Global Regulatory Update for October 2019
WEBINAR — Turkey REACH (KKDIK): Achieving Timely Compliance With New Chemicals Requirements, November 6, 2019, 12:00 p.m. – 1:00 p.m. EST: Turkey’s Registration, Evaluation, Authorization, and Restriction of Chemicals (Turkey REACH/KKDIK) regulation was issued by Turkey’s Ministry of Environment and Urbanization (MoEU) on June 23, 2017. The Acta Group (Acta®) and CRAD Çevre Risk Analiz Denetim A.S. are pleased to present the complimentary webinar “Turkey REACH (KKDIK): Achieving Timely Compliance with New Chemicals Requirements.” Entities manufacturing in or importing into Turkey chemical substances in quantities of one metric ton per annum or more are subject to pre-registration and registration processes under KKDIK with deadlines of December 31, 2020, and December 31, 2023, respectively. Register online.
WEBINAR — Value Chain Communications Required under TSCA Consent Orders and SNURs: How to Formulate Them and Optimize Their Value, November 13, 2019, 1:00 p.m. – 2:00 p.m. EST: The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) revised the new chemicals review process and existing chemicals risk evaluation scheme, resulting in increased requirements for chemical substance risk communication. Bergeson & Campbell, P.C. (B&C®) is pleased to present the complimentary webinar “Value Chain Communications Required under TSCA Consent Orders and SNURs: How to Formulate Them and Optimize Their Value.” This webinar outlines the categories of legally required risk communications to value chain participants required under TSCA Consent Orders and significant new use rules (SNUR) and will provide practical tips on how best to frame these risk communications to make them a valuable component of a company’s TSCA compliance and product stewardship program. Register online.
Lynn L. Bergeson, “The Growing Influence of Chemical Risk Evaluation on the M&A Market,” Financier Worldwide, October 2019: In 2018, the global M&A market achieved a transaction volume of $4.1 trillion, the third highest year ever for M&A volumes. This brisk pace is expected to continue. M&A activity demands razor-sharp due diligence. The premise of this article is that due diligence often underestimates or, worse, ignores the impact implementation of revisions to the Toxic Substances Control Act (TSCA), the U.S. industrial chemical safety law, has on commercial transactions. Implementation of these revisions is now influencing key sectors of the economy, making it essential that TSCA chemical risk evaluations be routinely included in M&A due diligence protocols.
Executive Branch Creates National Register of Chemical Precursors: The Executive Branch of the Argentine government has fulfilled its obligation under Law No. 23,737 and created the National Register of Chemical Precursors (NRCP). The NRCP, now found in Executive Branch Decree No. 593/2019, mandates that the Executive Branch shall “periodically prepare and update, by decree, lists of precursors, substances or chemical products that, by their characteristics or components, can serve as a basis or be used in the preparation of narcotic drugs.” Decree No. 593/2019 further directs that it will be the guiding document to regulate mixtures containing substances listed in the NRCP. Among the requirements for listed substances are reporting and restriction from use obligations.
The NRCP is contained in “ANNEXO II” of the document and is divided into “LISTA I” (41 items), “LISTA II” (14 items), and LISTA III (24 items). Notably, the substances set out in each of the three lists use the Mercado Común del Sur (Southern Common Market; MERCOSUR) Common Nomenclature (NCM), as opposed to a Chemical Abstracts Services Registry Number (CAS RN), to identify the substance(s). The NCM is the way in which merchandise is classified for customs and tax purposes in the trading bloc.
Chilean Authority Issues Draft Resolution on Pesticides: On September 3, 2019, the Chilean Servicio de Agrícola y Ganadero (Agriculture and Livestock Service; SAG) issued a draft resolution “Establece Procedimientos de Importación y Formulación Nacional de Plaguicidas de Uso Agrícola y Deroga Resolución Exenta del Servicio N°1038 de 2003” (Establishes Import Procedures and National Formulation of Agricultural Use Pesticides and Repeals SAG Exempt Resolution No. 1038 of 2003; Resolución). The Resolución sets out the procedures for the importation and the domestic development of agricultural use pesticides in the country. Simultaneously, the Resolución repeals the previous legislation in force, Exempt Resolution No. 1038 (2003).
Key among the provisions of the draft resolution are:
- Only those agricultural pesticides found on the Lista de Plaguicidas con Autorización Vigente (“List of Pesticides with Valid Authorization”; Lista) will be permitted to be imported and/or commercialized in the country;
- Each lot or item will be subjected to an inspection by SAG at the time of import, through a physical and documentary review, to establish its level of conformity with the information contained in the Lista; and
- La División de Protección Agrícola y Forestal (Protection Division, Agricultural and Forestry) will have the authority to sample (and to determine the percentage of samples taken) imported and domestically manufactured agricultural pesticides, to evaluate conformance with published quality specifications.
Section 2.1.1 of the Resolución is extensive in the requirements that an importer must present to SAG at the point of entry. As such, we have detailed them here:
- A Customs Destination Certificate (CDA), which must expressly indicate the authorization number given by SAG for each pesticide;
- A copy of the pesticide safety data sheet (SDS) in accordance with Law 18.164, in addition to any other information requested;
- An Agricultural Products Inspection Report (IIPA);
- An Original Certificate of Composition Analysis, a Composition Analysis Report, or a Certificate of Analysis with a digital signature, issued by the Manufacturer or Product Formulator, for each batch of pesticide. This document should state:
- Manufacturing Lot Number;
- Active ingredient and its concentration;
- Type of Formulation;
- Country of origin and pro forma invoice or document of similar probative value, in original or authorized copy, that indicates the volume of the item to be imported and its amount, in Cost, Insurance, and Freight (CIF) or Freight on Board (FOB) value; and
- Cargo manifest, bill of lading, or air waybill of the means of transport.
- Manufacturing Lot Number;
Comments are due by November 10, 2019. At present, there is no target date for final passage into national law.
China Issues Guideline For Environmental Risk Assessment Of Chemical Substances: On September 3, 2019, the Ministry of Ecology and Environment (MEE) and National Health Commission (NHC) jointly issued a final Technical Framework Guideline for Environmental Risk Assessment of Chemical Substances (Trial). This Trial Guideline provides a basic framework, including evaluation steps, technical requirements, and report preparation, for the environmental risk assessment of a single chemical substance under standard production and uses. The Trial Guideline does not apply to mixtures or exposures due to accidents or leakages. The “four-step” evaluation includes hazard identification, dose-response assessment, exposure assessment, and risk characterization. It also outlines uncertainty analysis, data quality assessment, spatial scale of exposure assessment, risk assessment of persistent, bioaccumulative, and toxic (PBT) and very persistent and very bioaccumulative (vPvB) chemical substances, and consideration for risk assessment of metals and their compounds. More information is available in The Acta Group’s (Acta®) September 13, 2019, memorandum, “China Issues Guideline for Environmental Risk Assessment of Chemical Substances.”
Ecuador Repeals Technical Regulation on Household Pesticides: The Ecuadorian Ministerio de Producción, Comercio Exterior, Inversión y Pesca (Ministry of Production, Foreign Trade, Investment and Fisheries) has notified the World Trade Organization (WTO) of its intent to repeal its January 23, 2017, Technical Regulation RTE INEN No. 258 Etiquetado de plaguicidas para uso doméstico (Labeling of Pesticides for Household Use). RTE INEN No. 258 had established the requirements for the labeling of “domestic use” pesticides, with an eye toward improving the health and safety of both users and the environment, as well as “avoiding the realization of practices that may lead to errors and cause confusion or deception to users,” for a specific set of Harmonized Tariff Classifications (HTC). Among these HTCs were insecticides and rodenticides, fungicides, herbicides, growth regulators and germination inhibitors, and disinfectants.
No effective date was given for the repeal, so it would appear to be immediate.
ECHA Holds Public Consultation On Applications For Authorization: The European Chemicals Agency (ECHA) has begun a public consultation on 27 applications for authorization covering 39 uses of:
- Chromium trioxide: Used in the manufacture of electrolytic chromium/chromium oxide coated steel;
- 4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated and 4-nonylphenol, branched and linear, ethoxylated: Used in the production of various medical devices (e.g., in vitro diagnostic kits) and medicinal products (e.g., active pharmaceutical ingredients); used in the production of chromatography resins for the biopharmaceutical industry, food and beverage sector, and academia;
- Pitch, coal tar, high-temp. and anthracene oil: Used in the manufacture of formulations mixtures for various industrial uses; and
- Pitch, coal tar, high-temp.: Used as a binder in the manufacture of clay targets.
More information about the uses for which authorization is sought, including the description of the function of the substance, exposure scenarios, possible alternatives identified by the applicants, together with socioeconomic information, is available on ECHA’s website. Comments were due October 9, 2019.
ECHA Publishes Information Requirements For Database On Articles Containing SVHCs: ECHA published a press release on September 9, 2019, regarding the new Substances of Concern in Articles, as Such or in Complex Objects (Products) (SCIP) database. Under the Waste Framework Directive, suppliers of articles containing substances of very high concern (SVHC) on the Candidate List must provide information on their safe use to ECHA. ECHA plans to release a prototype of the database in early 2020. It will be further improved and extended with new features later in 2020. Companies placing articles on the EU market will need to submit notifications beginning January 5, 2021. ECHA states that the aim is to promote the substitution of hazardous chemicals and a circular economy. ECHA developed the information requirements, which define the content of the database, based on legal requirements and consultations with the European Commission (EC), Member States, and stakeholders. Suppliers of articles must provide:
- Information that allows the article to be identified;
- The name, concentration range, and location of the SVHC in the article; and
- Possibly other information on the safe use of the article.
ECHA states that the SCIP database will provide waste operators with information about the hazardous substances in the waste they process so that material streams can potentially be “cleaned” before recycling and reused in the production of new articles to ensure a true and safe circular economy. According to ECHA, the increased transparency about the presence of hazardous substances will help consumers make better informed choices when purchasing products and provide information on how best to use and dispose of such articles. More information is available in ECHA’s September 9, 2019, press release, “SCIP database will improve transparency on hazardous substances in articles.”
NGOs Publish Report On Replacing Phthalates: The International Chemical Secretariat (ChemSec) published a press release announcing the availability of a report entitled Replacing Phthalates. ChemSec, ChemTrust, the Food Packaging Forum, and scientists from the University of Gothenburg and New York University formed part of a multi-year research project on hazardous chemicals in plastic packaging. According to ChemSec, the project identified phthalates “as one of the biggest culprits.” The report notes that in several cases, it has been proven that progressive chemicals policies drive innovation, and that “there is no reason why the case of phthalates should be any different.” More than stricter regulation is necessary to speed up the phase-out of hazardous phthalates. The report states that leading brands and companies “also need to be progressive and take the lead in the transition towards safer chemical alternatives.” According to the report, there are already viable safer alternatives on the market that can replace hazardous phthalates in many applications.
EC Consults On Draft REACH Regulation That Would Amend SDS Requirements”Under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, hazardous chemicals manufactured in the EU or imported must be accompanied by an SDS. On September 12, 2019, the EC began a public consultation on a draft regulation that would amend the SDS requirements. The draft regulation would:
- Align the data sheets with new United Nations (UN) requirements and requirements for nanomaterials; and
- Clarify certain aspects on information issued by poison centers.
Comments were due October 10, 2019.
ECHA Urges Companies To Prepare For “No Deal” Brexit: On September 12, 2019, ECHA issued a press release entitled “Act and prepare for ‘no deal Brexit’ to stay on the market and keep supplies.” In its press release, ECHA stated that it is “reminding companies that they need to prepare for a ‘no deal’ scenario ahead of the UK’s withdrawal from the EU, which is to take place on 31 October 2019 … As of 1 November 2019, the UK will be a ‘third country.’” ECHA urged downstream users located in the European Economic Area (EEA) to “act now” to avoid supply chain disruptions.
ECHA indicates that registrations completed by “UK manufacturers, importers and Only Representatives” will become void if they are not transferred to the EU Member States remaining after the United Kingdom’s (UK) withdrawal (EU-27)/EEA before the UK withdraws from the EU. ECHA provides that downstream users in the EEA can check the “List of substances registered only by UK companies” to “see if they will be affected and need to take action.” ECHA indicates that if such entities “plan to get their supply from the UK after the withdrawal, they should register the substance themselves as an importer, unless an Only Representative has been appointed for that registration in the EU-27/EEA.”
ECHA provides further that UK-based manufacturers and formulators that want to keep substances registered under REACH legally on the EU-27/EEA market can either transfer their business to, or appoint an Only Representative in, one of the EU-27/EEA countries. ECHA also refers in its press release to its guidance document entitled “How to transfer your UK REACH registrations prior to the UK withdrawal from the EU.”
EFSA Opens Consultation Period On Two Pilot Assessments On The Risks Caused By Multiple Pesticide Residues In Foods: On September 17, 2019, the European Food Safety Authority (EFSA) opened a consultation period on two pilot assessments of the risks posed to humans by residues of multiple pesticides in food. The first assessment considers the chronic effects of multiple pesticides on the thyroid system. The second looks at acute effects on the nervous system. In the two pilot assessments, EFSA classified pesticides into “cumulative assessment groups” based upon whether they produce similar toxic effects in a specific organ or system. EFSA states that “[t]he overall draft conclusion for both assessments is that consumer risk from dietary cumulative exposure is below the threshold that triggers regulatory action for all the population groups covered.” EFSA presented the assessments at a special stakeholder event in Brussels, Belgium, on October 22, 2019. The meeting allowed stakeholders with expertise and interest in the area to discuss the technical issues relating to the draft assessments. All comments must be submitted by November 15, 2019. In 2020, EFSA will prepare the assessments in final, which will serve to “inform risk managers in the European Commission and Member States who regulate the safe use of pesticides in the EU.”
SCBP Supports Postponements, Non-Approvals, And Union Authorizations: At its 65th meeting on September 19, 2019, the Standing Committee on Biocidal Products (SCBP) supported Commission Implementing Decisions to postpone the approval expiry date for the following product-type 8 substances:
- IPBC; and
A decision on postponement of the expiry date for the approval of propiconazole in product-type 8 was deferred to SCBP’s November 2019 meeting. SCBP also supported non-approval of the following active substances:
- Silver zeolite — product-types 2 and 7;
- Silver copper zeolite — product-types 2 and 7;
- Silver sodium hydrogen zirconium phosphate — product-types 2 and 7; and
- Carbendazim — product-type 9.
In addition, SCBP supported Implementing Regulations granting Union Authorization for: (1) the biocidal product family “Contec IPA Product Family”; (2) the biocidal product family “Pal IPA Product Family”; and (3) the single biocidal product “CVAS Disinfectant product based on Propan-2-ol.”
More Than 100 Signatories Commit To Use 10 Million Tons Of Recycled Plastic In New Products By 2025: The EC announced on September 19, 2019, that more than 100 public and private partners covering the entire plastics value chain will sign the declaration of the Circular Plastics Alliance. The declaration lays out how the alliance will reach the target of 10 million tons of recycled plastic used to make new products every year in Europe by 2025. The EC set this target in its 2018 Plastics Strategy as part of its efforts to boost plastics recycling in Europe. The declaration calls for a shift to zero plastic waste in nature and zero landfilling. It lays out concrete actions to reach the target, including:
- Improving the design of plastic products to make them more recyclable and integrate more recycled plastics;
- Identifying untapped potential for more plastic waste collection, sorting, and recycling across the EU, as well as the investment gaps;
- Building a research and development agenda for circular plastics; and
- Establishing a transparent and reliable monitoring system to track all flows of plastic waste in the EU.
On September 20, 2019, three NGOs — the European Environmental Citizens’ Organization for Standardization (ECOS), European Environmental Bureau (EEB), and Zero Waste Europe (ZWE) — issued a press release announcing that they will not sign the declaration “given the regrettable lack of ambition, transparency and NGO involvement.” The NGOs state that they “are particularly concerned by the complete omission of the risks associated with the presence of toxic substances in plastic waste: it should be ensured that hazardous chemicals do not make their way into new products through recycled content.” The NGOs criticize the emphasis that the declaration puts on investments in chemical recycling, a technology that they describe as “immature, with unanswered questions about costs and environmental impacts, and [that] should not be seen as a silver bullet to solve the plastic crisis.”
EUON Study Finds EU Regulatory Framework Ready For Next Generation Nanomaterials: On September 19, 2019, the EU Observatory for Nanomaterials (EUON) announced the results of a study it commissioned to examine “next generation” nanomaterials and determine whether the current terminology used in the EU chemicals regulations, as well as the implementation of the current legal requirements for identifying nanomaterials, are likely to pose technical challenges. According to EUON, the study findings “indicate that although the regulatory framework is well-equipped to handle these materials in the near future, further guidance would benefit companies registering nanomaterials” under REACH. The study recommends further clarifications for some parameters characterizing both nanomaterials and their uses and that the guidelines on how to determine whether an object is an article under REACH could be complemented with specific examples of different nanomaterials, from simple nanoparticles to more complex assembly structures.
Member States Unanimously Approve Increased Compliance Checks Under REACH: On September 20, 2019, the EC issued a press release entitled “Commission proposes to improve the compliance of chemical registration dossiers with EU law.” In its press release, the EC indicates that Member States in the REACH Committee agreed unanimously to an EC proposal amending the compliance check target for registration dossiers under REACH from 5 percent to 20 percent. The EC states that it can “proceed to adoption after a scrutiny period by the [European Parliament (EP)] and the Council of 3 months.”
The EC states that in approximately “1/3 of the dossiers checked by [ECHA],” information submitted by registrants did not meet REACH requirements. As a result, the EC indicates that it developed an Evaluation Action Plan with ECHA, “with the increase of dossiers checked for compliance as the first action.” The EC indicates that ECHA may examine any registration dossier to verify if the information submitted by registrants is compliant with legal requirements. The EC states that compliance checks evaluate substance identity description and safety information related to human health and the environment.
Under the new minimum target, ECHA aims to check 20 percent of dossiers for substances registered in very high volumes (i.e., more than 100 metric tons per year) by 2023, and 20 percent of dossiers for substances registered in lower volumes (i.e., 1-100 metric tons per year), covering approximately 30 percent of all registered substances by 2027. The EC provides that the “Evaluation Action Plan outlines the comprehensive strategy under which ECHA is screening all registration dossiers, proceeding directly with the development of further risk management measures where appropriate and launching compliance checks for those substances for which it considers that more information is needed.”
In conclusion to its press release, the EC indicates that companies need to review regularly registration dossiers and perform updates when necessary. The EC states it is “preparing an implementing regulation to further specify by which timelines the updates should be made.”
ECHA’s Committees Conclude On Two Restrictions And 15 Harmonized Classification And Labeling Opinions: On September 24, 2019, ECHA issued a press release entitled “ECHA’s committees conclude on two restrictions and 15 harmonised classification and labelling opinions.” In its press release, ECHA indicates that its Committee for Socio-economic Analysis (SEAC) adopted its final opinion on the restriction proposal by the Netherlands “to not place the granules and mulches in question on the market if the sum of the listed polycyclic aromatic hydrocarbons (PAHs) in the materials is more than 20 mg/kg.”
ECHA’s Committee for Risk Assessment (RAC) and SEAC supported the restriction proposal by Italy to restrict uses of N,N-dimethylformamide (DMF) on its own or in mixtures in a concentration equal to or greater than 0.3 percent. ECHA indicates that a public consultation “on the agreed SEAC opinion will begin soon” and that SEAC is expected to adopt an opinion at its December meeting.
RAC has adopted 15 opinions on harmonized classification and labeling, including opinions on 12 active substances used in biocidal products and/or plant protection products and three industrial chemicals. RAC agreed on five draft opinions on authorization applications for uses of chromium trioxide, coal tar pitch, high temperature and octylphenol ethoxylates. SEAC agreed on 18 draft opinions on uses of chromium (VI) substances, coal tar pitch, high temperature, and octyl- and nonylphenol ethoxylates. RAC and SEAC also discussed key issues in 27 applications for authorization, which were received by ECHA in May 2019. More information is available in the Annex to ECHA’s press release.
ECHA Proposes 18 Substances For Authorization: On October 1, 2019, ECHA issued a press release entitled “ECHA proposes 18 substances for authorisation.” In its press release, ECHA indicates that its ninth recommendation to the EC to prioritize SVHCs for authorization includes 18 substances:
|Substance Name||Examples of Uses in the Scope of Authorization|
(Bisphenol A; BPA)
|Epoxy resin hardeners|
|1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[22.214.171.124 .0 3.05,10]octadeca- 7,15-diene|
|Flame retardant in adhesives and polymers|
|Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde, and 4-heptylphenol, branched and linear (RP-HP)|
with ≥0.1% w/w 4-heptylphenol, branched and linear (4-Hbl)
|Lubricants and greases|
|Stabilizer in polymers|
|Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate|
(reaction mass of DOTE and MOTE)
|Stabilizer in polymers|
|4,4′-Bis(dimethylamino)-4?-(methylamino)trityl alcohol with ≥0.1% of Michler’s ketone (EC No. 202-027-5) or Michler’s base (EC No. 202-959-2)||Printing inks|
|Dioxobis(stearato)trilead||Stabilizer in polyvinyl chloride (PVC)|
|Fatty acids, C16-18, lead salts||Stabilizer in PVC|
|Trilead dioxide phosphonate||Stabilizer in PVC; rubber production; mirror backing|
|Sulfurous acid, lead salt, dibasic||(1)|
|Trilead bis(carbonate) dihydroxide||Artists’ paints|
|Lead oxide sulfate||Mirror backing|
|Cyclohexane-1,2-dicarboxylic anhydride ,|
cis-cyclohexane-1,2-dicarboxylic anhydride ,
trans-cyclohexane-1,2-dicarboxylic anhydride 
|Epoxy resin hardeners|
|Hexahydromethylphthalic anhydride ,|
Hexahydro-4-methylphthalic anhydride ,
Hexahydro-1-methylphthalic anhydride ,
Hexahydro-3-methylphthalic anhydride 
|Epoxy resin hardeners|
|Tetraethyllead||Additive in aviation fuel|
(1) The substance has no registered uses but is recommended based on grouping considerations as it could potentially replace other lead stabilizers in some of their uses. This is to avoid regrettable substitution.
ECHA provides that 13 of these substances are toxic for reproduction, of which one also has endocrine-disrupting properties. The other substances are an endocrine disruptor, a carcinogen, a vPvB substance, and two respiratory sensitizers.
ECHA indicates that the “substances have been prioritised from the Candidate List because of their intrinsic properties in combination with high volume and widespread uses, which may pose a threat to human health or the environment.” ECHA provides that some of the 18 substances are not currently used in the EU but could replace other substances recommended for the REACH Authorization List, and therefore an authorization requirement for such substances “should avoid regrettable substitution.”
ECHA organized a public consultation on the draft recommendation between September and December 2018. The Member State Committee (MSC) considered the comments received and adopted its opinion on June 26, 2019. ECHA considered the comments, registration updates, and the MSC’s opinion in deciding on the substances recommended for inclusion in the Authorization List, including the related latest application and sunset dates. All substances that underwent public consultation are included in the final recommendation.
The final decisions on inclusion of the substances in the Authorization List will be taken by the EC in collaboration with Member States and the EP. Further information, including details on the 18 substances, is available in the Annex to ECHA’s press release.
New Version Of EUSES Assists In Biocides Assessment: On October 1, 2019, ECHA issued a press release entitled “New version of EUSES tool helps companies assess biocides.” In its press release, ECHA indicates that the update of the EU System for the Evaluation of Substances (EUSES) revives a tool that has been available since the 1990s, but not maintained since 2012. ECHA indicates that the new version of EUSES will “help companies and authorities assess the environmental impact of biocidal active substances.”
ECHA provides that the new version of EUSES aims to address the immediate needs of companies and authorities performing environmental risk assessment for biocides. New and updated emission scenarios developed since 2012 for biocides have been added to the tool. ECHA indicates that EUSES users can assess active substances in 18 biocidal product-types. ECHA states that “[f]or two product-types – veterinary hygiene and insecticides – missing emission scenarios will be made available as separate tools on ECHA’s website.” The emission pathway of direct release to the environment has been included in EUSES throughout all the assessment steps.
ECHA indicates that a new version of the SimpleTreat model (4.0), which assesses the fate and distribution of a substance in a sewage treatment plant, has also been added in EUSES. ECHA states that the EUSES update focuses solely on biocides, and that for REACH, companies can also use the Chemical Safety Assessment and Reporting tool (Chesar). In the long term, ECHA indicates it is “looking to develop a central tool to harmonise chemical risk assessment for REACH and biocides.” Further information is available in ECHA’s guidance, “How to use EUSES 2.2.0.”
ECHA Calls For Evidence On Possible Restriction Of Lead In Shot, Bullets, And Fishing Tackle: ECHA announced on October 3, 2019, that it is investigating the need to restrict the use of lead in gunshot, bullets, and fishing tackle. The intention to prepare a restriction proposal has been added in the Registry of Intentions and is supported by a call for evidence and information. According to ECHA, the call is intended for companies; trade associations; hunting, fishing, or sports shooting organizations; scientific bodies; and any other stakeholders or Member States holding relevant information, including hunters and fishers and all others with an interest in this issue. ECHA is specifically looking for information on:
- The quantities of lead used or released to the environment and the resulting human health or environmental impacts;
- Current best practice to minimize lead exposure to humans or the environment during use;
- Alternatives to lead shot, bullets, and lead in fishing tackle; and
- Other socio-economic impacts on society with regard to a possible restriction, such as costs and/or benefits to any affected stakeholders.
ECHA held an online information session on October 10, 2019, to clarify the scope of its investigation and to respond to questions. Responses are due December 16, 2019. More information is available in ECHA’s October 3, 2019, press release, “Call for evidence on possible restriction of lead in shot, bullets and fishing tackle.”
ECHA Urges Companies To Get Ready For New REACH Requirements For Nanomaterials, Will Hold November Webinar: ECHA issued a press release on October 8, 2019, reminding companies that by January 1, 2020, companies must provide more information on nanomaterials on the EU market under REACH. The new information requirements concern companies that manufacture or import nanoforms of substances that are subject to registration under REACH. The EC amended several REACH Annexes to introduce clarifications and new provisions for:
- Characterization of nanoforms or sets of nanoforms covered by the registration (Annex VI);
- The chemical safety assessment (Annex I);
- Registration information requirements (Annexes III and VII-XI); and
- Downstream user obligations (Annex XII).
ECHA states that the purpose is to ensure that companies provide enough information to demonstrate the safe use of their nanoforms for human health and the environment. The amendments apply to all the new and existing registrations covering nanoforms. ECHA states that it expects registrants to update their existing dossiers with nanoform-specific information by January 1, 2020.
On November 12, 2019, ECHA will hold a webinar on the amended information requirements. The first part of the webinar will explain what a nanoform is and how to build a set of similar nanoforms. It will also explain how to fulfil data requirements for the characterization of nanoforms. The second part will introduce new International Uniform Chemical Information Database (IUCLID) fields for reporting the characterization parameters of nanoforms and give some practical examples on how to use the different fields. Attendees will also have the chance to ask questions from ECHA’s experts.
ECHA To Support Identifying New POPs: ECHA issued a press release, on October 9, 2019, entitled “ECHA to support identifying new POPs.” In its press release, ECHA indicates that it will support the EC and Member States to develop risk profiles for methoxychlor and Dechlorane Plus®. ECHA states “[t]his contributes to global work to eliminate or limit the use of the most hazardous [persistent organic pollutants (POP)].” ECHA provides that, in early October 2019, the Organic Pollutants Review Committee (POPRC) agreed that methoxychlor and Dechlorane Plus® fulfil the screening criteria as POPs. Together with the EC, ECHA will support POPRC in preparation of risk profiles for these substances and launch a public consultation on the drafts in early 2020.
If POPRC adopts the risk profiles, it will conduct risk management evaluations and then eventually recommend to list these substances as POPs in the Stockholm Convention. ECHA indicates that listing under this Convention would either result in worldwide elimination or strict restriction in production and use of the substances. Dechlorane Plus® is mainly used as a flame retardant and has been identified as an SVHC under REACH. Methoxychlor is a pesticide, and its “use in the EU has already been banned since 2002.” ECHA provides that both substances have adverse effects to humans and the environment.
In conclusion to its press release, ECHA indicates that, as of July 2019, it supports the EC and Member States to identify and propose new POPs from the EU to the Stockholm Convention.
Post-2018 Rules For REACH Registration Of Phase-In Substances Clarified: On October 10, 2019, ECHA issued a press release entitled “Rules for registration of phase-in substances clarified.” In its press release, ECHA indicates that the transitional regime for registering phase-in chemicals under REACH ended on May 31, 2018, and that the EC has now clarified that “certain provisions” for phase-in substances will continue to apply until December 31, 2019. ECHA indicates that the EC has set December 31, 2019, as the “cut-off date” after which “some conditions stipulated in REACH for phase-in substances will no longer apply.”
ECHA states “[c]ompanies need to pay attention to the clarifications made in the Implementing Regulation.” ECHA indicates that “[a]fter the cut-off date, companies will need to calculate their manufactured or imported volume per calendar year for each of their substances.” ECHA states further that, to enable registrants to continue with their data-sharing obligations, including for newcomers and updates of the registration dossier, the Implementing Regulation recommends that registrants should use “similar informal communication platforms to those used for registering phase-in substances.”
ECHA provides that, from the cut-off date, “companies that plan to register a substance will need to submit an inquiry to ECHA to get information on other registrants in order to begin data-sharing negotiations, and they can no longer rely on their pre-registrations.” ECHA states further that if data-sharing negotiations started within a Substance Information Exchange Forum (SIEF), “respective data-sharing disputes can be submitted according to Article 30(3) of REACH until the cut-off date.” ECHA indicates that after this date, “all data-sharing disputes will be handled according to Article 27.”
In conclusion to its press release, ECHA states that certain phase-in substances will continue to benefit from less stringent information requirements if they “are registered at the lowest tonnage band, between 1 and 10 tonnes per year and they do not meet the criteria listed in Annex III to REACH.”
EUON Seeks Topics To Address In Upcoming Studies: EUON announced on October 15, 2019, that it seeks topics that could be addressed in upcoming studies EUON states that it is looking for studies that address:
- Questions relating to the health and safety of nanomaterials, including hazard and risk assessment, exposure to nanomaterials, or worker safety and protection;
- Specific issues surrounding the uses of nanomaterials; or
- Information about markets for nanomaterials, focusing on EU markets.
According to EUON, the scope of the study can be on nanomaterials in general, a specific nanomaterial, or a defined group of nanomaterials. The study should be possible to execute within three to nine months. EUON notes that the studies “should be based on desk research and surveys and should not require laboratory research.” Proposals are due by January 15, 2020. The EUON secretariat will assess all proposals. Selected proposals will be carried out through EUON’s existing procurement channels. EUON will publish the outcome and study reports on its website.
ECHA Begins Public Consultations On Proposed OELs For Diisocyanates And Lead And Its Inorganic Compounds: On October 17, 2019, ECHA began public consultations on proposed occupational exposure limits (OEL) for diisocyanates and lead and its inorganic compounds. For diisocyanates, ECHA states that it has not proposed an OEL but recommends that RAC develop further the approach to derive an exposure response based on a weight-of-evidence assessment of three identified key documents presenting exposure responses for respiratory sensitization. When using the described exposure responses to establish an OEL (eight-hour time-weighted average (TWA)), ECHA states that a 15-minute short-term exposure limit (STEL) of not more than five times higher than the OEL value should be established. ECHA proposes skin sensitization, respiratory sensitization, and “skin” notations.
For lead and its inorganic compounds, ECHA recommends a biological limit value (BLV) of 150 micrograms (µg) lead per liter (Pb/L) in blood for inorganic and for organic lead compounds. To help achieve a blood-lead level below 150 micrograms per liter (µg/L), ECHA proposes to establish an OEL (eight-hour TWA) of 30 micrograms per cubic meter (µg/m3) for inorganic compounds and organic compounds (alkyl lead compounds). ECHA states that it does not seem possible to identify directly a maternal blood-lead level that would exclude the possibility of any effect on cognitive function development of the newborn. Therefore, ECHA recommends that RAC consider the following three options in their opinion development to address this effect:
- Option 1: A BLV of <50 µg/L is proposed for women of childbearing age;
- Option 2: The blood-lead level for women of childbearing age should not be higher than the reference values of the respective general populations not occupationally exposed to lead; or
- Option 3: It is recommended to make a qualitative statement in the Chemical Agents Directive that the exposure of fertile women to lead should be minimized or avoided in the workplace because the BLV for lead is not protective of the offspring of women of childbearing age.
Comments on the proposed OELs are due December 16, 2019.
OECD Publishes Report On Considerations When Assessing Children’s Exposure To Chemicals From Products: OECD published a September 6, 2019, report entitled Considerations When Assessing Children’s Exposure to Chemicals from Products that presents a children’s exposure decision tree intended to facilitate the inclusion of children’s exposure in risk assessments. According to the report, the decision tree can be used to determine if a separate exposure assessment is needed with regard to children and whether the exposure assessment conducted for adults already provides an acceptable level of safety for children. The report is focused on industrial chemicals in consumer products but notes that other types of products may also be covered as such definitions can differ between countries. Exposure via food or the environment is regarded as background exposure in the report. The report includes case studies on two types of hair spray, kitchen cleaner spray, and a pesticide in a public park.
OECD Holds Webinar On Finding Alternatives To PFAS: On September 26, 2019, OECD held a webinar on “Finding Alternatives to Per- and Polyfluoroalkyl Substances of Concern: A Difficult and Continuing Challenge” with the participation of W.L. Gore & Associates, Inc. OECD states that presenters shared efforts, successes, and challenges in eliminating per- and polyfluorinated chemicals of environmental concern from the life cycle of consumer products. The webinar included presentations by:
- Eeva Leinala, OECD Environment Directorate;
- Joe Carlin, leader of Gore’s Global Fluoromaterials Platform and Enterprise Fluoromaterials Stewardship Team; and
- Jon Hammerschmidt, the Sustainability Technical Champion for Gore’s Fabrics Division.
The webinar was held as part of OECD’s per- and polyfluoroalkyl substances (PFAS) webinar series, “bring[ing] world experts together to share vital information and best practices regarding PFASs.”
Defra Will Publish Chemicals Strategy Discussion Document By March 2020: The policy update paper for the September 2019 meeting of the UK Chemicals Stakeholder Forum notes that the UK government has committed to publishing a chemicals strategy. According to the update paper, the chemicals strategy will set out the “ambitious” approach of the Department for Environment, Food and Rural Affairs (Defra) toward ensuring the safe management of chemicals, its priorities for action, and details of how it will achieve its goals. Defra will publish a discussion document by March 2020 that incorporates a call for evidence. DEFRA intends to publish a final chemicals strategy by 2022. The process will include a formal consultation period. The next meeting of the UK Chemicals Stakeholder Forum will be held January 15, 2020.
CIA And Cefic Welcome Progress On Brexit: On October 17, 2019, the Chemical Industries Association (CIA) issued a press release entitled “Chemical sector cautious but relieved that progress has been made on Brexit.” In its press release, CIA states the chemical industry in the UK and Europe welcomes “the news that the negotiators have agreed on both a Brexit withdrawal agreement and future political declaration.” CIA states “[f]urthermore, we hope this can now be accepted by both Parliaments.”
Steve Elliott, Chief Executive of CIA, stated:
This deal — with its commitment to a free trade agreement avoiding tariffs and non-tariff barriers — represents an opportunity that we must now grab hold of, although we still seek reassurance that we can maintain a strong connection to the regulatory framework of our biggest and most important market … The deal will not be perfect for everyone including ourselves … It is now for MPs and MEPs to decide what happens next and in doing so, I hope they will take on board the points we have been making for the past three years.
Marco Mensink, Director General of the European Chemical Industry Council (Cefic), stated, “We are pleased to see the explicit reference to the exploring of ‘the possibility of cooperation of [UK] authorities with Union agencies such as [ECHA],’ which is something that we have been advocating for a long time as Cefic and CIA … We are looking forward to an orderly Brexit process that provides for a transition period followed by an ambitious (trade) agreement.”
UK Government Publishes Environment Bill: The UK government has published an Environment Bill that covers several important areas, including establishment of the Office for Environmental Protection (OEP), environmental targets and improvement plans, waste and resource efficiency, air quality and environmental recall, water quality, nature and biodiversity, and regulation of chemicals. The Bill seeks to support, among other goals, suitable environmental protection in the UK post-Brexit.
Regarding “[r]egulation of chemicals,” the Environment Bill indicates “Schedule 20 confers powers to amend the REACH Regulation and the REACH Enforcement Regulations 2008.” Schedule 20 provides that the Secretary of State “may by regulations amend the REACH Regulation” if it considers “that the provision made by the regulations is consistent with Article 1 of the REACH Regulation.” Schedule 20 provides further, subject to an exception, that the Secretary of State cannot make regulations which “amend any protected provision of the REACH Regulation.” Furthermore, Schedule 20 of the Environment Bill grants the Secretary of State authority to make amendments to the REACH Enforcement Regulations if “necessary or appropriate for, or in connection with, enforcement of the REACH Regulation.”
Schedule 20 of the Environment Bill indicates the following, among others, are “protected [provisions] of the REACH Regulation”:
- Article 1 (aim and scope of the REACH Regulation);
- Article 5 (the principle of “no data, no market”);
- Article 25(1) (animal testing as a last resort);
- Article 35 (access to information for workers);
- Article 45 (evaluation of substances on the rolling action plan);
- Article 48 (follow-up to substance evaluation);
- Article 92 or 93 (appeals);
- Article 54 (publication of information on evaluation); and
- Article 110 (relations with relevant public bodies).
The Environment Bill will be voted upon by UK Parliament prior to Royal Assent, and the timing for these measures is uncertain at this stage.