The Weekly Pulse: 18 - 22 March, 2024

Your Weekly Source for Global Regulatory Insights

This Week's Trending Sources in C2P

• EU: Packaging and Packaging Waste, Draft Regulation, November 2022 (updated with revised proposed text)?
• EU: Waste Shipments, Draft Regulation, November 2021 (updated with revised proposed text)?
• EU: Liability for Defective Products, Draft Directive, September 2022 (updated with revised proposed text)

What are our Content Team talking about?

UK DBT Confirms Flexible Approach to Product Marking

By Joyce Costello

Advisors from the UK's Department of Trade this afternoon discussed?matters regarding the UK's approach to product marking.

With regard to the continued CE recognition, the Department announced that the current flexible labelling requirement will?be made permanent. In practice this will mean the continued recognition of current EU markings and?declaration of conformity?based on?21 product regulations, 18 of which are owned by Department of Trade, and cover most products coming within the EU's harmonized regime. The Department emphasized that not all product regulations are?included - a tailored approach is being taken by the?UK?government, with?medical devices and?construction products having?their own arrangements.

The same declaration of conformity used to market goods in accordance with EU regulatory requirements will therefore also be accepted in the UK, provided that it is in English, lists the regulations met (of the 21) and indicates how these have been met.

The Department also announced that?products certified and marked under the EU's eco-design?and RoHS rules?may also continue to be placed on the market in the UK, without the need to meet further requirements.

The proposed legislation allowing the extended recognition of CE marking is expected to be laid before Parliament this Spring, before?coming into effect later this year.

What about UKCA?

Businesses who wish to assess products in accordance with UK requirements and use the UKCA label can continue to do so, as this remains a valid and robust approach. The Government is developing a fast-track UKCA optional process?for?products placed in England, Wales and Scotland?to maximize choice, in allowing manufacturers to use the UKCA mark for either UK or EU requirements.

Legislation is expected later in the year on the new option for digital labelling, to be applicable to UKCA only.

Further detailed guidance on the above, including the list of recognized EU product regulations, is available here.

What are out Knowledge Partners talking about?

RINA: EU REACH – Five More SVHCs Being Considered for Addition to the Authorization List

From Rina

The European Chemicals Agency (ECHA) announced on 7 th February 2024 that it is considering recommending five Substances of Very High Concern (SVHC) to be added the Authorization List (Annex XIV). As existing SVHCs since 2023, all have been subject to reporting and sometimes notification requirements where present in articles at >0.1%. However, addition to Annex XIV would introduce more onerous requirements which would affect availability in the supply chain. It is therefore instructive to consider where they might be found. The five substances and their uses are summarized below.

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1. Barium diboron tetraoxide (i) EC number 237-222-4, CAS number 13701-59-2: Also called barium borate, this substance is classified as toxic for reproduction, category 1B, where it may damage fertility and may damage the unborn child. It is used in paints and coatings and is added to adhesives (e.g. epoxy and acrylic types), paper products and plastics. It is used as a biocide, as a white pigment (e.g. in paints) with anti-corrosive properties and is also used as a UV stabiliser in PVC. It may also occur in ceramic dielectrics (for ceramic capacitors) where it has been used as a flux additive. It will occur at >0.1% in some articles, but usually <0.1% when it is used to paint articles or in articles bonded with a thin adhesive layer. Similarly structured borates that are already on the Authorisation List may use barium diboron tetraoxide as an alternative, hence why it has been added; to avoid use as a regrettable substitute.
2. Bis(2-ethylhexyl) tetrabromophthalate (covering any of the individual isomers and/or combinations thereof) (ii)?EC number –, CAS number –: This group of substances are classified as vPvB (very persistent and very bioaccumulative). Registered uses of these substances include use in the production of rubber articles, use of plastics, masterbatch or compound in extrusion applications at industrial sites, use as flame retardants and plasticizers in vinyl products (e.g. PVC). It is used as a flame retardant in wire and cable insulation, carpet backing, fabrics, wall coverings, adhesives, coatings and polyurethane foam, so can be present in articles >0.1%. According to registrations, the substance is used in coated and painted articles and release of the substance from these articles cannot be excluded.
3. Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (TPO)(iii) EC number 278-355-8, CAS number 75980-60-8: This substance is classified as toxic for reproduction, category 1B, where it may damage fertility and may damage the unborn child. Registered uses of the substance include use in formulation of inks, toners, coatings and adhesives, use as photoinitiator in UV-curable inks, coatings and adhesives, as process regulator for polymerization processes in production of resins, rubbers, polymers and uses by professional workers in inks, coatings and adhesives. TPO should not be present in articles above the 0.1% w/w limit and should only be found in trace amounts. Additionally, this recommendation is a priority due to its similar structure to substances already previously recommended as additions to Annex XIV.
4. Melamine(iv) EC number 203-615-4, CAS number 108-78-1: This substance, also known as 1,3,5-triazine-2,4,6-triamine, is classified as having probable serious effects to the environment and human health. Registered uses of the substance include uses at industrial sites as an additive in foams and coatings, use in resins and uses by professional workers as an additive in intumescent coatings. Additionally, Melamine is used in plastic, metal, leather, textile, and wood articles and releases of the substance from these articles cannot be excluded. Melamine will not occur in articles at >0.1% due to its use as a process chemical.
5. S-(tricyclo[5.2.1.0-(2,6)]deca-3-en-8(or 9)-yl) O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate(v) EC number 401-850-9, CAS number 255881-94-8: This substance is classified as a persistent bioaccumulative and toxic (PBT) substance. Registered uses of the substance include uses at industrial sites as lubricants and greases and/or uses by professional workers as lubricants and greases in vehicles or machinery.

Next steps

At present ECHA is seeking information on the uses of these substances, the structure and complexity of the supply chains in which they are present, and possible exemptions. In regard to the latter, a reasoned case with evidence would need to be put forward. The consultation is open until 7 May 2024.

Substances on Annex XIV may not be manufactured or used (as substances or in mixtures) in the EU after a defined sunset date unless prior authorization has been granted. Any authorization granted is specific to the applicant(s) and their supply chains with certain limitations (unlike RoHS exemptions which can be used by any party). Applying for authorization once a substance is in on Annex XIV is long winded and expensive therefore engagement with the present consultation (and the registrants of the substances concerned to make them aware of your use) is advisable if you consider you might be affected. Note that authorization does not apply to articles - so any article made outside the EU using a substance on Annex XIV and then imported is not directly affected. However, addition to Annex XIV may lead to a move away from manufacture and availability of the substance in other markets.

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What are our Clients asking about?

"Are there any updates and assessment that the EU agreed on earlier this month on CSDDD implementation?"

Answered by Celia Le Lievre

The draft CSDDD is still in the process of being approved by the EU Parliament. Therefore, the directive hasn't been published or implemented yet. There have been a number of updates concerning the CSDDD. Our most recent update in C2P relates to the approval of the compromise text of the CSDDD by the Committee of Permanent Representatives?(COREPER) on 15 March 2024.

Updates on the CSDDD have been shared by European Officials on LinkedIn and are summarized in the compromise text presented by the Belgian Presidency on 13 March 2024. No official press release from the EU has been seen by C&R at present. The compromise text - as approved by the Committee of Permanent Representatives - can be found here.

The ambitions of the original Directive have been largely watered-down. The revised proposal significantly reduces the number of EU and non-EU companies in scope. The scope now only includes companies with 1000 employees (compare to 500 employees) and a turnover of at least EUR 450 million (compared to EUR 150 million).

Despite the above set-back, the compromise text has been approved this morning by the Legal Affairs Committee (JURI) of the EU Parliament. The revised directive now needs to be formally adopted in the next plenary session of the EU Parliament, which will take place in April 2024. Should the EU Parliament adopt its position on first reading, the EU Council would approve the EU Parliament's position and the Act would be adopted into law.

Updates on the CSDDD can be found in C2P under the following source: "Corporate Sustainability Due Diligence (CSDDD), Draft Directive, February 2022".

The most recent updates can be found under the following headings:

1. The Legal Affairs Committee Approves Compromise Text of the Corporate Sustainability Due Diligence Directive (19 March 2024)
2. Vote on the Provisional Agreement on the Draft Corporate Sustainability Due Diligence Directive (19 March 2024)
3. Hot from the Press! EU Member States Finally Approve the Draft Corporate Sustainability Due Diligence Directive (15 March 2024)
4. A New Vote on the EU Draft Corporate Sustainability Due Diligence Directive Re-scheduled for March 15, 2023 (12 March 2024)

Why not join us on April 3rd for our webinar, “Reducing Manual Efforts in Regulatory Impact Assessment,” where we will explore strategies, tools, and best practices for reducing manual efforts in Regulatory Impact Assessment. Register here: https://www.complianceandrisks.com/webinar/reducing-manual-efforts-in-regulatory-impact-assessment/