Europe Regulatory News

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.

On June 8, 2022, the European Commission published a proposal on Polyvinyl chloride (PVC) articles that contain lead and lead compounds. The draft proposal amends Annex XVII, specifically entry 63, pr...

On June 8, 2022, the European Commission published a proposal on Polyvinyl chloride (PVC) articles that contain lead and lead compounds. The draft proposal amends Annex XVII, specifically entry 63, prohibiting the use of lead and lead compounds in PVC articles.

Overall, PVC articles that contain a concentration of lead equal to or greater than 0.1% of the PVC cannot be placed on the market. However, there are quite some exceptions, some of which apply to PVC-silica separators in lead acid batteries and PVC articles that contain recovered rigid PVC. To qualify for the exemption, the recovered origin of the PVC material must be certified by an independent third party.

This new amendment is aimed at reducing lead releases and human exposure to this toxic metal while protecting human health overall. The proposed date of adoption is the fourth quarter of 2022 while its entry into force will be 20 days from when it is published in the official journal of the EU. Then the restriction on lead stabilisers’ use and placement of PVC articles containing lead on the market will be postponed for two years after its entry into force. Comment on this will close on August 7, 2022.

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.

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, 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.