Europe Regulatory News

On the 15th of June 2022, the European Commission notified its draft decision to not approve methylene dithiocyanate as an existing active substance to be used in biocidal products of product-type 12....

On the 15^th of June 2022, the European Commission notified its draft decision to not approve methylene dithiocyanate as an existing active substance to be used in biocidal products of product-type 12. This is in accordance with Regulation (EU) No 528/2012 of the European Parliament and the Council.

This new decision means that biocidal products of product-type 12 containing methylene dithiocyanate are not expected to meet the criteria laid down in Article 5(1) for specific points. It is quite challenging to confirm the minimum purity of the active substance and to set a reference specification for the substance considering applicants’ inability to submit data of an excellent quality to meet data requirements in points 2.7, 2.8, and 4.1.

Point 2.7: Specification of purity of the active substance in g/kg or g/l, as appropriate

Point 2.8: Identity of impurities and additives together with the structural formula and the possible range expressed as g/kg or g/l, as appropriate.

Point 4.1: Analytical methods for the determination of the pure active substance and where appropriate, for relevant degradation products, isomers, and impurities of the active substance and additives.

All these points are of Title II of Annex IIA to Directive 98/8/EC. It is also impossible to confirm that the materials used to conduct ecotoxicological studies cover the presented specifications and to conclude on the impurities’ relevance since there is no ecotoxicological data.

Additionally, an environmental risk assessment identified unacceptable risks and there is no suitable risk mitigation measure to adopt. The proposed date of adoption is September 2022 and entry into force will be 20 days from its publication in the Official Journal of the EU.

The European Commission plans to put a stop to the REACH restriction procedure for cobalt salts while focusing on setting occupational exposure limits (OELs) for the compound. This decision follows a ...

The European Commission plans to put a stop to the REACH restriction procedure for cobalt salts while focusing on setting occupational exposure limits (OELs) for the compound. This decision follows a debate on how best to manage risks for the compounds.  

This concerns five cobalt salts that were already due to become substances under REACH authorization. However, the Commission decided that it will be better and more suitable to restrict them. Therefore, cobalt salts now have a binding OEL under Osh legislation and this will protect workers better than before.

Cobalt salts are used for manufacturing chemicals, batteries, catalysts, biogas, and feed-grade materials. The fourth revision to the carcinogens, mutagens and reprotoxic substances Directive (CMRD) includes the Commission’s obligation to propose a limit value for cobalt and inorganic cobalt compounds latest by December 31, 2024.

The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) consults on its opinion regarding the safety of titanium dioxide in toys until July 4, 2022. Co...

The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) consults on its opinion regarding the safety of titanium dioxide in toys until July 4, 2022.

Considering the classification of titanium dioxide in the EU as a category 2 carcinogen via inhalation, SCHEER had to evaluate available products to ascertain the level of safety in using the substance in toys and toy materials. The conclusion of their evaluation says toys containing titanium dioxide are considered safe if manufacturers prove that the products contain no ultrafine particles.

Titanium dioxide is a substance used in white pigments and inhalation exposure can occur with products that release particles. Therefore, when ultrafine particles are present in the products, SCHEER suggested that safe use should not be indicated for casting kits, chalks, and powder paint. However, the use of titanium dioxide as a colouring agent for polymers in toys poses no risk since the pigment for such is locked in. But if it is not embedded in polymer, substance release is highly possible.

For finger paints, white colour pencils, lipstick and lip gloss, SCHEER do not affirm them as safe for use for children. The hazard characterization for immunotoxic, genotoxic, and carcinogenic activity is highly uncertain.

ECHA’s Committee for Risk Assessment (RAC) has expressed its support for restricting the use of lead in ammunition for hunting, outdoor sports shooting, and fishing by adopting its opinion on ECHA�...

ECHA’s Committee for Risk Assessment (RAC) has expressed its support for restricting the use of lead in ammunition for hunting, outdoor sports shooting, and fishing by adopting its opinion on ECHA’s proposal to restrict the use of lead for relevant activities. The use of lead in these situations is reckoned as posing non-adequately controlled threats to people, wildlife, and the environment, especially for birds.

Once adopted, this restriction would reduce lead emissions by 72% compared to previously non-restricted situations, preventing the poisoning of wildlife, including many endangered species, and reducing exposure to vulnerable population groups.

The restriction proposal was developed at the request of the European Commission, in line with the EU’s Green Deal, its Chemicals Strategy for Sustainability, and the Zero Pollution Action Plan for water, air, and soil. However, military uses of lead ammunition and other non-civilian uses of lead ammunition such as by police, security and customs forces, are still beyond the scope of the restriction proposal as well as indoor uses of lead ammunition.

Despite RAC’s consent to the ECHA proposal, it nevertheless recommended a shorter transition time to phase out lead gunshots in hunting. The highlights of the Committee are listed below:

• The proposed restriction is effective, practical, and monitorable as a measure to address the risks without many modifications.
• A five-year transition period to phase out lead in gunshot for hunting as initially proposed is not necessary, seeing as the use of lead gunshot in wetlands is already regulated in the EU; the shorter the transition period means the less lead that would possibly be released into the environment.
• Labelling of ammunition and fishing sinkers containing lead and information to consumers at the point of sale is recommended, and the need to label products and inform consumers of products’ risks should be triggered at a concentration threshold of 1% (weight by weight), which is the same threshold as restricting the use and placing on the market of lead ammunition and fishing sinkers, which is different from what ECHA originally proposed (a threshold of 0.3% w/w);
• Abolishment of derogation for a lead gunshot in sports shooting is considered for the convenience of easier enforcement of the restriction, which is in line with ECHA’s preferred restriction option; in the case where the decision-maker deems this derogation needed, it is RAC’s suggestion to limit shot sizes used in sports shooting (between 1.9 and 2.6 mm).

RAC did the assessment by evaluating the reliability and representativeness of data provided by the European Food Safety Authority (EFSA) and the available scientific studies on the relevant risks. This assessment was done during opinion-making, where the former data presented somehow robustly demonstrated risks to vulnerable populations like children and pregnant women, especially to the children’s neurological development.

ECHA has also updated its initial proposal, where the key updates are explained in the Q&A document, and this updated proposal as a background document shall be available soon. The Committee for Socio-economic Analysis (SEAC) is expected to agree to the draft opinion in early June, where a 60-day consultation on SEAC’s draft opinion will soon start afterwards and it will be finalized in December.

The opinions of both committees are expected to be ready by the end of 2022, which will then be sent to the European Commission at the start of 2023, and at last, the decisions on REACH restrictions are taken by the European Commission along with the EU countries, scrutinized by the Council and the European Parliament.

You can also read about the EU's proposal to restrict lead and lead compounds in PVCs here.

With the purpose to facilitate the “One substance, one assessment" process, the European Commission plans to review and improve the current way of how chemicals’ required data are gathered and dis...

With the purpose to facilitate the “One substance, one assessment" process, the European Commission plans to review and improve the current way of how chemicals’ required data are gathered and disseminated under different EU laws. This proposal is expected to impact multiple regulations due in the first half of 2023.

This legislative proposal adheres to the Chemical Strategy for Sustainability (CSS), where this action aims at committing the Commission to enhance the information flow of chemical data among EU and national authorities. The current information barriers to data exchange such as intellectual property rights, data exclusivity rules, and regulatory data protection, etc., would be the focus, according to the Commission. Also at the same time, it is one of the main concerns from the industry on how to properly deal with intellectual property and the ‘free-rider’.

Disadvantaged examples of information reuse can be seen from, for instance, ECHA has no legality to reuse copyrighted data on biocidal product authorization for a REACH application authorization, nor to send it to the European Food Safety Authority (EFSA) for approving a pesticide active substance – the data generated is practically far from reusable under different regulatory processes and assessments. 

This upcoming proposal regarding data usage will address topics that include the following:

• Introduction of a data generation mechanism that could help the authorities fill information gaps – it is similar to the verification tool under the EU Transparency Regulation in some way, allowing the commissioning of additional studies in exceptional circumstances and no new data requirements is said to be introduced.  
• Requirements on business operators and laboratories to notify EFSA if they are commissioned to undertake a study – this helps the authorities keep track of new coming data, which shall be stored in an EFSA database.  
• Development of a common data platform.   
• EU repository of health-based limit values – this promotes their reuse and harmonization among risk assessors and managers; and  
• Tools to improve the uptake of academic data – this could include guidance for minimum quality of studies that will help researchers in designing and reporting them, and a search guide to help regulators and industry find and retrieve relevant academic data.  

The proposal is most likely to be formed as an “omnibus regulation” to amend provisions on data flow, dissemination and reuse in individual pieces of chemicals and product legislation. The EU executive will soon launch a call for evidence for the legislative proposal.

As aforementioned, IP concerns remain one big issue for this system-level amendment as it is one of the goals for the EU Commission to open the IP access. Pertinent problems such as data ownership and Intellectual Property (IP) rights are questioned by the industry representatives during the information session. The proposal is directed to where the industry could still be able to claim confidentiality of Confidential Business Information (CBI). As for the data ownership, the tricky part lies in determining the carrier of the cost of data used for multiple assessments yet managing the risks of free-riding to protect property.

To boost the access and reuse procedures of information sharing, the CSS prompts the Commission to establish a common data platform for chemicals. Such platform forms part of the horizontal data proposal, giving the authorities easy access to all legally accessible information, some of which will be made public. The information presented on the platform shows:

• identifiers  
• intrinsic properties  
• presence in articles and use  
• data on emissions   
• data on exposure  
• hazard and risk assessments, and  
• limit values.  

The detailed implementation plan is currently being drafted by ECHA along with other agencies and the Commission, ideally going live in 2025. A technical blueprint, operational steps, and the estimation of the resources needed for building and maintenance of the tool, are expected to be included in the implementation guidelines.

On the 10th of June 2022, ECHA added an entry on n-(hydroxymethyl)acrylamide (NMA) to the REACH candidate list. This addition was done due to the carcinogenic and genotoxic properties of the chemical,...

On the 10^th of June 2022, ECHA added an entry on n-(hydroxymethyl)acrylamide (NMA) to the REACH candidate list. This addition was done due to the carcinogenic and genotoxic properties of the chemical, posing possible threats to cause cancer or genetic defects.

Adding this to Annex XIV authorization list means companies will have to apply and obtain permission to continue using NMA. This chemical is mostly used in polymers and also used in manufacturing other chemicals, textiles, leather and fur products. NMA was also proposed in Sweden for an SVHC identification due to its classification for carcinogenicity 1B and germ cell mutagenicity 1B.

Henceforth, importers and producers of articles have to notify ECHA if their article contains NMA. The notification should be done within six months, counting from June 10, 2022. Suppliers of substances on the candidate list also have to provide their clients with a safety data sheet (SDS). As a supplier of articles containing a candidate list substance that is above a concentration of 0.1% (weight by weight), you must provide your clients and consumers with adequate information about the safe use of such articles. You must also notify ECHA about substances of very high concern (SVHC), to the Substances of Concern in Products (SCIP) database that is under the waste framework directive.

With this new addition, the candidate list now consists of 224 substances. Other substances on the list are potential names to be placed on the Authorization List. This implies that the use of these substances might be prohibited someday unless an application for authorization is submitted by any of the concerned companies. The process does not end there until the European Commission authorizes the continued use of the concerned regulated substance.

The European Commission on June 1, 2022, announced its proposal to approve didecyldimethylammonium chloride (DDAC) as an active substance for use in biocidal products of product-types 1 and 2. It was ...

The European Commission on June 1, 2022, announced its proposal to approve didecyldimethylammonium chloride (DDAC) as an active substance for use in biocidal products of product-types 1 and 2. It was proposed under the Biocidal Products Regulation (BPR) and in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council.

DDAC is approved for use in products made for human hygiene and disinfectants and algaecides that are not to be directly applied to humans or animals, product-type one and two respectively.

The proposed date of adoption is August and entry into force will be 20 days after the implementing regulation has been published in the official journal. The proposal is open for public comments until July 30, 2022. As affirmed by the Commission, this is aimed at ensuring that the EU market is harmonized on biocidal products and that human health, and the environment are highly protected.