Europe Regulatory News

On 25 August 2023, the European Chemicals Agency (ECHA) announced that an amendment, Commission Delegated Regulation (EU) 2023/1656, has been made adding 35 additional hazardous chemicals to the EU’...

On 25 August 2023, the European Chemicals Agency (ECHA) announced that an amendment, Commission Delegated Regulation (EU) 2023/1656, has been made adding 35 additional hazardous chemicals to the EU’s Prior Informed Consent (PIC) Regulation. The amendment enters into force on 15 September 2023 and will apply from 1 November 2023.

Added chemicals

The 35 chemicals that were added to Annex I of the PIC Regulation include 27 pesticides and 8 industrial chemicals. The full list of chemicals can be seen below. These chemicals will require export notification and in addition most of them will also require an explicit consent from the importing country before exports can take place. The IT tool ePIC has been updated accordingly and companies can already start notifying their exports. 

* Sub-category: p(1) — pesticide in the group of plant protection products, p(2) — other pesticide including biocides. i(1) — industrial chemical for professional use and i(2) — industrial chemical for public use.

** Use limitation: sr — severe restriction, b — ban (for the sub-category or sub-categories concerned)

In addition to the 35 new entries to Annex I, four chemicals (triflumuron, cyfluthrin, chlorfenvinphos, and terbufos) that were previously subject only to an export notification, will now also require an explicit consent (i.e. they have been added to Part 2 of Annex I). 

Furthermore, it was decided at the tenth meeting of the Conference of the Parties (COP) to the Rotterdam Convention to include decabromodiphenyl ether and perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds in Annex III of that Convention. That means that those chemicals are now subject to the PIC procedure under the Rotterdam Convention. Consequently, those chemicals will be deleted from Part 2 of Annex I to Regulation (EU) No 649/2012 (the PIC Regulation) and instead added to Part 3 of Annex I. The entries in Part 3 are subject to the export notification requirement, and additionally to the explicit consent, except where an import response is published in the PIC circular of the Rotterdam Convention, and certain criteria are met.

Prior Informed Consent Regulation

The PIC Regulation (Regulation (EU) No 649/2012) implements the Rotterdam Convention within the EU. It promotes shared responsibility and cooperation in the international trade of hazardous chemicals. It also protects human health and the environment by providing importing countries with information on how to store, transport, use and dispose of hazardous chemicals safely.

It governs the trade of certain hazardous chemicals that are banned or severely restricted in the EU. It places obligations on companies that wish to export these chemicals to non-EU countries or import them into the EU.

The European Commission updates PIC Annex I, which lists the chemicals subject to export notification and explicit consent from the importing country. It now includes 295 entries.

On 24 August 2023, the transition period for the amendment of Annex XVII REACH regarding restriction of diisocyanates ends. The amendment, Commission Regulation (EU) 2020/1149, came into force on 23 A...

On 24 August 2023, the transition period for the amendment of Annex XVII REACH regarding restriction of diisocyanates ends. The amendment, Commission Regulation (EU) 2020/1149, came into force on 23 August 2020 and included a transition period of 3 years to allow the concerned workforce to undergo the required training.

After the end of the transition period the Restriction establishes requirements for the use and placing on the market of diisocyanates as substances on their own, as a constituent in other substances, or in mixtures for industrial and professional use(s) in concentrations above 0,1% by weight unless the user has successfully completed a training on the safe use of the substance. The training must include instructions for the control of dermal and inhalation exposure to diisocyanates at the workplace and must be conducted by an expert on occupational safety and health. The training must be renewed at least every 5 years. Details of the required training can be found in Regulation 2020/1149 here.

Placing on the market of diisocyanates has already been restricted since 24 February 2022. The requirements are that diisocyanates cannot be placed on the market as substances on their own, as a constituent in other substances or in mixtures for industrial and professional use(s) unless the concentration of diisocyanates individually and in combination is less than 0.1 % by weight and labelled with the information ‘As from 24 August 2023 adequate training is required before industrial or professional use’.

Diisocyanates are classified as respiratory sensitiser category 1 and skin sensitisers category 1. They are mainly used to make polyurethane products, such as foams, sealants, coatings and in the automotive industry.

Restricting the use of diisocyanates is estimated to prevent over 3 000 new cases of occupational asthma a year in the EU.

On 11 August 2023 the European Commission published an amendment, Regulation (EU) 2023/1627, to Annex I of Regulation (EU) No 10/2011 (the Food Contact Plastics Regulation) in the Official Journal of ...

On 11 August 2023 the European Commission published an amendment, Regulation (EU) 2023/1627, to Annex I of Regulation (EU) No 10/2011 (the Food Contact Plastics Regulation) in the Official Journal of the European Union.

The amendment grants authorisation for the use of bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (DEHCH) in the production of plastic food contact materials (FCMs) and will come into force on 31 August 2023.

In the amendment DEHCH is added Annex I of Regulation No 10/2011 which establishes a Union list of authorised substances that may be intentionally used in the manufacture of plastic materials and articles intended to come into contact with food.

The authorisation follows a safety assessment adopted by the Panel on Food Contact Materials, Enzymes, and Processing Aids (CEP) under the European Food Safety Authority (EFSA) in December 2019 on the use of DEHCH as a plasticiser in poly(vinyl chloride) (PVC) at up to 25 % w/w in contact with refrigerated or frozen aqueous, acidic and low-alcohol foods.

Based on a scientific study the CEP concluded that DEHCH does not raise genotoxicity concerns and that no adverse effects were observed in the toxicity studies. The CEP, however, expressed an uncertainty regarding the potential for accumulation of the substance in humans. It was therefore concluded that the migration of the substance should not exceed 0.05 mg/kg food and that it should only be used in PVC in contact with foods, for which simulants A (10 % ethanol) and B (3 % acetic acid) are assigned, at room temperature or below.

On 17 August 2023, the new EU Regulation (Regulation (EU) 2023/1542) concerning batteries and waste batteries entered into force and the Batteries Directive (Directive 2006/66/EC) was repealed. In the...

On 17 August 2023, the new EU Regulation (Regulation (EU) 2023/1542) concerning batteries and waste batteries entered into force and the Batteries Directive (Directive 2006/66/EC) was repealed. In the coming years the European Chemicals Agency (ECHA) will support the European Commission with tasks aiming to make batteries safer.

The development and production of batteries are strategic priorities for Europe in the transition towards clean energy. The global demand for batteries is increasing rapidly and is predicted to have a 14-fold increase by the year 2030. To minimise the environmental impacts of this growth and considering changes in society, new technological developments, markets and the uses of batteries, the European Commission has implemented the new Batteries Regulation. Some of the keypoints of the new regulation are as follows:

• Continue to restrict the use of mercury and cadmium in batteries.

• Introduce a restriction for lead in portable batteries.

• Aim to strengthen the internal market by ensuring a level playing field through a common set of rules.

• Promote a circular economy.

• Seek to reduce the environmental and social impacts throughout the entire life cycle of batteries.

ECHA will support the European Commission in the process by:

• Assisting in preparing a report on substances of concern contained in batteries or used in their manufacturing that have negative impacts on human health, the environment or recycling for safe and high-quality raw materials. It is expected that ECHA will begin its work toward this report in 2024 and present it by 31 December 2027.

• Preparing, if requested by the Commission, a restriction proposal on harmful substances used in the manufacturing of batteries or present in batteries when they are placed on the market, and in waste batteries in accordance with Annex XV of REACH.

• Providing an opinion through the committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) on the effectiveness of the restriction proposal in managing the risk and its impact on society.

Some more details on the new Battery Regulation can be found here.

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. REACH is a regulation of the European Union (EU), adopted to improve the protection of human health and the envir...

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. REACH is a regulation of the European Union (EU), adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness chemicals industry of the EU. It came into force on 1 June 2007. REACH also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.

 In a recent development, the Annex III Inventory of the REACH regulation, which comprises a compilation of substances deemed unlikely to benefit from reduced information requirements, has been officially withdrawn. Under the REACH regulation, companies are permitted to register substances with reduced information requirements, as long as these substances do not meet the criteria outlined in Annex III. Notably, the need to cross-reference the Annex III Inventory during the evaluation process to determine if a substance aligns with the criteria has been eliminated. This adjustment aims to streamline the registration process and enhance efficiency for companies navigating compliance within the framework of the REACH regulation.

 GPC can assist you to meet all your substance-related obligations under EU-REACH, such as full substance assessments, issuance of compliance certificates, and registration of chemicals. For more information, please email us at compliance@gpcregulatory.com or book a free consultation meeting here: https://meetings.hubspot.com/compliance7

On 3 July 2023, the EU’s Scientific Committee on Consumer Safety (SCCS) adopted Opinion on Water-soluble Zinc Salts Used in Oral Hygiene Products (II). Water-soluble zinc compounds are used in oral ...

On 3 July 2023, the EU’s Scientific Committee on Consumer Safety (SCCS) adopted Opinion on Water-soluble Zinc Salts Used in Oral Hygiene Products (II). Water-soluble zinc compounds are used in oral cosmetics to minimize mouth malodor, tartar, and plaque development. Water-soluble zinc salts are now controlled under Annex III to Regulation (EC) 1223/2009 (Cosmetics Regulation). Comments are accepted until 8 September 2023.

The SCCS assessment is based on overall exposure, which takes zinc in the diet into account. For toothpaste, it suggests a safe dosage of 0.72% for infants and toddlers. For all ages, 0.1% Zn zinc in mouthwash is considered safe.

Since the use of mouthwash is not suggested for children aged 5 and under, no mouthwash exposure evaluation is undertaken for this age group.

Estimated amounts of zinc exposure for both the separate products and aggregated exposures for children (0.5-5 years and 6-17 years) and adults.

On 8 August 2023, the EU published Regulation (EU) 2023/1068 in the Official Journal of European Union amending Regulation (EU) 2019/1021 known as the Persistent Organic Polutants (POPs) Regulation. I...

On 8 August 2023, the EU published Regulation (EU) 2023/1068 in the Official Journal of European Union amending Regulation (EU) 2019/1021 known as the Persistent Organic Polutants (POPs) Regulation. In the amendment perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds are officially listed in Annex I to Regulation (EU) 2019/1021. The amendment comes into force on 28 August 2023.

PFHxS is part of the group of compounds collectively known as per- and polyfluoroalkyl substances (PFASs). It is a used as a surfactant in a variety of industrial and commercial products such as food packaging, stain and water-resistant materials, fire-fighting foams, and paint additives. PFHxS, its salts, and PFHxS-related compounds are listed in Annex A to the Stockholm Convention since June 2022 without specific exemption. Each Party to the Convention is required to prohibit the chemicals listed in Annex A and/or take the legal and administrative measures necessary to eliminate their production, use, import and export. Therefore, Part A of Annex I to Regulation (EU) 2019/1021 which contains a list of the substances listed in the Convention has been amended to include PFHxS, its salts and PFHxS-related compounds. In accordance with Regulation (EU) 2019/1021 the manufacturing, placing on the market and use of substances whether on their own, in mixtures or in articles) listed in Annex I, is prohibited (if no exemptions apply).

The amendment sets the following a limit value for PFHxS, its salts and PFHxS-related compounds occurring as an unintentional trace contaminant in substances, mixtures and articles.

• ≦ 0.025 mg/kg for PFHxS or any of its salts

• ≦ 1mg/kg for the individual PFHxS-related compounds or sum of concentrations of all PFHxS-related compounds

• For the use in firefighting foams where those limit values cannot currently be met, higher concentration limits should be established, subject to review by the Commission no later than 28 August 2026 with a view to lowering the limits.