OSOA, the EN IEC 63000 Revision, PFAS in Minnesota and the Flame Retardant Strategy

One Substance, One Assessment

Two years after the initial drafts were released, a trio of regulations were released in mid-December 2025 by the European Commission (EC) reattributing the task of chemical assessment from a variety of directives and regulations to the European Chemicals Agency (ECHA). As noted by the European Economic and Social Committee, “The ECHA will take over tasks that have so far been carried out by the Commission, supported by ad hoc committees and external consultants.” For the sake of this column, we’ll focus primarily on how this affects the RoHS Directive, 2011/65/EU.

The Commission has used several external and independent consultancies to help them primarily in these two areas:

• Evaluation of new exemption applications as well as exemption renewal applications
• Identification of potential additional substances to restrict

The most frequent of these, related to exemptions and primarily to renewal applications, has challenged the Commission since the first tranche of RoHS 2 renewal applications hit over a decade ago. It took years to get determinations on some of the 80 or so exemption renewal applications they received. They significantly underestimated the amount of concurrent work that a common date for exemption renewal across all exemptions would result in. Not that this solution directly addresses that problem, or some other critical problems. But it does address the meta-problem of coherence in assessing a single substance across multiple applications and regulations and managing that data in a single-source-of-truth database.

Regulation (EU) 2025/2455 establishes a common data platform on chemicals. The objectives of this regulation are

“… to ensure the efficient delivery of consistent hazard and risk assessments of chemicals where those assessments are required by Union legal acts, in order to achieve a high level of protection of human health and the environment, enable the development and use of safe and sustainable chemicals, ensure the proper functioning of the single market for chemicals, improve the Union’s citizens’ knowledge about and trust in the scientific basis for decisions taken under Union legal acts on chemicals and to contribute to the replacement and reduction of animal testing wherever possible.”

Obtaining this information today in a coherent and consistent form is challenging at best. This will serve as a single source of chemical information for use by EU regulatory agencies, including the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA), the European Medicines Agency (EMA) and the European Agency for Safety and Health at Work (EU-OSHA). As it will be publicly available, this should also be a boon to manufacturers who need more information about substances to help them determine whether they may be present in their products and, if they are, what potential toxicological issues may be present.

Directive (EU) 2025/2456 amends the RoHS Directive and reattributes scientific and technical tasks to the ECA. These tasks are specifically listed in Article 5 – which covers the granting, renewing and expiration of exemptions – and Article 6 – which covers the review and amendment of the list of restricted substances listed in Annex II. Historically – and until August 13, 2027 – the Commission has had to bring in external consultants to review and advise on these issues. While keeping the responsibility internal to the Commission by having the ECHA be responsible makes sense from the chemical perspective, ECHA may still need to hire external consultants to advise on application-related issues since they’re not experts on that aspect of the chemical substances’ use. I expect, however, that they will try to develop a degree of expertise internally at the JRC.

Interestingly, the new verbiage for Article 5 includes time limits on both ends of an exemption-related application. Time limits are defined at each step for the applicant, the Agency and both standard REACH Committees: the Committee for Socioeconomic Analysis and, where relevant, the Committee for Risk Assessment. An additional step is inserted where ECHA “shall communicate those draft opinions to the applicant and allow the applicant the opportunity to comment within 4 weeks of that communication” (section 4a(e)). Most interesting to me is the time limit of 9 months from the date of a completed application to the rendering of a draft opinion by the Commission. This step in the process has often been allowed to drag on, for years in some cases, particularly since the removal of the requirements that the Commission decide on an application for renewal no later than 6 months before the expiry date of the existing exemption (see Directive 2017/2102, Article 1(4)(c)). I’m not sure what has changed that makes them think this will be achievable now when it wasn’t before.

Finally (and less relevant to the electronics industry), Regulation (EU) 2025/2457 amends several existing regulations in order to reattribute scientific and technical tasks to ECHA and to improve cooperation among Union agencies in the area of chemicals.

While I believe this will take the Commission in a more holistic and coherent direction in their management of chemical risks across applications and regulations, I don’t believe it will resolve some of the fundamental issues I raised last month with EU RoHS. This does not help make the implementation of Article 5 any more sensible – the Commission’s term for what I was trying to say regarding the return on investment of the continued bifurcation and narrowing of exemptions is “proportionality.” That term is not found in the RoHS Directive. It also does not provide tools for the Commission (or Member States) to enable them to identify candidate substances that would be exclusive to EEE, such that their restriction by RoHS makes more sense than their being addressed by either POPs or REACH (or some other mechanism).

Yes, You Do Need Stinkin’ RoHS Test Requirements

On December 18, 2025, the EC quietly issued Commission Implementing Measure C(2025) 8725, directing the European Committee for Electrotechnical Standardisation (CENELEC) to extensively revise EN IEC 63000:2018, the “harmonised standard” for EU RoHS.

The direction given to CENELEC demands what amounts to a complete rewrite of the standard. No longer will the standard reflect industry best practices (which seem to have – as noted in my previous column – been quite successful in greatly reducing the amounts of the ten restricted substances in EEE), but will prescriptively demand analytical test results in the case of an “indication that there is a risk of jeopardising or impairing the objectives of Directive 2011/65/EU.” It will require the standard to define technical requirements for determining supplier risk. This will absolve manufacturers of having to use their experience, knowledge and expertise in determining risk.

The EC now believes that they are more competent at identifying supplier risk than the manufacturers themselves (yes, manufacturers are represented on the TC111X technical committee of CENELEC that will be responsible for producing this revision, but they are accountable to the EC). This amounts to a 180º about-face by the Commission from their stance when RoHS 2 first came into being in 2011.

While there certainly continues to be products entering the EU market that are NOT RoHS compliant (the vast majority of which appear to be manufactured by no-name companies in the Peoples’ Republic of China), this relatively small number of goods can, I believe, be addressed more efficiently and effectively by working directly with industry associations in the local manufacturing community or the manufacturers themselves to educate them about the requirements. As opposed to making everybody pay for the failure of the few.

One final point: testing is valid for only the lot of material subjected to the test. It has no bearing on or meaning for the next lot. Process control in the electronics supply chain is key to ensuring consistently compliant material. When trust is at a premium, test is an excellent tool for identifying potential issues – if the results are properly understood and acted upon as needed (that often doesn’t happen to this day, in my experience). But it’s no panacea and replacement for knowing your suppliers.

Quick Takes

Minnesota: The Minnesota Pollution Control Agency’s PFAS Product Reporting and Information System for Manufacturers (PRISM) is now up and available. Manufacturers (and their agents and representatives) can submit PFAS in product reports and pay related fees (the one-time reporting fee is $800). Links to both PRISM and a supplemental guide are available on the Reporting PFAS in products page. Reports are due for product currently shipping into Minnesota by July 1. Note that all information not identified as a trade secret will be available to the public so be sure to review your data for proprietary or confidentiality status prior to submission.

European Union: On November 11, 2025, the European Commission requested ECHA to prepare an Annex XV restriction dossier and issue a call for evidence on certain non-polymeric aromatic brominated flame retardants (ABFRs). The scope includes three ABFRs that are already classified as REACH SVHCs, at least one of which is relevant to EEE:

• CASRN 84852-53-9: 1,1'- (ethane-1,2-diyl)bis[pentabromobenzene], aka decabromodiphenyl ethane or DBDPE
  A number of additional ABFRs will be further evaluated in this process and are also subject to the call for evidence, including:
• CASRN 79-94-7: 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol, aka tetrabromobisphenol A or TBBPA

The call for evidence is looking for

1.     Stakeholders’ reactions to the restriction options being considered by ECHA

2.     Compliance costs of the restriction options and other economic impacts

3.     Information on alternatives

4.     Other impacts (e.g. social impacts, on trade, etc.)

Information on other topics, including hazard and risk information, can also be submitted in response to this call for evidence.

While there are technical and cost-related challenges to moving away from ABFRs, I repeat my admonition to review other methods and solutions to achieve flammability-related product safety – fire enclosures made of noncombustible materials, lower power, GreenScreen^® Benchmark 3 or 4 flame retardants etc. Make sure your safety engineers study and understand IEC 62368-1, Clause 6, “Electrically-caused fire.” Maybe they can identify ways to reduce cost and toxicity as well.

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