EU REACH: Four New SVHCs Proposed

Authored by: Dr. Paul Goodman, Principal Regulatory Consultant, RINA

The European Chemicals Agency has proposed four substances to be added to the REACH Candidate List as Substances of Very High Concern (SVHC). Three of the substances are reported to be reproductive toxins and the fourth (PFBS) is a possible endocrine disrupting substance, harmful to the environment and humans, as well as being fairly persistent.

The current Stakeholder Consultation, ending on the 18th October 2019, aims to confirm whether the substances meet the Article 57 criteria for addition to the Candidate List, e.g. if they are category 1A or 1B reproductive toxins. Details on the substances and typical uses are as follows:

  • 2-benzyl-2-dimethylamino-4′-morpholinobutyrophenone (CAS 119313-12-1): This substance is used as a photoinitiator added to UV curable inks, toners, adhesives, resins, paints and other coatings. It may also be used in fillers and adhesives. It is used in the manufacture of many products including electronic equipment. This substance is added typically at 0.5 to 5% of the cured material which may be a coating on an article or printed ink and so the concentration in simple articles (as defined by REACH) could be less than 0.1% by weight. However, when it is used as a thicker section of cured polymer the concentration it is more likely to exceed 0.1% of the article.
  • 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one (CAS 71868-10-5): This is a photoinitiator added to UV curable inks, toners, lacquers, paints and resins. It may also be used in solder masks and etch resists in glass fibre composites. It is used at similar concentrations to 2-benzyl-2-dimethylamino-4′-morpholinobutyrophenone so may occur at <0.1% in thinly coated articles, but when used as a thicker section it is more likely to exceed 0.1% of the article.
  • Diisohexyl phthalate (CAS 71850-09-4): This is another dialkylphthalate that has been added to the Candidate List. Dihexyl phthalate is already listed. This substance is a plasticiser so may occur in flexible polymers and rubbers, inks, lacquers and sealants. It is also reported to be used in vehicle steering fluids and in auto transmission lubricants.
  • Perfluorobutane sulfonic acid (PFBS) and its salts (No unique CAS number as it is group of substances): These substances are used as water soluble surfactants and in stain and water resistant coatings (including as a substitute for perfluoroctyl sulphonate – PFOS, which is now banned in many countries).

If these substances are determined to be eligible to be added to the Candidate List, they could be added with the next update to the Candidate list due in January 2020.

Inclusion of Bisphenol A in REACH Candidate List – as a Reproductive Toxin

Overview

Bisphenol A is a substance which is mainly used as an intermediate in the manufacture of polymers. It is also used for non-intermediate purposes for the manufacture of thermal paper. On 19 July 2016, the Commission adopted a regulation1 under which Bisphenol A is classified as toxic for reproduction.

In accordance with the relevant procedure, the French National Security Agency for Food, Environmental and Occupational Health and Safety presented the European Chemicals Agency (ECHA) with a dossier concerning Bisphenol A in which it is stated that that substance is used for non-intermediate purposes but that it is not that substance’s sole use. ECHA’s Member State Committee, after having met, unanimously decided to identify Bisphenol A as a substance of very high concern meeting the criteria set out in Article 57(c) of the REACH Regulation2. On 4 January 2017, the Executive Director of ECHA adopted a decision whereby Bisphenol A was included in the list of substances identified for eventual inclusion in the list of substances subject to authorisation referred to in Article 59(1) of the REACH Regulation.

The association, PlasticsEurope, represents the interests of manufacturers and importers of plastic products in the European Union and, inter alia, four companies active in placing Bisphenol A on the market. According to that association, in adopting the contested decision of 4 January 2017 without explicitly excluding intermediate uses from the inclusion of Bisphenol A in the candidate list of substances, ECHA infringed the REACH Regulation. It complains that ECHA breached the principle of proportionality and committed a manifest error of assessment by failing to take into consideration information on the intermediate uses of Bisphenol A. It therefore brought an action for annulment before the General Court against the decision of the Executive Director of ECHA of 4 January 2017.

In today’s judgment, the General Court notes that a substance used as on-site isolated intermediate or as a transported isolated intermediate is not automatically exempted from all the provisions of the REACH Regulation. Such a substance does not, therefore, escape the identification procedure provided for in that regulation. The exemption laid down in Article 2(8)(b) of the REACH Regulation concerns only the authorisation procedure. By contrast, the regulation does not preclude a substance from being capable of being identified as being of very high concern, even though it is used merely as an on-site or transported isolated intermediate.

The General Court notes, furthermore, that nothing obliged ECHA to insert, in the ‘candidate list of substances’, an explicit reference to the fact that intermediate uses were not covered by the inclusion of Bisphenol A in that list.

The General Court points out that one of the objectives of the candidate list of substances is the establishment of information sharing obligations in respect of substances of very high concern within the supply chain and with consumers. The identification of a substance as a substance of very high concern serves to improve information for the public and professionals as to the risks and dangers incurred. The General Court therefore considers that the contested decision is consistent with the objective of sharing information on substances of very high concern within the supply chain and with consumers. It finds that the legal effects of that decision do not go beyond what is appropriate and necessary to achieve that aim.

Lastly, the General Court considers that the use of a substance as an intermediate is not relevant, since the information relating to that use does not concern the intrinsic properties of that substance whereas the identification and inclusion of a substance in the candidate list of substances are carried out solely on account of the intrinsic properties of a substance and not on account of the uses of that substance.

The General Court therefore dismisses the action in its entirety

NOTE: An appeal, limited to points of law only, may be brought before the Court of Justice against the decision of the General Court within two months and 10 days of notification of the decision. The appeal will not proceed unless the Court first decides that it should be allowed to do so. Accordingly, it must be accompanied by a request that the appeal be allowed to proceed, setting out the issue(s) raised by the appeal that is/are significant with respect to the unity, consistency or development of EU law.

NOTE: An action for annulment seeks the annulment of acts of the institutions of the European Union that are contrary to European Union law. The Member States, the European institutions and individuals may, under certain conditions, bring an action for annulment before the Court of Justice or the General Court. If the action is well founded, the act is annulled. The institution concerned must fill any legal vacuum created by the annulment of the act.

EU: Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU – Proposed Amendment – (on exemption for lead in solders and termination finishes used in certain hand-held combustion engines) Draft Directive, August 2019

Overview

“In Annex III to Directive 2011/65/EU, entry 41 is replaced by the following:

41. Lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems, which for technical reasons must be mounted directly on or in the crankcase or cylinder of handheld combustion engines (classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the European Parliament and of the Council *)

Applies to all categories and expires on:

  • [the last day of the 24th month after the publication of this Delegated Directive in the Official Journal] for categories 1 to 7, 10 and 11;
  • 21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;
  • 21 July 2023 for category 8 in vitro diagnostic medical devices;
  • 21 July 2024 for category 9 industrial monitoring and control instruments.”

EU: How to Comply with NMP (1-methyl2-pyrrolidone) Restriction, Guidance Document, July 2019

A document released by ECHA intends to help those who use 1-Methyl-2-pyrrolidone (NMP) or mixtures containing NMP (C ≥ 0.3%) , to comply with the restriction requirements under the REACH Regulation. Moreover this guidance may help the authorities to understand what is expected and evaluate the compliance at a site.

NMP has a harmonised classification as toxic to / for reproduction (reproductive toxicant category 1B) and is also a respiratory, skin and eye irritant. In Europe, NMP is subject to REACH Annex XVII restriction 71. If you have to use NMP in your workplace, you need to protect anyone that could be exposed to it. This guideline is intended to help you understand what you need to do to comply with the provisions of this restriction in its own right but also against the background of your existing occupational safety and health (OSH) obligations.

The general approach described in this guideline can be applied to other aprotic solvents similar to NMP (such as DMF and DMAC), if similar REACH restrictions are introduced for other aprotic solvents. Some elements of the guideline are NMP specific (e.g. good practice examples, monitoring methods, description of uses etc.) and therefore may not be directly applicable to other substances.”

A new guideline is available for industrial users of 1-methyl-2-pyrrolidone (NMP) to help them comply with the substance’s restriction requirements. The guideline is needed because this is the first restriction of its kind that is based on Derived no Effect Levels (DNEL).

NMP is used as a solvent or surface deposition medium during manufacturing and is therefore a critical substance for various industries producing batteries, semiconductors, fibres, pharmaceuticals and wire coatings. NMP users in these sectors will have to comply with the restriction by 9 May 2020. For NMP used in wire coatings, the deadline is 9 May 2024.

In close cooperation with stakeholders, ECHA has prepared the guideline to help companies, including SMEs, to manage the risks when using NMP at industrial sites. NMP is a reproductive toxicant (may damage the unborn child), it causes serious eye and skin irritation and it may cause respiratory irritation. Several consultations and round table workshops have been organised to identify good practice and find illustrative examples on how users of NMP can control exposure to NMP and comply with the restriction.

The general approach described in this guideline can also be applied to other aprotic solvents similar to NMP, such as DMF and DMAC, if similar REACH restrictions are introduced for other aprotic solvents at a later stage.

The document can be found at this link.

EU: Towards a Sustainable Chemicals Strategy of the Union, Policy Document, June 2019

Overview

On June 26, 2019 the Council adopted conclusions on chemicals which offer political guidance on the development of a sustainable EU chemicals policy strategy. The conclusions address the topics of REACH, endocrine disruptors, nanomaterials and pharmaceuticals.

In its conclusions, the Council underlines the need to protect human health and the environment through the sound management of chemicals. It also highlights the need to improve and mainstream the chemical risk assessment and management of chemicals across EU legislation in order to increase the coherence and effectiveness of EU chemicals-related legislation.

The conclusions highlight the need to develop a relevant mechanism for coordinating the protection of vulnerable groups such as children and pregnant and breastfeeding women. This should include the introduction of consistent risk management requirements into relevant EU legislation on substances of concern, including neurotoxins and endocrine disruptors.

Ministers call for the promotion of green and sustainable chemistry and non-chemical alternatives, and for the stimulation of research and service-based business models in this regard.

The Council underlines the need to support small and medium-sized enterprises in their efforts to replace substances of concern and stresses the right to information in order to enable consumers to make informed choices.

The Council also supports the development and implementation of an early warning system at EU level for identifying new, emerging chemical risks that will allow for appropriate action to be taken to protect human health and the environment.

The Council urges the Commission to develop, without further delay, a Union strategy for a non-toxic environment, that proposes clear objectives for a comprehensive long-term sustainable EU chemicals policy. It calls upon the Commission to include in its proposal for an 8th Environment Action Programme commitments to implement the follow-up measures to the Union strategy for a non-toxic environment and to address forward looking chemical related challenges. The Council also highlights the need for sustainable financing and resourcing of the European Chemicals Agency and calls for its involvement in other legislative areas.

The conclusions also address the following topics:

  • Pharmaceuticals: The Council stresses the importance to accelerate concrete and ambitious actions to reduce the risk from pharmaceuticals and their residues to the environment.
  • REACH: The Council calls upon the Commission and ECHA to develop by December 2019 an action plan on dossier compliance for REACH. The Council also stresses the importance of improving the REACH authorisation and restriction procedures.
  • Nanomaterials: The Council requests the Commission to extend ECHA’s mandate to collect and make available research data on the characterization, the hazard and potential exposure of nanoforms of substances that were so far not registered under REACH because their yearly tonnage is below the threshold of 1 tonne/year and to regularly ask ECHA to evaluate the performance and the impact of the EU-Observatory on Nanomaterials which was launched in 2017.
  • Endocrine disruptors: The Council urges the Commission to ensure a high level of protection of human health and the environment by minimising exposure to endocrine disruptors and by stimulating substitution by safer chemicals, as far as technically and practically possible, and to provide, without undue delay, an action plan with clear and concrete measures and an ambitious timeline for doing so.

Japan Regulation for NRMM or Non-Road Mobile Machinery

For AIAG suppliers who may provide parts into both markets, the NRMM and in-general equipment market will be heating up as they begin to fall under RoHS (Restrictions on Hazardous Substances) requirements. RoHS Annex IV has a Category 11 product type which is ‘everything else.’

Overview

Enacted in 2005, this Law aims to reduce emissions from non-road special motor vehicles and thereby protect the health of the people from air pollution and preserve their living environment, through the setting of technical standards for specified engines as well as non-road special motor vehicles and imposing necessary regulations on the use of non-road special motor vehicles, among other measures.

Non-road special motor vehicles are defined in Paragraph 2 of Article 2 of Road Vehicles Act (Act No. 185 of 1951), and emissions from non-road special motor vehicles refers to substances such as carbon monoxide, hydrocarbon and lead.

This law provides for obligations of manufacturers and importers of specified engines and non-road special motor vehicles such as conformity, marking and notification etc.

The notified business operators shall conform to technical standards for non-road special motor vehicles in respect to the type of notified non-road special motor vehicle concerned. The businesses must also compile an inspection record and preserve it pursuant to the provision of the Ordinance of the competent ministry.

Furthermore, when the notified business operator has complied with his duty as prescribed in this law, he/she may affix an indication as specified in the Ordinance of the competent ministry on the type of notified non-road special motor vehicle concerned.

This law entered into force on 1 April 2006.

China: Compulsory Certification of Motor Vehicles, Implementation Rules CNCA C11-01, 2014

This rule applies to motor vehicles of categories M, N and trailers of category O (including integrated or unintegrated) operating on highway and road in China.

Motor vehicles operating on railway, tractors for agriculture and forestry, all construction machinery and other motor vehicles not operating on road and chassis of category 3 are excluded.

This standard is written for the whole vehicle and the tests required to obtain certification. There are also standards for numerous individual automotive components. Certifying the individual components according to the CNCA automotive regulations is the preferred solution; otherwise, service parts imported into China may be detained by Chinese customs. In addition, according to the relevant CNCA automotive norms, these components cannot be marked with the CCC mark.

EPA Prioritization of 20 chemicals for TSCA

As required under the Toxic Substances Control Act (TSCA) and related implementing regulations, this proposed list initiates the prioritization process for 20 chemical substances as candidates for designation as High Priority Substances for risk evaluation and 20 chemical substances as candidates for designation as Low Priority Substances for risk evaluation. This document provides the identity of the chemical substances being initiated for prioritization, a general explanation of why the Agency chose these chemical substances and information on the data sources that EPA plans to use to support the designation.

EPA is providing a 90-day comment period (until June 19, 2019) during which interested persons may submit relevant information on these chemical substances.

Under the amended TSCA statute (section 6(b)(1)(B)) and implementing regulations (40 CFR 702.3), a High Priority Substance is defined as a chemical substance that EPA determines, without consideration of costs or other non-risk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant by EPA. A Low Priority Substance is described as a chemical that EPA concludes, based on information sufficient to establish, without consideration of costs or other non-risk factors, does not meet the statutory criteria for designation as a High Priority Substance.

The EPA text from the Federal Register can be found at this link.

Public Consultation Launched on Chemical, Product and Waste Legislation

ACEA, CLEPA,  DIGITALEUROPE, ASD and other industry groups have issued a joint letter asking the EU Commission to allow stakeholder input on the proposed new Waste Frame Directive database as it’s being created.  They believe many benefits could be had from learning from IMDS and other formats being used in complex durable goods supply chains.  They also asked the Commission to take the below released report into consideration.  In the context of the Circular Economy Package, adopted in January 2018, the European Comm launched an Open Public Consultation (OPC) focused on options to address the interface between chemical, product and waste legislation, which ran from 23 July to 29 October 2018.

The questionnaire was divided in two parts: Part A aimed at gathering information on the company or organization represented by the respondent; Part B was organized based on the four main issues identified by the European Commission in the Communication and Staff Working Document on the interface that were published earlier in 2018. The questionnaire identified a number of challenges for each issue and posed questions (both multiple choice and open questions) aimed at collecting detailed information on specific topics.

This Public Consultation received 461 valid responses. 40 ad hoc contributions in the form of position papers were received separately. The replies were sorted and analyzed by category of stakeholder. Stakeholders were categorized as follows: Academic or Research Institutes/Educational Institutions (Academia); Non-governmental organizations (NGOs); Governments or public authorities (Governments); Other ; Businesses; and Industry or Trade Associations (Industries and Trade Associations). In addition, categories such as Businesses and Industries and Trade Associations included a versatile profile of respondents (recyclers, manufacturers, importers, etc.)

More information can be found at the Europa link here.

EU REACH

On 12 February 2019, the Commission joint Committee established under the REACH regulation, opened discussion on a proposal to amend Annex XIV of the regulation in order to list 12 additional new SVHC.

The proposal, which is based on ECHA 5th, 7th and 8th recommendations, will expand the REACH authorization list to 55 substances with sunset date up to 54 months after date of entry into force of the amended regulation.