Global Regulatory Update for May 2018
Update on Status of Regulação de Substâncias Químicas Industriais (Industrial Chemicals Regulation) – The Brazilian Ministério do Meio Ambiente (Ministry of Environment; MMA), held its most recent meeting of the Comisión Nacional de Seguridad Química (National Commission of Chemical Safety; CONASQ) on February 22-23, 2018. The CONASQ meeting continued the previous process of discussing the 801 responses received in the public consultation related to the draft Regulação de Substâncias Químicas Industriais (Regulation) published on June 30, 2016.
The Acta Group’s (Acta®) MMA contact has estimated that they have discussed approximately 40 percent of all the comments received. Due in large part to this prolonged evaluation process, as well as current and upcoming legislative changes in Brazil, it is expected that the final version of the Regulation will not be presented for a vote in the Congress before the third quarter of 2018, if not later.
Brazil Issues Draft Resolution Regarding Toxicological Information For Pesticide and Related Products Labels — Brazil’s Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency; ANVISA) has issued Draft Resolution N° 483, “Toxicological Information For Labels and Leaflets of Pesticides, Related Products and Wooden [sic] Preservatives.” Draft Resolution N° 483 sets out the obligatory information related to the protection of human health that must be included on pesticide labels and leaflets and similar products and wooden preservatives, as well as adopting the labeling guidelines of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The company is responsible for all labeling and package leaflet information, must present it clearly, and must ensure that it is adequate and sufficient for health protection purposes. In addition, ANVISA directs that the pictograms recommended by the Food and Agriculture Organization (FAO) of the United Nations (UN) should be used on pesticide labels and leaflets, as well as on wood preservatives.
Similar to the U.S. Environmental Protection Agency (U.S. EPA), ANVISA may, at its discretion and with a reasoned technical justification, require the company that holds the registration to change the texts of labels and package leaflets. Companies with already-registered pesticides and wood preservatives must comply with this Resolution, if/when final, up to 360 days after the enactment. Notably, such companies may implement the labeling and related changes without prior authorization from ANVISA.
ANVISA Amends 2015 Regulation Requiring Personal Care Products, Cosmetics, and Perfumes Registration — Under its recently-published Draft Resolution Nº 500, ANVISA has amended Resolution RDC 7, of 10 February 2015, specifically Annexes II and VIII. Resolution RDC 7 established the personal care products, cosmetics, and perfumes that were subject to registration prior to commercialization. Most notably, the list of product types in Annex VIII that require registration has been reduced from 23 to eight. These eight are: tanning products, sunscreens, children’s sunscreens, antiseptic hand gel, hair straightening products, hair straightening and dyeing products, insect repellents, and infant insect repellants. Note that Draft Resolution Nº 500 does not necessarily group like products together (e.g., “sunscreens” and “children’s sunscreens” are two different categories in the Resolution.
Canada Releases New Educational Primer On Chemical Regulations In Canada And The U.S.: On April 13, 2018, Environment and Climate Change Canada, Health Canada, and U.S. EPA published an educational primer on Canadian and U.S. regulations regarding new uses of chemical substances. The primer was developed by the Canadian and U.S. governments with a technical working group, comprised of industry and other stakeholders, acting as an advisory body. The information is organized by jurisdiction, beginning with significant new use rule (SNUR) program information, and followed by significant new activity (SNAc) provision details. Topics include: an overview of significant new uses/significant new activities; how individuals can determine if a SNUR/SNAc applies to their activities; where to find information about published SNURs/SNAcs, and notification requirements in the U.S. and Canada for SNURs/SNAcs.
Canada Amends Hazardous Products Regulations To Protect CBI: On April 18, 2018, Canada published a notice in the Canada Gazette amending the Hazardous Products Regulations. Under the amendment, if the concentration of a material or substance in a hazardous product must be provided on the safety data sheet (SDS) and the material or substance is always present at the same concentration, the SDS must provide:
- The actual concentration of the material or substance in the hazardous product; or
- One of the concentration ranges within which the actual concentration of the material or substance in the hazardous product falls.
If the concentration of a material or substance in a hazardous product is not always present at the same concentration, the SDS must provide:
- The actual concentration range of the material or substance in the hazardous product;
- One of the concentration ranges within which the actual concentration range of the material or substance in the hazardous product falls entirely; or
- If the actual concentration range of the material or substance in the hazardous product is equal to or greater than 0.1 percent but less than or equal to 30 percent, and the actual concentration range does not fall entirely within any of the concentration ranges, a concentration range that is created by combining two consecutive ranges, provided that the combined concentration range does not include any range that falls entirely outside the actual concentration range in which the material or substance is present in the hazardous product.
If the SDS provides a concentration range, it must also provide a statement that the actual concentration range is withheld as a trade secret.
EUROPEAN UNION (EU)
ECHA Adopts Updated CoRAP, 21 Substances Specified For 2018: The European Chemicals Agency (ECHA) announced on March 20, 2018, that it adopted the updated Community Rolling Action Plan (CoRAP) with 108 substances to be evaluated in 2018-2020. Member state authorities have 12 months to evaluate the 21 substances specified for 2018. The evaluation is intended to clarify whether these substances pose a risk to people or the environment. If necessary, the registrants will be asked to provide further information on the substance so that the authorities can assess the suspected concern. ECHA encourages registrants of the listed substances to coordinate their actions and to contact the evaluating Member State. Registrants are also urged to update their dossiers, especially for uses and exposure scenarios. They will have an opportunity to comment before any decision to request further information is taken. Such draft decisions will be reviewed by the other Member States and ECHA before the final decision is issued. ECHA states that the substances selected for evaluation to clarify the concerns related to their exposure and suspected serious hazard properties are: persistent, bioaccumulative, and toxic (PBT), carcinogenic, mutagenic, or toxic for reproduction (CMR), or endocrine disruptors in combination with wide dispersive consumer use. ECHA notes that other concerns on the substances may be identified during evaluation. More information is available in ECHA’s press release, “Member States start evaluating 21 substances in 2018.”
RAC Recommends OELs For Benzene, Nickel, And Acrylonitrile: On March 21, 2018, ECHA announced that the Committee for Risk Assessment (RAC) recommended occupational exposure limits (OEL) for benzene, nickel and its compounds, and acrylonitrile. ECHA’s press release, “RAC recommends an occupational exposure limit for benzene,” states that:
- Benzene is a genotoxic carcinogen, known to cause leukaemia. RAC is of the opinion that a threshold based on the indirect (i.e., not directly DNA-damaging) genotoxic effects of benzene in workers can be used to derive a new occupational exposure limit. The proposed OEL of 0.05 parts per million (ppm) will protect workers from leukaemia, as well as other adverse health effects. Exposure to benzene occurs in the petroleum and chemical industries and also as a result of gasoline engine emissions and combustion products;
- RAC proposed an OEL of 0.45 ppm for acrylonitrile, a monomer used in many plastics; and
- For nickel and its compounds, RAC proposed OELs of 0.005 milligrams per cubic meter (mg/m3) for respirable dust and 0.03 mg/m3 for inhalable dust.
The press release states that the proposed OELs are based on the latest scientific evidence and were subject to public consultation. In addition, industry and trade unions were able to attend the RAC plenary sessions and provide further comments on RAC’s draft opinions. In March 2017, the European Commission (EC) requested that RAC provide within a year scientific opinions on five OELs for chemicals under occupational safety and health legislation for consideration by the EC’s Advisory Committee on Health and Safety at Work. According to the press release, the scientific advice from RAC will help the EC to amend existing or add new OELs to the Carcinogens and Mutagens Directive and better protect workers from cancer-causing chemicals.
EC Notifies WTO Of Draft Regulation Restricting Phthalates: The EC notified the World Trade Organization (WTO) on March 28, 2018, of a draft regulation that would amend Annex XVII of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to restrict the use of bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP), and diisobutyl phthalate (DIBP). The draft regulation would prohibit the use as substances or in mixtures in a concentration equal to or greater than 0.1 percent by weight of the plasticized material in toys and childcare articles of DIBP and the placing on the market in articles of any of the listed four phthalates — DEHP, DBP, BBP, and DIBP — in a concentration that is equal to or greater than 0.1 percent by weight in any plasticized material in the article. The notification notes that some derogations are provided. The proposed date of adoption is the second half of 2018. The regulation would enter into force 20 days after its publication in the Official Journal of the European Union. The restrictions would apply 18 months after the regulation enters into force. Comments are due May 27, 2018.
Board Of Appeal Issues Decision In Joint Submission Dispute In Case Of A “Complete Opt-Out”: ECHA announced on March 28, 2018, that the Board of Appeal has issued its decision in case A-011-2017, concerning the joint registration for charcoal. The Board of Appeal found the case to be inadmissible. By the decision under appeal, ECHA granted a registrant “access to the joint submission” and issued a “token” to enable this to happen. The registrant in question wished to join the joint registration for charcoal while relying on a “complete opt-out” from all information in the lead registrant’s dossier. The lead registrant challenged the ECHA decision before the Board of Appeal. ECHA states that the Board of Appeal found that, if a registrant decides to rely on a “complete opt-out” and informs ECHA and the lead registrant accordingly, the registrant cannot be prevented from making its separate submission part of the joint registration. Based on REACH Article 11, supported by Article 3(3) of the Commission Implementing Regulation on data-sharing, ECHA must give such a registrant access to the joint registration. ECHA is not first required to examine whether the registrant has made “every effort” to agree on the terms to obtain the “token” from the lead registrant. The Board of Appeal concluded that the decision to grant access to the joint submission to a registrant who relies on a complete opt-out is taken under REACH Article 11. As Article 11 does not fall under the competence of the Board of Appeal, the Board of Appeal found the case to be inadmissible. More information is available in ECHA’s March 28, 2018, press release, “Board of Appeal decision on a joint submission dispute in case of a ‘complete opt-out.’”
ECHA Begins Public Consultation On Strategic Priorities For Next Five Years: On April 4, 2018, ECHA announced that it has launched a public consultation on its draft Strategic Plan for 2019-2023. ECHA states that by 2023, it “aims to become the main source of scientific knowledge and technical know-how on chemicals, serving a wide range of EU policies and stakeholders.” The draft Strategic Plan lists three strategic priorities that are to be achieved with a set of enabling components:
- Identification and risk management of substances of concern;
- Safe and sustainable use of chemicals by industry; and
- Sustainable management of chemicals through the implementation of EU legislation.
Once final, the Strategic Plan will become the multi-annual part of the Programming Documents of ECHA for 2019-2021 and beyond. Steered by the strategy, ECHA will establish annual Work Programs containing specific actions and outputs planned for each year. The areas of operation in the Strategic Plan per each strategic objective and the enabling components aim to provide a framework for the annual Work Programs and are thus more generic. Comments on the draft Strategic Plan are due May 4, 2018.
ECHA Preparing To Send Registrants Draft Decisions On Information Requests For 16 Substances: ECHA announced on April 10, 2018, that it will send out substance evaluation draft decisions to up to 200 registrants in early June 2018, instead of April 2018, to allow the registrants to focus on their REACH registrations with a May 31, 2018, deadline. According to ECHA, the draft decisions will address substances that were evaluated by Member States in 2017 and on which the Member State concluded that further information is required to clarify the identified concerns. Registrants will have 30 days to consider and submit their comments. ECHA recommends that one representative send consolidated comments on behalf of all addressed registrants of a substance. ECHA will send draft decisions to all registrants of the substance, including those who have by that date submitted a registration that is not yet complete in the submission pipeline. Recipients will also include registrants of transported isolated intermediates. ECHA states that registrants for on-site isolated intermediates will not receive draft decisions for commenting. In one “exceptional” case (ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate), the registrants of the substance will receive a draft decision for commenting in April 2018. ECHA has informed the affected registrants in advance, providing the specific reasons for this timeline. In 2017, Member States evaluated 22 substances listed in the CoRAP. In 16 cases, further information is expected to be needed to assess the safety of the substance and a draft decision was prepared to request this data. For six substances, the evaluating Member State concluded that no further data are needed. ECHA will publish the conclusion documents with possible indications for further regulatory action “in due course.” More information is available in ECHA’s press release, “Registrants: get ready to comment on the 2017 substance evaluation draft decisions.”
ECHA Recommends Pre-Submission For EU Authorization For Biocidal Products: ECHA issued an April 11, 2018, press release to urge companies interested in EU authorization to keep their biocidal products on the market to check the substance-specific deadlines on its website and apply on time. EU authorization allows companies to place a biocidal product on the market throughout the EU without the need for specific national authorization. According to ECHA, 16 active substances have upcoming deadlines for different product-types. ECHA recommends companies make a pre-submission to ECHA at least six months before submitting an EU authorization application. ECHA states that this “free-of-charge consultation helps identify any potential issues that need to be addressed.” More information is available in ECHA’s press release, “Are you interested in Union authorisation for your biocidal product?”
EC Proposal Foresees Proactive Disclosure Of Industry Studies In Food Safety Area: On April 11, 2018, the EC announced a proposal intended to improve the transparency of scientific studies in the food safety area. The EC issued the proposal in response to concerns expressed by citizens in a successful European Citizens’ Initiative. The proposal “foresees the proactive disclosure of industry studies.” According to the EC, the key elements of the proposal will:
- Ensure more transparency, by allowing citizens to have automatic and immediate access to all safety related information submitted by industry in the risk assessment process;
- Create a common European Register of commissioned studies to guarantee that companies applying for an authorization submit all relevant information and do not withhold unfavorable studies;
- Allow additional studies to be requested by the European Food Safety Authority (EFSA), upon request of the EC and financed by the EU;
- Require consultation of stakeholders and the public on studies submitted by industry to support product authorization requests;
- Increase Member States’ involvement in EFSA’s governance structure and scientific panels; and
- Strengthen risk communication to citizens with common actions intended to enhance consumer confidence by promoting public awareness, understanding, and better explaining EFSA’s scientific opinions, as well as the basis of risk management decisions.
The EC posted questions and answers, including the following:
Will confidential information be disclosed?
No, as long as this is duly justified. The proposal sets out the type of information that may be considered significantly harmful for the commercial interests concerned (positive lists of confidential items). Applicants will have to provide verifiable justification for their possible confidentiality claims on the acceptance of which EFSA will decide[.]
In any case confidential information could be disclosed in two cases:
- When urgent action is essential to protect public health, animal health or the environment;
- When the information is part of the conclusions of the EFSA opinion and relates to foreseeable health effects.
How will the studies be disclosed and how will confidential information be processed in practice?
When the applicant submits a dossier, it may request certain parts of the submitted studies and other information to be kept confidential, with the condition that verifiable justification for this request is provided. To this end, it should submit a non-confidential version and a confidential version of the submitted studies and other information.
Without delay, EFSA would make the non-confidential version of the submitted studies and information public. In parallel, within a short period from the date of receipt, EFSA would assess the confidentiality claim. Once the assessment is completed, any additional data and information for which confidentiality requests has been considered as unjustified would also be made public.
The EC will submit the legislative proposal to the European Parliament (EP) and the EU Member States for adoption. The EC states that it aims for the proposal to be adopted by mid-2019, in the current legislative period, for swift implementation.
Authorities Will Focus On Identifying Substances Of Potential Concern: ECHA announced on April 17, 2018, that it has published its annual report describing the progress in implementing the Substances of Very High Concern (SVHC) Roadmap. The focus of the screening has shifted from systematically screening the information available in the REACH registration dossiers and in other databases to looking at groups of substances with similar hazardous properties. According to ECHA, this will enhance the coherence of regulatory action of similar substances and help to avoid “regrettable substitution” of SVHCs, as well as allow well-informed decisions to be made on a higher number of substances in a shorter period of time. Currently, new data are being generated or are under assessment on 750 substances. The annual report provides further details on the number and type of substances that authorities are working on to clarify their priority for further information generation and for further regulatory action. The generated data will enable authorities to confirm or refute the identified concerns and to initiate regulatory risk management where needed. The report also contains an analysis of the regulatory status of all currently known SVHCs, which include substances that are PBT, very persistent and very bioaccumulative (vPvB), endocrine disruptors, and/or CMR. The report concludes that all these substances have been or are being scrutinized and put forward to the relevant regulatory risk management processes, such as inclusion in the Candidate List, authorization, restriction, and harmonized classification and labeling. Alternatively, concerns regarding a substance have been or are being addressed under other EU legislation. Some substances are also considered not to require further regulatory risk management action at present.
ECHA states that, together with the EU Member States and the EC, it will now focus on all remaining substances that have been registered above 100 tonnes per year and will aim to clarify whether these are of concern. This work will be done by incorporating REACH and Classification, Labeling and Packaging of Substances and Mixtures (CLP) regulation processes into the Integrated Regulatory Strategy, which will continue the work started by the SVHC Roadmap. The Integrated Regulatory Strategy aims to:
- Efficiently select substances that raise potential concern, generating the necessary information for assessing their safety to subsequently being addressed through the most suitable regulatory risk management instrument;
- Ensure appropriate and timely intervention from all actors; and
- Enhance confidence among stakeholders and the public that registrants meet REACH information requirements, followed up by improved communication on safe use in the supply chain.
More information is available in ECHA’s press release, “Authorities to focus on identifying substances of potential concern.”
NMP Included In REACH Annex XVII: 1-methyl-2-pyrrolidone (NMP) has been added to the REACH Annex XVII list regarding “Restrictions on the Manufacture, Placing on the Market and Use of Certain Dangerous Substances, Mixtures and Articles.” NMP, which is suspected of being reprotoxic, is already included in REACH Annex XVII under Entry 30. Consequently, sale of consumer products containing more than 0.3 percent NMP is prohibited.
The latest restriction proposal for NMP, provided by the Netherlands, was approved in October 2017. Commission Regulation (EU) 2018/588 was published in the Official Journal of the EU on April 19, 2018. The Regulation amends REACH Annex XVII to include a new entry specific to NMP. The following restrictions are imposed by the new REACH Annex XVII entry for NMP:
- Shall not be placed on the market as a substance on its own or in mixtures in a concentration equal to or greater than 0.3 percent after May 9, 2020, unless manufacturers, importers, and downstream users have included in the relevant chemical safety reports and safety data sheets Derived No-Effect Levels (DNEL) relating to exposure of workers of 14.4 mg/m3 for exposure by inhalation and 4.8 mg/kg/day for dermal exposure.
- Shall not be manufactured, or used, as a substance on its own or in mixtures in a concentration equal to or greater than 0.3 percent after May 9, 2020, unless manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified above.
- By way of derogation from the two paragraphs above, the obligations laid down therein shall apply from May 9, 2024, in relation to placing on the market for use, or use, as a solvent or reactant in the process of coating wires.
EC Adopts Scientific Criteria For Determination Of Endocrine Disrupting Properties In Plant Protection Products: On April 20, 2018, the EC published in the Official Journal of the European Union an amendment to Regulation (EC) No 1107/2009 on plant protection products. At the Standing Committee on Plants Animals Food and Feed (PAFF) Pesticides legislation meeting on December 12-13, 2017, EU national representatives voted in favor of a new draft regulation setting criteria for the identification of endocrine disruptors in the context of the pesticides legislation. The EC states that neither the Council nor the EP objected to the draft criteria during the scrutiny period, which ended on April 9, 2018. The EC adopted the criteria on April 19, 2018. The criteria for plant protection products entered into force on May 10, 2018, and will apply from October 20, 2018, to all new and ongoing applications for plant protection products. Beginning October 20, 2018, an active substance, safener, or synergist shall be considered as having endocrine disrupting properties that may cause adverse effect in humans or non-target organisms if it meets the following criteria, unless there is evidence demonstrating that the adverse effects identified are not relevant to humans or are at the (sub)population level for non-target organisms:
(1) It shows an adverse effect in an intact organism, its progeny, or in non-target organisms, which is a change in the morphology, physiology, growth, development, reproduction, or life span of an organism, system, or (sub)population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress, or an increase in susceptibility to other influences;
(2) It has an endocrine mode of action, i.e., it alters the function(s) of the endocrine system; and
(3) The adverse effect is a consequence of the endocrine mode of action.
Most Inspected Internet Advertisements For Hazardous Chemicals Lack Required Warning: ECHA issued a press release on April 23, 2018, announcing the results of an enforcement project that checked online advertisements for hazardous chemical mixtures. According to ECHA, a total of 1,314 Internet advertisements were checked, with 1,083 (82 percent) found to be non-compliant with CLP. ECHA states that the majority of the non-compliant advertisements did not contain the required information on hazards. The aim of the enforcement project was to check whether the advertisements of hazardous chemical mixtures offered for sale on the Internet comply with the requirements of CLP Article 48(2). This provision states that an advertisement for a mixture classified as hazardous has to mention the hazard indicated on the label if the mixture can be purchased without first seeing the label. Enforcement authorities carried out the desktop inspections from January to August in 2017. Of the checked websites, 95 percent were professional Internet shops. The majority of the inspected mixtures were used for household (37 percent), construction (16 percent), and motor products (14 percent). In cases of non-compliance, inspectors took appropriate enforcement measures to remedy or sanction it. According to ECHA, in most cases, written or verbal advice was given, but other measures, such as fines, administrative orders, or criminal complaints, were also taken. More information is available in ECHA’s April 23, 2018, press release, “82% of inspected internet advertisements for hazardous chemicals lack required warning.”
Distributors Assuming The Role Of An Importer Are Within The Scope Of DCG Solution 21: On April 25, 2018, ECHA issued a press release entitled “Distributors taking up the role of importer are within the scope of a [Directors’ Contact Group (DCG)] solution.” The DCG is an informal group of directors from the EC, ECHA, and industry associations established to respond to companies’ concerns related to REACH registration obligations.
DCG Issue 21 relates to substances with no registration intentions from an EU manufacturer or importer, and was originally applied only to downstream users taking on importer status under REACH. In its Solution, the DCG provides advice for companies intending to use or distribute such a substance.
In its press release, ECHA states “[t]o ensure a steady supply of substances critical to EU businesses, the [DCG] has agreed to extend its solution to issue 21 to distributors … The DCG issue 21 states that downstream users may step up and register their critical substances themselves, if no registration is planned by an EU manufacturer or importer. In practice, many downstream users approach their suppliers, who are EU-based distributors of chemicals, to take up the importer role. Therefore, the DCG has decided to explicitly include the distributors within the scope of the solution.”
If a distributor applies for the DCG Solution due to difficulties in obtaining all the required information for its substance registration by the May 31, 2018, deadline, ECHA will assess its case. Based on the evidence regarding specific circumstances, ECHA can give the distributor a reasonable timeframe to complete its registration.
REACH Committee Approves Draft Regulation To Amend The REACH Annexes To Address Nanomaterials: The REACH Committee voted on April 26, 2018, to amend several REACH Annexes to clarify the registration requirements for nanomaterials. According to ECHA’s press release, the amendments address the knowledge gap regarding which substances registered under REACH are placed on the market as nanomaterials and in what quantities. ECHA states that the amendments will allow both companies and authorities to know more about the characteristics of nanomaterials, how they are used, how they are handled safely, what risks they potentially pose to health and the environment, and how these risks are controlled. The draft regulation is now subject to scrutiny by the EP and Council for a period of three months before being adopted by the EC. ECHA states that it will begin to assess the need to update existing guidance or issue new guidance to support registrants in complying with the new requirements. As soon as the amendments are formally adopted, ECHA encourages registrants of nanoform substances to familiarize themselves with the amendments and assess what actions they need to take to comply. The EC held a public consultation in 2017 on a draft regulation that would amend the Annexes. More information on the draft regulation is available in ECHA’s April 26, 2018, press release, “ECHA welcomes improved clarity on nanomaterials in the EU – Member States vote to amend REACH Annexes.”
Cefic Issues REACH 2018 FAQs: The European Chemical Industry Council (Cefic) has published Frequently Asked Questions (FAQ) related to the upcoming REACH registration deadline. Cefic states “[a]ll chemical substances produced or imported in the EU between [one and 100 metric tons] a year need to be registered by [May 31, 2018,] with [ECHA]. With the REACH registration deadline around the corner, some may wonder whether the industry will be ready by the deadline and what will happen next.”
Cefic has provided answers to the following FAQs:
- Is the May deadline the end of the REACH journey?
- Are all EU chemicals manufacturers ready for the deadline? Are all substances registered?
- Is the chemical industry advocating for the extension of the deadline?
- Is the industry preparing any guidance on what to do for last-minute registrations or in case the substances/mixtures are no longer available on the market after the deadline?
- Does Brexit have any impact on the implementation of REACH?
Regarding the first question above, Cefic’s answer was consistent with industry’s understanding. Cefic stated:
No. The registration is just the tip of the iceberg. Below the waterline lie Evaluation, Authorisation and Restriction. Evaluation — both dossier and substance evaluation by [ECHA] — will trigger further activities from industry to obtain and provide the necessary information on hazard deficiencies, uses, tonnages and exposure. The evaluation of existing dossiers and regulatory risk management will continue as the [EC] wants to improve the implementation, which is noted in the recently published REACH review.
BPC Concludes On Four Active Substances: On April 27, 2018, ECHA issued a press release entitled “[Biocidal Products Committee (BPC)] concludes on four active substances in disinfectants and preservatives.” The BPC supported approval of the following active substances:
- Active chlorine generated from sodium chloride by electrolysis for disinfectants (product-types 1, 2, 3, 4, and 5);
- Active chlorine released from hypochlorous acid for disinfectants (product-types 1, 2, 3, 4, and 5); and
- Carbendazim for preservatives (product-types 7 and 10).
The Committee concluded that the following active substance should not be approved:
- Willaertia magna c2c Maky for preservatives (product-type 11).
The BPC’s opinion is that the amoeba Willaertia magna c2c Maky cannot be approved for product-type 11 because its efficacy is not sufficiently demonstrated, and because it cannot be excluded that there are unacceptable effects on human health due to a so-called “trojan horse” effect, with the amoeba acting as a reservoir for possible pathogenic bacteria.
The EC and EU Member States will make the final decision on the approval of the active substances. Additional information is available in ECHA’s Annex to the press release.
ECHA Announces ENES Implementation Plan 2018 And Updated Work Program: ECHA announced on May 2, 2018, the availability of the ENES Implementation Plan 2018 and ENES Work Programme to 2020. The Exchange Network on Exposure Scenarios (ENES) Work Program is a cross-stakeholder plan of actions intended to improve chemical safety assessment and communication in the supply chain. The main lines of activity and the priorities are to:
- Determine the information needs of the different actors;
- Connect practices under REACH with practices under other legislation (occupational safety and health, environment, consumer safety);
- Develop and maintain the methods and tools to collect, process, and communicate this information;
- Adapt the exposure assessment methods and tools to support the REACH safety assessment framework; and
- Convince companies (and authorities) that it is worth the effort by demonstrating usefulness and feasibility.
The Implementation Plan translates the main action areas identified in that Work Program into concrete activities for 2018. It focuses on enhancing use maps and providing registrants of substances with information on uses and the conditions of use in market sectors. Other focus areas are making exposure scenarios more understandable and useful, and developing best practices in providing safe use information for mixtures. Emphasis is also placed on the communication between formulators and end users and how each of them processes the safe use information for their tasks under REACH. More information is available in ECHA’s May 2, 2018, press release, “ENES Work Programme until 2020: Improving safe use of chemicals in supply chains.”
EP Calls For Worldwide Ban On Testing Cosmetics On Animals: On May 3, 2018, the EP passed a non-binding resolution calling for the EU to launch a diplomatic drive for a worldwide ban on testing cosmetics on animals before 2023. According to the EP’s May 3, 2018, press release, although the EU has banned the sale of all animal-tested cosmetics since 2013, approximately 80 percent of countries worldwide still allow animal testing and the marketing of cosmetics tested on animals. In addition, many ingredients in cosmetic products are also used in other products, such as pharmaceuticals, detergents, or foods, and may therefore have been tested on animals under different laws. The press release states that the lack of reliable data on cosmetics tested on animals and then imported into the EU also remains a serious issue, and the EU should make sure that no product placed on its market has been tested on animals in a non-EU country. The resolution calls on EU leaders to use their diplomatic networks to build a coalition and to launch an international convention within the UN framework. The ban should be in place before 2023. More information is available in the EP’s May 3, 2018, press release, “Testing cosmetics on animals: MEPs call for worldwide ban.”
Ministry of Health Issues Draft NOM for Household Hygiene Products – The Mexican Ministerio de Salud (Ministry of Health) has issued a draft Norma Oficial Mexicana (NOM) affecting both those persons engaged in the processing or importation of hygiene products for household use, as well as the attendant labeling and packaging.
The “Proyecto de Norma Oficial Mexicana PROY-NOM-189-SSA1/SCFI-2016, Productos y Servicios. Etiquetado y Envasado Para Productos de Aseo de Uso Doméstico” (Draft Mexican Official Standard PROY-NOM-189-SSA1/SCFI-2016, Products and services. Labelling and Packaging for Hygiene Products for Household Use) establishes the requirements for both the health and commercial information with respect to the labeling of hygiene products for household use. The manifest purpose is to provide better customer choice to prevent their use from posing a risk to health.
Hygiene products (irrespective of their physical state) are defined in the NOM as substances intended for the washing or cleaning of objects, surfaces, or buildings, and substances that release a specific fragrance into the air. These products include soaps, detergents, cleaners, whiteners, starches for external use, stain-removers, disinfectants, deodorizers and air fresheners, and other similar products.
Four Middle Eastern Countries Incorporate GCC Technical RoHS-Type Regulation Into National Law — The countries of Bahrain, Oman, Saudi Arabia, and the United Arab Emirates (a federation of seven emirates, comprised of Abu Dhabi (the capital), Ajman, Dubai, Fujairah, Ras al-Khaimah, Sharjah and Umm al-Quwain) have begun the process of incorporating the Gulf Cooperation Council’s (GCC) “Draft of GCC Technical Regulations for the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment” (Regulation) (Arabic only) into their respective national laws.
Through their respective legislative processes, Bahrain (via the Bahrain Standards and Metrology Directorate), Oman (via the National Enquiry Point and Information Centre), Saudi Arabia (via the Saudi Arabia Standards Organization), and the United Arab Emirates (via the Emirates Authority for Standardization and Metrology) are implementing the Technical Regulation that will apply to electrical and electronic equipment as defined in Annex (1) of the Regulation. Among such items are household appliances (large and small), IT and telecommunication equipment, consumer equipment, lighting, electrical and electronic tools, toys, and sporting equipment.
The Regulation sets out requirements on the restriction of the use of hazardous substances in electrical and electronic equipment, with a view to contributing to the protection of human health and the environment, including the environmentally-sound recovery and disposal of waste. These requirements must be met before such goods are made available in the GCC market.
Taiwan EPA Begins Consultation On Proposed Revisions To Registration Regulations: On March 31, 2018, the Taiwan Environmental Protection Administration (Taiwan EPA) began a public consultation on proposed revisions to the regulations regarding registration of new and existing chemical substances. Taiwan EPA’s WTO notification states that the major amendments include:
- Clarifying the scope of application of the regulations. The regulations shall not apply to toxic chemical substances, as defined by the Toxic Chemical Substance Control Act (TCSCA);
- Harmonizing the information requirement between Taiwan EPA and the Ministry of Labor (MOL) regarding hazard assessment and exposure assessment;
- Issuing the registration number, instead of the registration document for the registration approved;
- Clarifying the quantity that triggers the obligation for the existing chemical substance phase 1 registration. For an existing chemical substance manufactured or imported in the annual volume of 100 kilograms (kg) or more, the phase 1 registration must be made within six months. Also a voluntary phase 1 registration may be made for the existing chemical substance manufactured or imported in the annual volume less than 100 kgs;
- Designating the first stage of 106 chemical substances subject to the standard registration of existing chemical substances;
- Clarifying the period of the information confidentiality of chemical substances included in the inventory of existing chemical substances, and ensuring consistency in the period of the information confidentiality and the validity of registration approval;
- Requiring an annual report of the new and existing chemical substances registered and approved. For chemical substances registered and approved, an annual report shall be completed from April to September each year;
- Indicating the calculation of the review period, so that the review period is calculated anew upon the registrant’s supplementation or modification of the registration application;
- Extending the limit on the time period and the number of times that a supplementation and correction may be made for a registration application, by taking into account the scientific and technical feasibility assessed by Taiwan EPA;
- Accepting written appeals with stated reasons for which the registrant may have concerns over the review result; and
- Deleting outdated provisions.
The list of 106 priority existing chemicals (PEC) is available in the English translation submitted to WTO. Comments on the proposed revisions are due May 29, 2018.
UNITED KINGDOM (UK)
European Council Issues Brexit Guidelines: On March 23, 2018, the European Council published Guidelines regarding the post-Brexit relationship between the UK and the EU. The opening paragraph of the Guidelines states “[t]he European Council calls for intensified efforts on the remaining withdrawal issues as well as issues related to the territorial application of the Withdrawal Agreement, notably as regards Gibraltar, and reiterates that nothing is agreed until everything is agreed.”
The Guidelines indicate the EU’s determination to maintain a close partnership with the UK post-Brexit that “should cover trade and economic cooperation as well as other areas, in particular the fight against terrorism and international crime, as well as security, [defense] and foreign policy.” The Guidelines provide that any agreement with the UK will need to be based on a balance of rights and obligations, and ensure a level playing field.
Importantly, the Guidelines emphasize that the EU “will preserve its autonomy as regards its decision-making, which excludes participation of the [UK] as a third-country in the Union Institutions and participation in the decision-making of the Union bodies, offices and agencies. The role of the Court of Justice of the [EU] will also be fully respected.” The European Council’s stated exclusion of the UK from EU institutions (e.g., ECHA) is an important matter, and runs contrary to statements by the UK that it would seek associate membership of EU agencies as part of withdrawal negotiations.
The Guidelines address a number of important matters, including movement of natural persons, judicial cooperation, socio-economic cooperation, law enforcement, and data protection — and emphasize the need for a suitable post-Brexit relationship between the UK and the EU.
In conclusion, the European Council states that it “calls upon the Commission, the High Representative of the Union for Foreign Affairs and Security Policy and the Member States to continue the work on preparedness at all levels for the consequences of the UK withdrawal, taking into account all possible outcomes.”