Europe Regulatory News

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.

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 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. 
 

The European Commission updates the glossary of ingredient names commonly used in cosmetics production. This was done to correct the names of ingredients that were written incorrectly while some were ...

The European Commission updates the glossary of ingredient names commonly used in cosmetics production. This was done to correct the names of ingredients that were written incorrectly while some were updated to comply with the recent changes made in the Personal Care Product Council’s (PCPC’s) International Nomenclature of Cosmetic Ingredients (Inci) list. 

To this effect, companies have to ensure that the chemicals listed on their cosmetic products’ labels comply with the new list. The deadline to do this is April 29, 2023. This is a part of the EU’s vision and strategy for sustainability, which has started by changing certain regulations like this.

 You can access the glossary of the common ingredients’ names here.

The European Chemicals Agency (ECHA), together with the Member States reviewed a group of 148 bisphenols, of which 38 bisphenols have potential reprotoxic or hormonal effects. Bisphenols are common...

The European Chemicals Agency (ECHA), together with the Member States reviewed a group of 148 bisphenols, of which 38 bisphenols have potential reprotoxic or hormonal effects.

Bisphenols are commonly known as endocrine disrupters for human health and the environment. Endocrine disrupters are slow to break down in the environment and it causes adverse effects on human health. According to ECHA, bisphenols are mostly used in manufacturing polymers or polymer resins, thermal paper, adhesives, textiles, and paper.

Since bisphenols are widely used, the recommendation is to enact a group restriction as the best way to manage the risks posed by the 30 bisphenols. Before now, three bisphenols have been identified as Substances of Very High Concern (SVHC). These chemicals are bisphenol A, bisphenol B, and 2,2-bis(4'-hydroxyphenyl)-4-methylpentane. For other group members in bisphenol, there is a need to generate more data before confirming the endocrine-disrupting and reprotoxic properties.

Exports and products involved with perfluorooctanoic acid (PFOA), its salt forms, and PFOA-related compounds are banned after the European Commission makes addition to Annex V of the Prior Informed Co...

Exports and products involved with perfluorooctanoic acid (PFOA), its salt forms, and PFOA-related compounds are banned after the European Commission makes addition to Annex V of the Prior Informed Consent (PIC) Regulation. Echoing the Stockholm Convention on Persistent Organic Pollutants (POPs), the entry of the chemicals is monitored and this further urges parties concerned to prohibit exports that contain such substances.

In Annex I of the PIC Regulation, export notification requirements for 22 chemicals are at the same time addressed. The regulated range includes 15 pesticides, 7 industrial chemicals, and all substances that contain benzene as a constituent at concentrations above 0.1% weight by weight. Imports of restricted chemicals under the effect of the PIC Regulation were seen to have decreased by 20% over the same period, though the number of substances exported was reported higher than in the previous year according to the European Chemicals Agency (ECHA).

The PIC Regulation amendments were published on April 20, 2022, and will enter into force on July 1, 2022, after which the EU exporters will have to specify their intention of exporting the chemicals listed and receive explicit consent from the import destination before exports take place.