has been provided to detail the GB renewal application deadlines for active substances.
HSE will make use of assessments made in other jurisdictions where they are relevant and appropriate to GB. HSE will determine whether assessments are suitable for consideration by GB on a case-by-case basis. GB decisions will, at present, be made to the same regulatory standards as in the EU. Applicants can make a case as to why decisions from other jurisdictions may be valid. While other assessments (including those from the EU and other countries) could be used to support a GB application where they provide relevant information, HSE states that it will not rely wholly upon them and a different independent decision could be made in GB. Parallel permits will expire on December 31, 2022. The grace period allowed under Article 46 of EU Regulation (EC) No 1107/2009 will apply to parallel trade permits, meaning the distribution of products authorized under parallel trade permits can continue until June 30, 2023, with a further period of use up to June 30, 2024. HSE notes that if permits have an earlier expiration date, or if an earlier withdrawal decision is made, that will apply.
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