Europe Regulatory News

According to ECHA, there is a new intention to identify a Substance of Very High Concern (SVHC) from Belgium together with France. The substance of interest is 4,4'-sulphonyldiphenol (i.e. Bisphen...

According to ECHA, there is a new intention to identify a Substance of Very High Concern (SVHC) from Belgium together with France. The substance of interest is 4,4'-sulphonyldiphenol (i.e. Bisphenol S (BPS), EC 201-250-5, CAS 80-09-1), and the following three aspects are of specific concern:

• Toxic for reproduction (Article 57c)
• Endocrine disrupting properties (Article 57(f) – environment)
• Endocrine disrupting properties (Article 57(f) – human health)

The expected date of SVHC dossier submission is set on August 4, 2022 in cooperation with France, after which the assessment process will be initiated. This is what concerned individuals need to pay close attention to.

As per Laboratory Chemical Safety Summary (LCSS) Datasheet, 4,4'-sulphonyldiphenol is categorized as bearing “irritant” and “health hazard”. It is commonly used in fast-drying epoxy glues, as a reactant in polymer reactions, or as a building block in polyethersulfone and some epoxies. Its comparable estrogen-mimicking effects to Bisphenol A (BPA) do not make it less health-threatening when it is firstly intended to replace BPA, and the use of BPS is now under greater and greater discussion.

According to ECHA, the once selected substance silver-polyethylenimine-chloride, as a new chemical to join in the biocides review programme now needs some new concerned business bodies to continue its...

According to ECHA, the once selected substance silver-polyethylenimine-chloride, as a new chemical to join in the biocides review programme now needs some new concerned business bodies to continue its approval process.

The original uses applied for this substance are:

• Human hygiene (product-type 1);
• Disinfectants and algaecides not intended for direct application to humans or animals (product-type 2); and
• Fibre, leather, rubber and polymerised materials preservatives 
  (product-type 9).

Biocide Products Regulation is now openly recruiting notifications till May 23, 2023 in order to keep this substance registered in the programme. Concerned individuals and those required to notify should follow up on the updates for a good understanding/convenience of future regulation and compliance issues.

Recently, the opinions of the Committee for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) were made available publicly on the ECHA website for undecafluorohexanoic acid (PFHxA). An initial ...

Recently, the opinions of the Committee for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) were made available publicly on the ECHA website for undecafluorohexanoic acid (PFHxA). An initial proposal was made by Germany to set restrictions for undecafluorohexanoic acid (PFHxA) along with its salts and related substances (EC -, CAS -) in 2019.

Some details on the desired scope of restriction include:

• PFHxA shall not be manufactured or placed on the market as substances on their own from the enforcement of such regulation.
• From the enforcement of such regulation, PFHxA shall not be used in the production of, or placed on the market in:
  (a) another substance, as a constituent;
  (b) a mixture;
  (c) an article, in a concentration equal to or above x %.

Concerned individuals should pay close attention to updates following this adoption of the final opinions by the RAC and the SEAC, after which there would be the adoption of the restriction by the European Commission.

Following the proposal of five new Persistent Organic Pollutants (POPs), interested parties are now invited to comment on the draft regarding the respective substances listed below. These substances w...

Following the proposal of five new Persistent Organic Pollutants (POPs), interested parties are now invited to comment on the draft regarding the respective substances listed below. These substances were proposed for listing as POPs under the Stockholm Convention. 

Parties are invited to review and comment on draft risk management evaluations for:

• Dechlorane Plus (EC -, CAS 2921-88-2); and
• 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)
  (EC 247-384-8, CAS 25973-55-1).

Parties are invited to review and comment on draft risk profiles for:

• Chlorpyrifos (EC 220-864-4, CAS 2921-88-2);
• Chlorinated paraffins with carbon chain lengths in the range C14–17 and chlorination levels ≥ 45 % chlorine by weight (EC -, CAS -); and
• Long chain PFCAs, their salts and related compounds
  (EC -, CAS -).

Relevant comments should be sent by July 19, 2022. Concerned individuals should be attentive to preparation and compliance requirements for future chemical uses that involve the aforementioned substances.

According to ECHA, France submitted a new Harmonised Classification and Labelling (CLH) registry proposal of fluoroethylene (EC 200-832-6, CAS 75-02-5) in May 2022. The dossier to this intention regis...

According to ECHA, France submitted a new Harmonised Classification and Labelling (CLH) registry proposal of fluoroethylene (EC 200-832-6, CAS 75-02-5) in May 2022. The dossier to this intention registry has been submitted and it is under accordance check.

Fluoroethylene, also called vinyl fluoride, is classified as an International Agency for Research on Cancer (IARC) Group 2A carcinogen, meaning that exposure to this substance is likely to cause cancer in humans. This colourless, chemically-stable gas is used as the starting material in making polyvinyl fluoride, a plastic used in films for weather-resistant coatings of structural materials.

Individuals who use this substance should look forward to further updates on it.

According to the EU Commission, the EU executive is sketching an alternative to add the endocrine-disrupting chemical Resorcinol to the REACH candidate list. It had been consensually approved earlier ...

According to the EU Commission, the EU executive is sketching an alternative to add the endocrine-disrupting chemical Resorcinol to the REACH candidate list. It had been consensually approved earlier in February with industry and member states, subsiding the once disputed scientific evidence behind the intention.

After the Commission corrected the voting outcome finalized by the REACH Committee in January to "no opinion" based on legal advice, the EU Commission has been forced to make a U-turn for the controversy over the decision of identifying resorcinol as a Substance of Very High Concern (SVHC). The misinterpreted vote by EU member states had delivered a split verdict instead of an endorsement of the draft regulation as initially understood.

In line with the legislation on comitology rules, the executive will either amend the draft decision seeking a potential compromise and reach a positive opinion between member states, or present the original draft decision to the appeal committee, aiming at reaching a positive opinion at a politically higher level. Despite the controversy, it is nonetheless not planned to reverse the draft implementation Decision.

In its original plan, it is ideal for the Commission to defer the SVHC decision until the new criteria of endocrine disruptors are developed under the Classification, Labelling, and Packaging (CLP) Regulation in the pipeline. However, strong opposition was argued from the Rescorcinol Task Force (RTF), for the status quo appeared unclear for concerned individuals regarding if the two above mentioned options would be available in practice.

The European Chemicals Agency (ECHA) and the European Food and Safety Authority (EFSA) announced on May 10, 2022, that an ongoing assessment of the health and environmental risks of glyphosate will be...

The European Chemicals Agency (ECHA) and the European Food and Safety Authority (EFSA) announced on May 10, 2022, that an ongoing assessment of the health and environmental risks of glyphosate will be delayed. Glyphosate-based herbicides are the most widely used weedkiller in agriculture.

Under EU Regulation 1107/2009, concerning the placing of plant protection products on the market, active substances must secure approval from the European institutions before they can be used in plant protection products. Said approval is limited in duration  to a maximum of 10 years, although it can be renewed if requested. Both the initial approval and subsequent renewals are decided upon after a process where the Member States and the European Food and Safety Authority review the existing evidence on the substance’s health and environmental impacts.

Currently, glyphosate is undergoing procedures for the renewal of its approval under the plant protection products regulation (for which EFSA is the relevant EU agency), and for its harmonized classification under Regulation 1272/2008, on classification, labelling and packaging of substances and mixtures (handled by ECHA). The current approval for glyphosate under the plant protection products regulation will expire on 15 December 2022. However, the public consultations run by both agencies have seen very high levels of participation which – together with additional information provided by the applicants for the renewal – have added a significant amount of information to the dossier. 

This additional information will be thoroughly considered by the Assessment Group on Glyphosate (AGG), composed of four EU Member States (France, Hungary, the Netherlands, and Sweden). Therefore, EFSA and ECHA are postponing their findings to have enough time to assess the contributions submitted. The revised timeline for the remaining steps in the re-evaluation process and publishing of the assessment is July 2023. 

In light of the above, it is expected that the European Commission will expand the current approval until a decision can be reached based on EFSA’s recommendations.