October 23, 2020

Volume X, Number 297

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ACTA Update March 5, 2020 - Top International News in Chemical Policy and Regulation

AUSTRALIA

Australia Consults On Draft Legislation For The National Standard For Environmental Risk Management Of Industrial Chemicals: 

Australia consulted on a draft legislative package for the National Standard for Environmental Risk Management of Industrial Chemicals (the National Standard). The National Standard has been developed by all Australian governments to manage efficiently and effectively the impacts of industrial chemicals on the environment, while providing consistent requirements for businesses across Australia. Australia states that the development of draft legislation for the National Standard builds on stakeholder consultation over a number of years and fulfils the shared commitment made by all Australian environment ministers. The draft legislative package includes:

Comments were due February 21, 2020.

NICNAS Revises Cosmetics Questionnaire: 

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced on January 28, 2020, that it revised the “Is my product a cosmetic?” questionnaire to make it easier to understand with more information to help companies. Based on four questions, NICNAS states that it will determine whether the product is a cosmetic. If it is a cosmetic, NICNAS regulates the ingredients. NICNAS states that it will provide instructions about how to import or manufacture (introduce) cosmetic ingredients legally and who to contact to find out other obligations for the product.

NICNAS Begins Public Consultation On Proposed Fees And Charges For AICIS: 

On January 31, 2020, NICNAS began a public consultation on proposed fees and charges for the Australian Industrial Chemicals Introduction Scheme (AICIS). The consultation paper notes that introducers of industrial chemicals will be subject to cost recovery fees and levies under AICIS beginning July 1, 2020. NICNAS seeks comment on the following questions:

  • What is the preferred option for calculating the registration levy from those proposed in Tables 6-9 of the consultation paper and for what reasons;

  • Now that fees and charges have been quantified in the consultation paper, what are the potential impacts of the proposed fees and charges on business;

  • Are there other economic conditions or changes to fees and charges payable to the Australian government that will have business impacts in addition to those arising from AICIS’s proposed fees and charges; and

  • Are changes in the frequency and type of interaction with the regulator over the next three years anticipated.

Comments are due March 13, 2020.

NICNAS Will Hold AICIS Education Workshops: NICNAS will hold information sessions in Sydney and Melbourne to help stakeholders understand and comply with AICIS, which starts on July 1, 2020. Topics covered will include transitioning from NICNAS to AICIS; categorizing chemical introductions; assessed introductions; evaluations; searching the Inventory and understanding listings; confidentiality of information; reporting and record keeping; compliance monitoring and enforcement; and use of animal test data. The workshop in Sydney is fully booked. Registration is open for a May 8, 2020, workshop in Melbourne and a May 1, 2020, workshop in Brisbane.

CANADA

Canada Publishes Hazardous Substance Assessments: 

In January 2020, Health Canada (HC) published hazardous substance assessments for the following five chemicals:

The hazardous substance assessments describe the classification of chemicals in the different hazard classes outlined in Schedule 2 of the Hazardous Products Act (HPA). HC notes that it has prepared the hazardous substance assessments as educational and information resources. Under the Hazardous Products Regulations (HPR), health hazards must be disclosed on the label of a hazardous product or the container in which the hazardous product is packaged and must be disclosed on the safety data sheet (SDS). According to HC, the hazardous substance assessments may be used by suppliers to meet these legislative requirements. HC states that suppliers are “ultimately responsible” for the accuracy of their hazardous product label and SDS.

Canada Publishes Draft Science Assessment Of Plastic Pollution: 

Canada published a Canada Gazette notice on February 1, 2020, announcing the availability of a draft science assessment of plastic pollution. The purpose of the report is to summarize the current state of the science regarding the potential impacts of plastic pollution on the environment and human health, as well as to guide future research and inform decision-making on plastic pollution in Canada. It provides a review of the available information on plastic pollution, including its sources, occurrence, and fate, as well as on the potential effects of plastics on the environment and human health. According to Canada, plastic packaging is the biggest contributor of plastic waste in Canada, followed by the automotive, textile, and electrical and electronic equipment sectors. Canada states that the report is not intended to quantify the risks of plastic pollution on the environment or human health, but rather to survey the existing state of science to guide future scientific and regulatory activities. Comments are due April 1, 2020.

EUROPEAN UNION (EU)

ECHA Assesses How To Make Tattoo Inks Safer: 

On January 21, 2020, the European Chemicals Agency (ECHA) issued a press release entitled “ECHA has assessed how to make tattoo inks safer.” In its press release, ECHA indicates that at the request of the European Commission (EC) it has assessed the safety of pigments used in tattoo inks. ECHA states that it “is not proposing to ban tattoos, nor all green and blue tattooing colours.” ECHA submitted its scientific opinions to the EC in June 2019.

Together with three Member States and Norway, ECHA has proposed to restrict over 4,000 substances in tattoo inks and permanent make up. Some of these substances are already “restricted under the EU’s Cosmetic Products Regulation and are not allowed to be used on the skin.” ECHA states “[t]hey are also, therefore, not safe to be injected under the skin either.” ECHA’s proposal includes “carcinogenic, mutagenic and reprotoxic (CMR) substances, skin sensitisers or irritants, substances corrosive or damaging to the eye, metals as well as other substances already regulated in cosmetic products.”

For Pigment Blue 15 and Pigment Green 7, “one option ECHA has recommended is that a two-year transitional period could be granted before banning them.” ECHA indicates this would allow ink formulators to find safer alternatives while ensuring the availability of green and blue tattoo inks in the meantime. ECHA’s restriction proposal has been subject to a consultation and scrutinized by its scientific committees. ECHA stated “[t]he Commission is presenting a draft restriction for discussion with EU Member States in February.”

NGO Report Claims That Economic Interests Dictate Restriction Proposals: 

On January 27, 2020, the International Chemical Secretariat (ChemSec) and the FRAM Center at the University of Gothenburg announced the results of a study entitled Political Economy of Listing of Substances of Very High Concern in the European REACH Regulation. According to ChemSec, the study shows that if EU Member States will lose money by regulating certain chemicals, these substances are less likely to be passed through to the legal bodies of the EU. Upon review of all chemicals proposed for the Candidate List, as well as who proposed them, ChemSec states that several things become obvious, “[t]he most glaring being that member states avoid proposing substances that play an important economic role within the country’s own borders.” In the cases where countries do propose chemicals that are produced nationally, ChemSec states that a majority are motivated by concerns for carcinogenicity and exposure to the general public. Moreover, 65 of the total 155 chemicals proposed by EU Member States “are not even produced or used in the EU (other than in such small amounts that it doesn’t require notifying authorities).”

ECHA To Verify Company Size Declarations: 

On January 31, 2020, ECHA issued a press release entitled “Is your company size declared correctly?” In its press release, ECHA indicates it “will soon verify the size of micro, small and medium-sized companies (SMEs) that have registered substances between 2016 and 2019 under [the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation] and benefitted from reduced fees.” ECHA states that SME registrants should check that the enterprise size claimed when registering or updating registrations is correct, and that the required support documents were uploaded to REACH-IT.

ECHA indicated in its press release that if the enterprise size claimed by companies “turns out to be incorrect,” they should inform ECHA “by sending an email to: sme-verification@echa.europa.eu by 11 February 2020 and update [information] in REACH-IT.” ECHA states “[b‌]y declaring and rectifying your size before ECHA begins the verification check, you will benefit from a full administrative charge waiver and only have to pay the difference to the applicable registration fee.” ECHA indicates that if it identifies during the verification process that entities have claimed an incorrect company size, they “will have to pay the balance of the accurate fee and an administrative charge of up to EUR 19 900.”

ECHA indicates that a stepwise approach on how to determine and declare the correct enterprise size is available on its website. In conclusion to its press release, ECHA emphasizes the importance of checking regularly REACH-IT accounts for “any messages and tasks from ECHA,” keeping contact details up to date, and reacting to ECHA’s requests.

Auditors Final Little Progress From EU Action On Pesticides: 

The European Court of Auditors (ECA) announced on February 5, 2020, that progress towards measuring and reducing risks from pesticide use in the EU has been limited. According to ECA, several EU Member States have been late in fully transposing the directive on sustainable use of pesticides, while incentives for farmers to adopt alternative methods remain weak. In addition, ECA states that the EC “is unable to precisely monitor the effects or risks resulting from pesticide use.” ECA acknowledged that since 2016, the EC has taken increased action to enforce implementation of the directive on sustainable use of pesticides. Integrated pest management (IPM) has been made mandatory for farmers, but according to ECA, there are no clear criteria or specific requirements to help ensure enforcement and assess compliance. While a category of “low-risk plant protection products” has been created, only 16 out of 487 substances, or three percent, have been made available for use to date, which ECA describes as “insufficient.” More information is available in ECA’s February 5, 2020, press release, “Little progress from EU action on pesticides.”

Standing Committee On Biocidal Products Supports Two Union Authorizations And One Extension: 

The Standing Committee on Biocidal Products has supported two draft regulations granting Union Authorizations for biocidal product families. The Committee supported Union Authorization for “SOPURCLEAN,” containing octanoic acid and decanoic acid as the active substances, in product-type 4. Further information regarding this measure is available in the Summary of Product Characteristics for a biocidal product family. The Standing Committee also supported Union Authorization for “HYPRED’s octanoic acid based products,” containing octanoic acid as the active substance, in product-type 4. Additional information is available in the Summary of Product Characteristics for a biocidal product family.

The Standing Committee supported the Swedish Chemicals Agency’s (KEMI) request to extend the market approval for Care Plus Mosquito Net, a mosquito net impregnated with the active substance permethrin. The mosquito net impregnated with permethrin is intended to provide protection of humans against stinging and biting insects, thus preventing the transmission to them of pathogens by insect vectors, which pose a risk to public health. An application for Union Authorization of Care Plus Mosquito Net is under evaluation, “but a significant amount of time is still needed to evaluate the application before the authorisation can be granted.” The draft Commission Implementing Decision states “[KEMI] may extend until 25 September 2021 the action to permit the making available on the market and use of the biocidal product Care Plus Mosquito Net to prevent the transmission of pathogens by insect vectors to humans, provided that the Agency ensures that the product is only made available and used under its supervision.”

Further information is available in the Standing Committee’s Agenda for its meeting on February 7, 2020.

Eleven Substances Added To REACH Authorization List: 

Commission Regulation (EU) 2020/171, published in the Official Journal of the EU on February 7, 2020, adds 11 new chemical substances to REACH Annex XIV, the Authorization List. Following addition of the 11 substances, REACH Annex XIV includes 54 substances in total.

The Regulation entered into force on February 27, 2020, adding the following substances to REACH Annex XIV:

  • 1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear -- Toxic for reproduction (category 1B);

  • Dihexyl phthalate -- Toxic for reproduction (category 1B);

  • 1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥0.3% of dihexyl phthalate -- Toxic for reproduction (category 1B);

  • Trixylyl phosphate -- Toxic for reproduction (category 1B);

  • Sodium perborate; perboric acid, sodium salt -- Toxic for reproduction (category 1B);

  • Sodium peroxometaborate -- Toxic for reproduction (category 1B);

  • 5-sec-Butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof] -- Very Persistent and Very Bioaccumulative (vPvB);

  • 2-(2H-Benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) -- Persistent, bioaccumulative, and toxic (PBT) and vPvB;

  • 2,4-Di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327) -- vPvB;

  • 2-(2H-Benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350) -- vPvB; and

  • 2-Benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) -- PBT and vPvB.

An ECHA report entitled Estimating the number and types of applications for 11 substances added to the Authorisation List in February 2020 states that ECHA expects to receive few applications for authorization for the 11 substances. According to market research conducted before the substances were added to the Authorization List, the only substance for which a potential applicant was found was trixylyl phosphate.

EC Seeks Comments On Proposed Changes To BPR Data Requirements: 

On February 13, 2020, the EC opened a public consultation on a Draft Regulation and Annex that propose amendments to data requirements under the Biocidal Products Regulation (BPR). The purpose of the proposed amendments is to adapt information requirements in BPR Annexes II and III in line with “scientific and technical progress in relation to the determination of endocrine-disrupting properties.” In addition, the Explanatory Memorandum to the Draft Regulation provides, the BPR Annexes should be adapted to “the current state of science, for example in relation to new test methods ensuring a better protection of human and animal health or reducing the number of tests conducted on vertebrate animals.”

The proposed amendments to BPR include:

  • Addition of a requirement for applicants to document “pre-submission consultations and their outcomes” and include the relevant documents in the application; and

  • A requirement for applicants to perform an extended one-generation reproductive toxicity study (EOGRTS) if there is no two-generation reproductive toxicity study (TGRTS) available.

The feedback period for the public consultation ends on March 12, 2020.

ECHA Launches Consultation On Potential Biocidal Candidate For Substitution: 

On February 14, 2020, ECHA launched a public consultation on the biocidal active substance Alpha-bromadiolone as a potential candidate for substitution. The evaluating Competent Authority for the substance is France, and the consultation concerns use of the substance in product-type 14 under BPR. The intended use of the substance includes application in and around buildings, in open areas, and in sewers by trained professionals, professionals, and the general public. ECHA’s public consultation page provides that Alpha-bromadiolone fulfills the substitution criteria under BPR Article 10(1)(a) and (e).

ECHA indicates that the public consultation gathers relevant information on the availability of substitutes or alternatives to the active substance. ECHA provides that information on the availability of possible alternatives “is highly important to support the comparative assessment that is required for the authorisation of biocidal products containing the active substance (considered as a candidate for substitution).” Information submitted as part of the public consultation may be non-confidential or confidential. A justification is required for submission of confidential information, and any information claimed confidential will be available only to members of the Biocidal Products Committee (BPC), the Member State competent authorities, and the BPC Secretariat in ECHA. At the end of the public consultation period, BPC will “take into account the confidential and non-confidential information received before finalising its opinion.”

The public consultation for Alpha-bromadiolone ends on April 14, 2020.

ECHA Launches SCIP Prototype: 

On February 17, 2020, ECHA issued a press release entitled “Towards circular economy: test our database to track harmful chemicals in products.” In its press release, ECHA indicates that companies can now start to test its Substances of Concern in Articles as such or in Complex Objects (SCIP) database of products containing Candidate List substances. ECHA indicates that the final SCIP database, established under the Waste Framework Directive, will be launched later in 2020. Companies will need to submit information to the SCIP database from January 2021 onward.

ECHA indicates that the SCIP Prototype allows “companies to get familiar with the database and test how to submit their SCIP notifications.” ECHA indicates that users can submit test data and provide feedback to ECHA to assist in improving the final version of the SCIP database. ECHA states that all submitted test data will be deleted before the launch of the final version. Bjorn Hansen, ECHA’s Executive Director, stated:

Tracking harmful chemicals is the key for moving towards a more sustainable circular economy. All materials are made of chemicals and we need to make sure we know which products contain harmful chemicals before they are recycled. Our upcoming database will help us to make products safer.

As of January 5, 2021, companies placing articles on the EU market will need to submit SCIP notifications to ECHA if the articles “contain substances of very high concern (SVHCs) in concentrations above 0.1 % weight by weight.” Companies will need to submit: (1) information to identify the article; (2) the name, concentration range, and location of the SVHC in the article; and (3) other information on safe use. Companies will be able to submit data in late 2020 when the final database is launched. ECHA provides that the aim of the SCIP database “is to promote the substitution of hazardous chemicals and transition towards a safer circular economy.”

EC Carries Out Early Review For Approval Of Three Biocidal Active Substances: 

The EC has started an early review for the approvals of the following biocidal active substances:

  • Iodine;

  • Polyvinyl-pyrrolidone (PVP) iodine; and

  • Zineb.

The EC states “[b‌]efore a biocidal active substance can be approved by the Commission, its safety for human health, animal health and the environment as well as its effectiveness against harmful organisms are evaluated. … The Commission may review the approval of a biocidal active substance for one or more product-types at any time where there are significant indications that the conditions laid down in Article 4(1) of [BPR] are no longer met.”

The EC indicates that BPR Article 5(1) provides that active substances considered as having endocrine-disrupting properties “that may cause adverse effects in humans, or which are identified in accordance with Articles 57(f) and 59(l) of Regulation (EC) No 1907/2006” as having endocrine-disrupting properties, shall not be approved “unless the conditions for derogation set out in Article 5(2) are met.”

The EC provides that the scientific criteria for determining endocrine-disrupting properties under BPR have been applicable since June 7, 2018, and states that it “has significant indications that the active substances iodine, PVP iodine and zineb may have [endocrine-disrupting] properties.” Consequently, the EC states, these substances may no longer satisfy the conditions laid down in BPR Article 4(1) or, where applicable, the conditions set out in BPR Article 5(2). As a result, the EC “has decided to review the approval of these substances.”

EC Publishes 14th ATP To CLP: 

On February 18, 2020, the EC published the 14th Adaptation to Technical Progress (ATP) to the Classification, Labeling, and Packaging (CLP) regulation in the Official Journal of the European Union. The delegated regulation makes the following changes in Table 3 of Annex VI:

  • Deletion of two entries;

  • Changes to 12 existing entries; and

  • Addition of 17 entries.

The substances newly added to Table 3 include titanium dioxide, which has been classified as a suspected human carcinogen (i.e., carc. 2) in powder form containing one percent or more of particles with aerodynamic diameter ≤10 micrometers (μm). The 14th ATP also amends Annexes II (Special Rules for Labeling and Packaging of Certain Substances and Mixtures) and III (List of Hazard Statements) to support new labeling obligations for mixtures containing titanium dioxide. The harmonized classifications in the 14th ATP will apply beginning September 9, 2021.

While the EU Council of Ministers adopted an early “non-objection” decision, the European Parliament (EP) extended the deadline to February 4, 2020, after the European Conservatives and Reformists (ECR) tabled an objection to the proposal to classify titanium dioxide as a suspected carcinogen in powder form. On January 30, 2020, the EP rejected a motion from ECR to object to the proposed classification of titanium dioxide as a carcinogen.

EFSA Begins Public Consultation On Draft Scientific Opinion On Risks To Human Health Related To Presence Of PFAS In Food: 

The European Food Safety Authority (EFSA) Panel on Contaminants in the Food Chain (CONTAM) began a public consultation on February 24, 2020, on its draft scientific opinion on the risks to human health related to the presence of perfluoroalkyl substances (PFAS) in food. The EC asked EFSA for a scientific evaluation of the risks to human health related to the presence of PFAS in food. The CONTAM Panel states that based on several similar effects in animals, toxicokinetics, and observed concentrations in human blood, it decided to perform the assessment for the sum of four PFAS: perfluorooctanoic acid (PFOA); perfluorononanoic acid (PFNA); perfluorohexane sulfonic acid (PFHxS); and perfluorooctane sulfonate (PFOS). The draft scientific opinion presents estimations of human dietary exposure to PFAS and an assessment of human health risks related to dietary exposure to PFAS. According to an explanation of the draft scientific opinion, the CONTAM Panel proposed a group tolerable weekly intake (TWI) for four main PFAS that accumulate in the body, identified the most exposed population groups, and identified the critical effect linked to exposure to PFAS in animals and humans. The Panel also identified the foods that contribute most to the exposure to these four PFAS -- drinking water, fish, fruit and fruit products, and eggs and egg products. Comments are due April 20, 2020.

ECHA Increases Compliance Checks By 50 Percent: 

On February 26, 2020, ECHA issued a press release entitled “50 % more REACH dossiers checked for compliance in 2019.” In its press release, ECHA indicates that it increased, in 2019, “the number of checks carried out on companies’ chemical safety data by 50 %.” ECHA states that important safety data have been requested to clarify long-term effects of chemicals on human health and the environment, “including those affecting reproduction and causing genetic mutations.”

ECHA provides that it conducted, in 2019, “301 in-depth checks on almost 3 000 dossiers, covering 274 unique chemicals.” ECHA indicates that decisions “to make the registration compliant” were sent to all registrants of the chemical, a change to the “earlier practice where only the lead registrant was contacted.” ECHA states that this measure contributed to a better collaboration among co-registrants. ECHA provides that “[m]ore checks were also done on dossiers from companies that registered their chemicals separately from joint submissions.”

ECHA states that it has continued to focus on information needed to clarify long-term effects on human health or the environment. ECHA provides that information was requested in 245 of the 301 checks, with “most asking to clarify long-term effects on the development of unborn children, genetic mutations, and aquatic toxicity.” ECHA indicates that in the past decade it has carried out an in-depth check of more than 1,000 chemicals across all tonnage bands. ECHA states that more than 20 percent of “the large volume chemicals with the highest potential exposure” have been checked in depth.

In regard to substance evaluation conducted at Member State level, ECHA provides that 264 chemicals were evaluated between 2012 and 2019. For 181 chemicals, further information was needed to clarify suspected concerns. ECHA indicates that for “around one-third of the 181 chemicals, risk management was needed.” More information is available in ECHA’s evaluation statistics.

ECHA Calls For Comments And Evidence For OELs For Asbestos And Cadmium And Inorganic Compounds: 

On March 2, 2020, ECHA started two calls for comments and evidence:

  • Call for evidence on asbestos and its properties related to scientific evaluation of exposure limits at the workplace: ECHA is reviewing the current occupational exposure limit (OEL), which imposes on employers the obligation to ensure that no worker is exposed to an airborne concentration of asbestos in excess of 0.1 fibers per cubic centimeter (cm3) as an eight-hour time-weighted average (TWA) in accordance with Article 8 Directive 2009/148/EC on the protection of workers from the risks related to exposure to asbestos at work. ECHA states that any exposure to asbestos should be limited to the minimum and that OELs “are one crucial element in achieving that goal.” According to ECHA, while new uses of asbestos-containing products are already prohibited in the EU, due to the large amount of previously used asbestos products still in place, the preventive actions related to the safe handling of those products (e.g., during building renovation and maintenance) will remain a priority for many years to come. The call intends to gather information on exposure, health effects, toxicology, epidemiology, and modes of action. The information gathered will form the basis when preparing the scientific report.

  • Call for evidence on cadmium and its inorganic compounds and its properties related to scientific evaluation of exposure limits at the workplace: ECHA is assessing the option of an airborne OEL and/or a combination of an airborne OEL and a biological monitoring value for cadmium and its inorganic compounds based on their possible equal effectiveness in protecting the health of workers. The scientific evaluations of 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 Carcinogens and Mutagens Directive (Directive 2004/37/EC). The call intends to gather any new scientific information since the scientific opinion by the Scientific Committee on OELs (SCOEL) (2017) on uses, exposure, health effects, toxicology, epidemiology, and modes of action on cadmium and its inorganic compounds. The information gathered will form the basis when preparing the scientific report.

Comments and evidence are due June 2, 2020.

ECHA Holds Webinar On EUCLEF: 

According to ECHA, the EU Chemicals Legislation Finder (EUCLEF) will go live in March 2020, enabling companies, especially SMEs, to find out how their substances are being regulated in the EU and what legal obligations they have. Through EUCLEF, stakeholders will have access to a much wider range of legislative information, “seamlessly integrated into [ECHA’s] chemicals database.” ECHA expects EUCLEF to cover 40 pieces of EU legislation and will later expand it to include more. ECHA held a webinar on March 4, 2020, to provide a preview of how EUCLEF works.

ECHA Will Hold Safer Chemicals Conference In June 2020: 

On June 2-3, 2020, ECHA will hold the Safer Chemicals Conference 2020. The program includes the following sessions:

  • How to notify articles containing substances of concern to the SCIP database;

  • How to notify hazardous mixtures to poison centers;

  • Safer chemicals for a greener Europe;

  • Tracking substances of concern;

  • Managing a biocidal product family; and

  • Harmonized information to poison centers.

ECHA states that the conference is open to all, but it will be particularly useful for companies supplying articles containing SVHCs; companies placing hazardous mixtures on the EU market; and companies placing biocidal products on the EU market. The conference will be web-streamed live.

INDIA

India Notifies WTO Of Intent To Make A Number Of Chemical Standards Mandatory: 

In February 2020, India notified the World Trade Organization (WTO) that it intends to make certain chemical standards mandatory to protect human health and the overall ecosystem. The notifications include the following chemicals and their usage (notification spelling of the chemical names is used):

  • Phosphorous trichloride (used as a chemical intermediate to produce a variety of products that are used in several applications, including agricultural products, surfactants and metal extractants, flame retardants, and additives for lubricants);

  • Potassium carbonate anhydrous (used as a dehydrating agent and for making other potassium salts, such as chlorates and chromates; also used in ceramics, explosives, fertilizers, mineral water, tanning electroplating, shampoo preparations, process engraving and soft soaps, textile dyeing, bleaching and finishing oil, and photography);

  • Acetone (an important commercial solvent and raw material with a wide usage in the chemical, explosives, and lacquer industry);

  • Beta picoline (used in the manufacture of agrochemicals, vitamin B3, thermoplastics, and polymers);

  • Gamma picoline (used in the polymer industry to make 4-vinylpyridine, which is used to manufacture polymers and pharmaceutical intermediates; also used in the pharmaceutical industry for the manufacture of isoniazid, a drug used to treat tuberculosis);

  • Hydrogen peroxide (mainly used as an oxidizing and bleaching agent in industry, as well as a disinfectant);

  • Morpholine (an extremely versatile chemical with many important applications, including as an intermediate in the manufacture of rubber chemicals, optical brighteners, resins and dyes, and as a corrosion inhibitor in steam boiler systems);

  • Phenol (used as an antiseptic, germicide, and disinfectant, as well as in the manufacture of dyes and picric acid; industrial applications include phenol formaldehye resins, poly carbonates, laminates, plywood, expoxides, phonexy herbicides, and numerous pharmaceutical drugs);

  • Phosphorous oxychloride (widely used as a catalyst and chlorinating agent in the dyestuff, pesticide, and pharmaceutical industries);

  • Phosphorous pentachloride (mainly used as a chlorinating agent in the manufacture of pharmaceuticals, dyestuffs, and pesticides);

  • Pyridine (used as a solvent in the dyestuff and pharmaceutical industries and as a laboratory reagent; also used in the manufacture of drug intermediates, vitamins, adhesives, food flavoring agents, and pesticides);

  • Sodium sulphide (widely used in the paper and pulp industry, tanneries, dyestuff and textile industries, and ore beneficiation);

  • Sodium formaldehyde sulfoxylate (a powerful reducing agent that also finds extensive applications in the textile industry for printing and stripping dyed textiles prior to redyeing and discharge printing; also used in bleaching sugar cane juice for making jaggery, as a redox catalyst in emulsion of polymers, and as a stabilizer/anti-oxidant in pharmaceutical drug formulations; and also as a water conditioner, reducing the amount of chlorine); and

  • Barium carbonate (an important raw material widely used in the manufacture of different types of ceramic dielectric capacitors for high-frequency application and for hard ferrites; another important use is as an ingredient for the manufacture of ceramic glaze frits and fluxes, optical and ophthalmic glasses, and special cut glasses; also used in other electroceramic materials used in resistors and circuit breakers).

India did not provide WTO the proposed date of adoption or entry into force.

MEXICO

Draft Standard On Labeling Requirements For Paints And Related Products Available For Comment: 

On January 27, 2020, Mexico published a draft standard on the labeling requirements for paints and related products such as finishes, coatings, inks, printing inks, sealants, varnishes, lacquers, enamels, hardeners, catalysts, accelerators, activators, two-component products, retarders, reducers, thinners, removers, dryers, conditioners, cleaning solvents, and wax and grease removers. The draft standard includes precautionary statements that would be required for solvent-based and water- or vegetable oil-based products. It also specifies the labeling and packaging elements. The standard would not apply to adhesives, glues, and primers. Compliance would be required for products manufactured after the standard enters into force. Comments are due March 27, 2020.

ORGANIZATION FOR ECONOMIC COOPERATION AND DEVELOPMENT (OECD)

OECD Releases New eChemPortal Version 3.0 With Improved Search Functionality: 

On February 3, 2020, OECD announced the release of eChemPortal version 3.0, which includes an update of the user interface architecture, a refreshed design, and more efficient searching, including direct searching from the home page. eChemPortal allows simultaneous searching of reports and data sets by chemical name and number, by chemical property, and by Globally Harmonized System of Classification and Labeling of Chemicals (GHS) classification. Direct links to collections of chemical hazard and risk information prepared for government chemical review programs at national, regional, and international levels are provided, as well as classification results according to national/regional hazard classification schemes or to GHS. eChemPortal also provides exposure and use information on chemicals. OECD is responsible for the development and maintenance of eChemPortal, and eChemPortal is hosted by ECHA. Free webinars and training events will be organized upon request to echemportal@oecd.org.

OECD Launches New Version Of QSAR Toolbox: 

OECD announced on February 11, 2020, that Quantitative Structure-Activity Relationship (QSAR) Toolbox version 4.4 is available. New features of the QSAR Toolbox version 4.4 include:

  • New Simplified Toolbox interface to introduce new users to the Toolbox. Data, profiler, and metabolic results, as well as potential analogues for a chemical of interest, can be retrieved and exported;

  • New Toolbox Repository allows third parties to develop their own extensions and make them available to the entire Toolbox community; and

  • Includes ECHA REACH extension for including REACH data in Toolbox reports and Japan’s KAshinhou Tool for Ecotoxicity (KATE).

RUSSIA

Russia Extends Deadline To Nominate Substances To Chemical Inventory: 

The Russian Federation continues its implementation of Decree No. 1019 on the Technical Regulation on the Safety of Chemical Products, issued in October 2016, to establish a chemicals framework. The process to submit substance information to the chemical inventory began in November 2019 with a deadline of January 1, 2020. On February 17, 2020, the Ministry of Industry and Trade of the Russian Federation announced its extension of the deadline to submit substances to the inventory from January 1, 2020, to May 1, 2020. Companies preparing to submit information to the chemical inventory should take note of the following aspects of the Russian chemical inventory framework:

  • Only Russian entities can submit substances to the chemical inventory. A non-Russian entity may appoint an Authorized Representative (AR) to submit substances on its behalf;

  • Polymers need not be submitted to the inventory, but all monomers, additives, and other components at greater than 0.1 percent must be submitted;

  • There is no confidential chemical inventory in the Russian Federation;

  • Manufacturer names are not linked to chemical inventory listings if an AR is used to submit the substance to the inventory;

  • There is no exemption for impurities. All substances present above 0.1 percent must be on the chemical inventory and should be submitted; and

  • Chemical substances, either present on the market or planned to be placed on the market, are eligible for submission to the inventory.

Substances not placed on the inventory during this open notification period will be considered new chemicals and will require full registration prior to placing them on the market.

UNITED KINGDOM (UK)

Cefic And CIA Issue Joint Memorandum On Brexit And REACH: 

The European Chemical Industry Council (Cefic) and the Chemical Industries Association (CIA) have issued a joint memorandum entitled “REACH related issues in the future relationship between the EU-27 and the [UK].” The memorandum indicates that the “preferred option” for the post-transition period UK-EU relationship is a strong partnership comprising a deep and comprehensive free trade agreement. The memorandum indicates “this agreement should secure, at the minimum, frictionless trade in chemicals and the highest degree of regulatory cooperation between the UK and the EU-27.”

Cefic and CIA highlight the importance of UK-EU regulatory cooperation and state that “negotiating a partnership that is significantly closer than that one envisaged by existing cooperation agreements between ECHA and some non-EU countries is of paramount importance.” The memorandum highlights challenges posed by two “separate legislative systems” in the EU and UK, indicating that the “immediate cost is expected to be over £1 billion in addition to the existing cost of REACH which is estimated at 10 bn euro.”

The memorandum provides the following proposed approach:

  • Continued UK participation in EU chemical regulations: “Our ideal scenario would be a maximum degree of cooperation implying that the UK remains part of the EU-REACH framework, still accessing the services of ECHA. The UK would continue to be an active participant in ECHA, albeit without voting rights but making an appropriate financial contribution.”

  • Consider the need for a shared REACH database: Access to ECHA’s database by the UK regulatory authorities should be negotiated. Article 120 of REACH foresees the potential scenario of an agreement on access to data held by ECHA, and “[w]e believe this option should be explored during the next phase of negotiations. … Registrations, authorisations, and notifications obtained by UK as well [as] non-UK companies under EU legislation could be recognised and accepted in the UK and EU without the need of multiple registrations for the same product.”

  • Smoothly planned transition.

In conclusion, the memorandum highlights the advantages of the proposed approach and states “[w]hatever shape the future relationship may eventually take, first and foremost we are urging negotiators to ensure that the regulatory systems of the EU-27 and the UK remain highly aligned and go beyond existing cooperation agreements between ECHA and some non-EU countries. … To avoid the risks Brexit imposes, we urge the UK to remain part of EU agencies, including ECHA. To do that, we suggest that the approach outlined in this paper should be negotiated.”

©2020 Bergeson & Campbell, P.C.National Law Review, Volume X, Number 65
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The Acta Group (Acta®) is the consulting affiliate of Bergeson & Campbell, P.C. (B&C®), established to complement B&C’s legal services by providing a full-range of support for the process of marketing chemicals, biocides, and products of industrial biotechnology, nanotechnology, and synthetic biology. Acta knows that clients must function optimally in all jurisdictions in which they market and/or place products to remain competitive. We help them get there through our global reach....

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