The California Office of Environmental Health Hazard Assessment (OEHHA) added four substances to the Proposition 65 list of substances known to the State of California to cause cancer. The Proposition 65 notice of the four new substances is posted on the OEHHA website[1].

The substances are:

• tetrahydrofuran (CAS No. 109-99-9),
• 2-ethylhexyl acrylate (CAS No. 103-11-7),
• methyl acrylate (CAS No. 96-33-3), and
• trimethylolpropane triacrylate, technical grade.

The listing came into effect on December 17, 2021. Proposition 65 provides for a one-year transition period, therefore products that are an exposure risk for any of these substances will have until December 17, 2022 to meet the warning label requirements.

[1] OEHHA prop 65 notice, https://oehha.ca.gov/proposition-65/crnr/notice-interested-parties-chemicals-listed-effective-december-17-2021-known

The U.S. EPA has proposed a rule that will extend the compliance deadline restricting PIP (3:1) in articles until October 31, 2024 and opens a 60 day public consultation period.

The summary in the proposed rule provides a convenient synopsis:

The Environmental Protection Agency (EPA) is proposing to amend the regulations applicable to phenol, isopropylated phosphate (3:1) (PIP (3:1)) promulgated under the Toxic Substances Control Act (TSCA). Specifically, EPA is proposing to extend the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles until October 31, 2024, along with the associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles. EPA is also announcing its intention to commence a new rulemaking effort on PIP (3:1) and four other persistent, bioaccumulative, and toxic (PBT) chemicals that have been regulated under TSCA section 6(h). EPA is anticipating issuing a proposal to this end in 2023.

The proposed rule (which is expected to be approved) will provide EEE manufacturers who import manufactured goods (articles) into the U.S. a reprieve until 2024.

In the proposed rule, the EPA states that some companies and industry groups have indicated a need for even more time (beyond 2024) to comply. The EPA has invited those manufacturers to provided detailed technical information on the applications where PIP (3:1) is needed and the specific technical efforts they have undertaken to substitute.  The EPA has drawn an analogy to the level of technical detail that the EEE industry provides to the European commission to justify specific RoHS exemptions.

The docket id of the proposed rule is EPA-HQ-OPPT-2021-0598-0001 and is available from the regulation.gov website[1].

[1] EPA proposed rule on PIP (3:1), https://www.regulations.gov/document/EPA-HQ-OPPT-2021-0598-0001

On September 3, 2021, the U.S. EPA posted a pre-publication federal register notice that will extend the compliance deadline restricting Phenol, isopropylated phosphate (3:1) (PIP (3:1)) in articles to March 8, 2022, instead of the current date of March 8, 2021.  EPA will also be opening a public consultation on possible further extensions where justified.   The consultation will provide stakeholders an opportunity for “describing specific information that the Agency would need to justify any further compliance deadline extensions.”

The EPA also posted a summary on the current situation on their website[1], and a page with links to relevant rules on all five PBT substance restrictions[2]. A copy of the pre-publication is available for download[3].     A summary of the change is excerpted below:

Note:  The prepublication notice is not an official rule until it is finalized and published in the federal register (this takes time), but it has been signed by the EPA administrator. The notice signals that the EPA intends to provide manufacturers, importers and distributers at least six additional months to collect supply chain information for PIP (3:1) content, take appropriate action, and to respond to the public consultation if a further extension is justified.

Background information provided in the notice indicates that EPA started the risk assessment seven years ago, published the draft rule in 2019, and has conducted multiple public consultations.  There was no indication from EEE manufacturers that PIP (3:1) was being used or that there would be a challenge to the industry with the restriction. EPA was under a strict timeline specified in TSCA to assess and restrict PIP (3:1) given its PBT properties.

Never-the-less, the EPA has flexibility to provide an exemption for applications that are of an essential nature (e.g. national defense and public health), but the application needs to be specific and justified.

During the March-May 2021 consultation, the information that the EPA received from industry was very general and not specific enough to grant a longer extension. Furthermore, consumer and environmental groups provided comments that the industry has already had seven years to prepare and that no additional extension should be provided. Therefore, the EPA in their next consultation will be specific on exactly what information they require to justify an extension.

Discussion of Impact on EEE Manufacturers

The one-year extension is helpful but challenges remain with collecting information from supply chains and redesigning products containing PIP (3:1) – especially products with long design cycles or qualification times. The EEE industry associations had requested a blanket four-year extension to the PIP (3:1) restrictions so the total one-year extension falls significantly short.  EPA realizes that some product categories have long design and qualification cycles (e.g. medical equipment) or use a supply chain that is focused on a sector that already has an exemption (e.g. heavy equipment using the automotive supply chain) and that the timeline for these products needs to be reconsidered.  But each product category needs to be justified.

[1] EPA summary of PIP (3:1) events, https://www.epa.gov/chemicals-under-tsca/epa-announces-plan-new-rulemaking-pbt-chemicals-extends-existing-compliance

[2] EPA links to PBT rules, https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/persistent-bioaccumulative-and-toxic-pbt-chemicals

[3] PIP (3:1) prepublication rule, https://www.epa.gov/system/files/documents/2021-09/prepubcopy_frl-6015.5-03-ocspp_tsca-pbt_pip31_compliance-date_finalrule_20210903_admin_0.pdf

On September 5, 2021, ECHA posted a stakeholder consultation on four substances that are under consideration as SVHCs on the REACH Candidate List. The four potential SVHCs are listed in Table 1. These substances are likely to be added to the REACH Candidate List during the next update in December/January.  The IEC 62474 Validation Team is currently reviewing the substances for potential use in EEE.

Table 1: REACH SVHC Consultation List

Germany, Denmark, the Netherlands, Norway, and Sweden submitted on 15 July 2021 their intent to restrict PFAS. Proposals are expected to be submitted to ECHA by 15 July 2022 and will restrict the manufacture and placing on the market of PFAS.

The five countries are open for stakeholder comments until 19 September 2021, the questionnaire is accessible from the REACH-CLP-Biozid Helpdesk3.

The ECHA website provides the scope of the incoming restrictions, “any chemical with at least one perfluorinated methyl group (-CF3) or at least one perfluorinated methylene group (-CF2-), –), including branched fluoroalkyl groups and substances containing ether linkages, fluoropolymers and side chain fluorinated polymers.”

ECHA has indicated their intention to submit a proposal restricting Medium-chain chlorinated paraffins (MCCP). MCCP were added to the REACH Candidate List this past July and are used as a flame retardant and /or plasticizer in some EEE components.  The IEC 62474 DSL lists the typical EEE applications / uses as: “Flame retardant and / or plasticizer in PVC and rubber, paints and coatings, adhesives and sealants, textiles and fabric”

ECHA intends to submit the restriction proposal by July 26, 2022 and has suggested the scope of restriction as “Restricting the manufacture, use or placing on the market of MCCP”.

MCCP restriction in EEE is also expected in the next update to the RoHS Directive (RoHS 3) and the UK has submitted a proposal for listing MCCP in the Annexes to the Stockholm Convention on Persistent Organic Pollutants (POPs).

In technical terms, MCCP is a substance group of UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17. ECHA has provide five member substances in the group (see Table 1).

Table 1: Members of MCCP Substance Group

The registry of restriction intentions is available on the ECHA website[1].

[1] Registry of restriction intentions, https://echa.europa.eu/registry-of-restriction-intentions

The European Commission has published Commission Regulation (EU) 2021/1297 of 4 August 2021[1] restricting certain perfluorocarboxylic acids (C9-C14 PFCAs)– a subgroup of per- and polyfluoroalkyl substances (PFAS). The restriction was added to REACH Annex XVII (entry #68). PFCAs cannot be placed on the market or used in most applications from 23 February 2023 onwards. Some uses have been granted longer transition periods.

The identification of the substances and the description of the restriction are both complex. Given the very low threshold for PFCAs, the overall intention of the restriction is to eliminate the use of PFCAs, including as a substitute for PFOAs.

The details of the restriction may be found on the ECHA website[2] and is also excerpted below.

Identification of the substance

Linear and branched perfluorocarboxylic acids of the formula CnF2n +1-C(= O)OH where n = 8, 9, 10, 11, 12, or 13 (C9-C14 PFCAs),

including their salts, and any combinations thereof;

Any C9-C14 PFCA-related substance having a perfluoro group with the formula CnF2n +1- directly attached to another carbon atom, where n = 8, 9, 10, 11, 12, or 13, including their salts and any combinations thereof;

Any C9-C14 PFCA-related substance having a perfluoro group with the formula CnF2n +1- that it is not directly attached to another carbon atom, where n = 9, 10, 11, 12, 13 or 14 as one of the structural elements, including their salts and any combinations thereof.

The following substances are excluded from this designation

– CnF2n +1-X, where X = F, Cl, or Br

where n = 9, 10, 11, 12, 13 or 14, including any combinations thereof,

– CnF2n +1-C(= O)OX’ where n> 13 and X’=any group, including salts.

Conditions of Restriction

1. Shall not be manufactured, or placed on the market as substances on their own from 25 February 2023.
2. Shall not, from 25 February 2023, be used in, or placed on the market in:

(a) another substance, as a constituent;

(b) a mixture;

(c) an article,

except if the concentration in the substance, the mixture, or the article is below 25 ppb for the sum of C9-C14 PFCAs and their salts or 260 ppb for the sum of C9-C14 PFCA-related substances.

3. By way of derogation to paragraph 2, the concentration limit shall be 10 ppm for the sum of C9-C14 PFCAs, their salts and C9-C14 PFCA related substances, where they are present in a substance to be used as a transported isolated intermediate, provided that the conditions in points (a) to (f) of Article 18(4) of this Regulation are met for the manufacturing of fluorochemicals with a perfluoro carbon chain length equal to or shorter than 6 atoms. The Commission shall review this limit no later than 25 August 2023.
4. Paragraph 2 shall apply from 4 July 2023 to:

(i) textiles for oil- and water-repellency for the protection of workers from dangerous liquids that comprise risks to their health and safety;

(ii) the manufacture of polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF) for the production of:

– high performance, corrosion resistant gas filter membranes, water filter membranes and membranes for medical textiles;

– industrial waste heat exchanger equipment;

– industrial sealants capable of preventing leakage of volatile organic compounds and PM 2,5 particulates

5. By way of derogation to paragraph 2, the use of C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances shall be allowed until 4 July 2025 for:

(i) photolithography or etch processes in semiconductor manufacturing;

(ii) photographic coatings applied to films;

(iii) invasive and implantable medical devices;

(iv) fire-fighting foam for liquid fuel vapour suppression and liquid fuel fire (Class B fires) already installed in systems, including both mobile and fixed systems, subject to the following conditions:

– fire-fighting foam that contains or may contain C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances shall not be used for training;

– fire-fighting foam that contains or may contain C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances shall not be used for testing unless all releases are contained;

– from 1 January 2023, uses of fire-fighting foam that contains or may contain C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances shall only be allowed to sites where all releases can be contained;

– fire-fighting foam stockpiles that contain or may contain C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances shall be managed in accordance with Article 5 of Regulation (EU) 2019/1021.

6. Paragraph 2(c) shall not apply to articles placed on the market before 25 February 2023.
7. Paragraph 2 shall not apply to the can coating for pressurised metered-dose inhalers until 25 August 2028.
8. Paragraph 2 (c) shall apply from 31 December 2023 to:

(a) semiconductors on their own;

[1] EU regulation, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R1297&_cldee=d2phZ2VyQGdvZWNkLmNvbQ%3d%3d&recipientid=lead-161102cfc0e0e71180fa005056952b31-892892d390e34211ab5d022fa9bde5bd&esid=5af5cdcb-0500-ec11-812e-005056b9310e

[2] ECHA substance restricted under REACH, https://echa.europa.eu/substances-restricted-under-reach

A representative of DEFRA (Department of Environment, Food, and Rural Affairs) spoke about the implementation of RoHS in Great Britain and Northern Ireland. Some minor changes have occurred with the implementation of UK RoHS. Distributors in the UK who were selling imported products in the UK (imported via an EU country) are now importers instead of distributors. In addition, in selling from the US to Northern Ireland, products must meet EU requirements (the UKCA mark is not required); from NI qualifying Northern Ireland goods[1] can enter GB. Inversely, NI businesses importing goods from GB will need to conform to EU importer obligations. Exemption decisions in the EU will automatically comply in NI.

UK RoHS currently maintains the same restrictions (on 10 substances[2]) as EU RoHS. These restrictions have been applicable for most equipment since 22 July 2019 — the exception being medical devices and monitoring & control instruments for which they will enter into force at the end of 2021 in the UK (22 July 2021 in the EU).

Compliance Marking (CE and UKCA)

The representative said that the UKCA mark does not need to be on products on the market until the beginning of 2023, in the interim they must be accompanied by paperwork demonstrating proof of compliance.

If CE applications were made to the EU before the end of the Implementation period, there is no need to re-apply with DEFRA; the UK has put in a fast-track process to review the EU’s decision and decide whether it will adopt the commission’s decision.

Packaging WEEE and Batteries Reviews

Consultations on WEEE and batteries will occur before end of 2021. DEFRA highlighted that significant changes should be expected in these areas as of 2024, which includes new obligations on online marketplaces; reforms on household and non-household obligations; and emphasis on measures to stimulate the circular economy and incentivise eco-design.

Compliance with UK RoHS

A representative of OPSS said that they have tested 366 targeted products for RoHS compliance ─ 262 of which failed. The failures of the products were caused by issues with:

• Lead (128/262)
• Labelling (90/262)
• Phtalates – DEHP, BDP, DBP & DIBP (52/262)
• Hexavalent chromium (11/262)
• Cadmium (4/262)
• Mercury & PBB/PBDE (0/262)

Tests were performed by accredited test houses in the UK.

[1] Qualifying NI goods, https://www.gov.uk/guidance/moving-qualifying-goods-from-northern-ireland-to-the-rest-of-the-uk

[2] Using the UKCA Mark, https://www.gov.uk/guidance/rohs-compliance-and-guidance

On 31 December 2020 all restrictions, substances on the Candidate List, and substances on the Authorisation List that were in force were carried over from EU REACH to UK REACH. Priorities will be identified annually for the UK REACH WORK Program, as a coordinated effort by UK, Welsh, and Scottish governments. The work that the EA (Environmental Agency) and HSE (Health and Safety Executive) do each year will be articulated in the ‘UK REACH Work Program’ ─ a document, the first of which is now published on the HSE website.

Note: SCIP does not apply to the UK ─ there exists a UK SVHC list (Annexe XIV list ─ on the HSE website); DEFRA is attempting to determine how to best address substance information in the future.

HSE (and EA) are preparing restriction dossiers on the use and/or sale of lead ammunition, and on substances in tattoo inks and in permanent makeup ─ a restriction will be introduced if evidence shows an unacceptable risk to human health and the environment, and after a public consultation. EA and HSE are investigating the risks posed by PFAS through RMOA (Regulatory Management Options Analysis).UK – UK RoHS (and Compliance of the Northern Ireland Protocol)

The European Chemical Agency (ECHA) added eight additional substances to the EU REACH Candidate List on July 8, 2021. The new Substance of Very High Concern (SVHC) entries are listed in Table 1. There is now a total of 219 SVHCs on the REACH Candidate List.

The IEC 62474 Validation Team has reviewed the substances for potential uses in EEE – SVHCs that were identified by the IEC 62474 Validation Team as possible EEE constituents are shown with their typical EEE applications. The IEC 62474 DSL was updated to include the three SVHCs on July 18, 2021.

The full REACH Candidate List is available from the ECHA website[1]:

Table 1: SVHCs added to REACH Candidate List (July 2021)

Note from ECHA: due to a technical error, the EC entry 251-823-9, EC name: tetrahydro-4-methylphthalic anhydride was mistakenly associated to an earlier Candidate List entry Hexahydromethylphthalic anhydride [including cis- and trans- stereo isomeric forms and all possible combinations of the isomers]. The associated substance tetrahydro-4-methylphthalic anhydride has now been removed from the Candidate List. The substance infocard and brief profile are being updated accordingly. We apologise for any inconvenience this may have caused.

[1] REACH Candidate List, http://echa.europa.eu/candidate-list-table