Europe Regulatory News

On the 7th of March 2022, the EU notifies the decision to not approve N-(3-aminopropyl)-N-dodecylpropane1,3-diamine as an existing active substance for use in biocidal products. This decision was m...

On the 7^th of March 2022, the EU notifies the decision to not approve N-(3-aminopropyl)-N-dodecylpropane1,3-diamine as an existing active substance for use in biocidal products. This decision was made due to the human health risks posed by the substance. The EU focuses on harmonizing the EU market for biocidal products while protecting human health and the environment.

During the assessment of the substance in 2020, ECHA identified an unacceptable risk both for primary and secondary exposure, relating to industrial users and the scenario of infants and toddlers playing on the playground, respectively. However, there is no unacceptable risk for the environment if the appropriate measures are taken. Combining the two assessments, the conclusion is that there is no safe use or mitigation measures that can be adopted for avoiding the substance’s health risks.

The final date to comment on this proposal is the 6^th of May 2022. 

On the 23rd of February 2022, the REACH Annex XV restriction dossier was published addressing PFASs’ risks in firefighting foams to human health and the environment. The European Chemicals Agency ...

On the 23^rd of February 2022, the REACH Annex XV restriction dossier was published addressing PFASs’ risks in firefighting foams to human health and the environment. The European Chemicals Agency (ECHA) proposes an EU-wide restriction on all per- and polyfluoroalkyl substances (PFASs) in firefighting foams.

The proposal by ECHA is aimed at preventing further contamination of the soil and its health risks to people and the environment. It is known that PFASs have caused environmental contamination to the soil and drinking water in the EU.

If adopted, there will be a transition period for industries to replace PFASs in the firefighting foams. Industries will also have to properly dispose expired and waste foams while transitioning away from using these PFASs. The consultation period for this proposal starts from the 23^rd of March 2022 for six months, during which anyone can give comments.

Based on the proposal, the transition period will include:

• three years for civilian ships
• five years for portable fire extinguishers
• five years for any other use
• 8 months for training and testing
• 10 years for fire service establishments covered by the Seveso Directive, and
• 18 months for municipal fire services (except if they are also in charge of establishing industrial fires, which is covered by the Seveso Directive)

European Commission publishes 12 delegated acts to end the exemptions for the use of mercury in lamps. These lamps include general-purpose compact (CFL) and linear fluorescent (LFL) lamps. Conside...

European Commission publishes 12 delegated acts to end the exemptions for the use of mercury in lamps. These lamps include general-purpose compact (CFL) and linear fluorescent (LFL) lamps. Considering the wide availability of mercury-free alternatives, this announcement will enter into force on March 16, 20 days from when it was published. The EU Member States have six months to modify their national legislation to include these delegated acts.

Before now and according to the EU rules (RoHS Directive) that restricts the use of hazardous substances in electronic equipment, electronics with mercury can only be placed on the market when certain exemptions are given by the Commission.

However, according to this new announcement, the Commission cancels all exemptions regarding the use of mercury. Mercury-free alternatives are widely available for industries and manufacturers to use. This is in response to the proposal submitted to the European Parliament and Council in December 2021.

The European Commission, after a serious struggle, recently declared resorcinol as an SVHC. This decision was made based on the endocrine-disrupting properties of human health. This decision was mad...

The European Commission, after a serious struggle, recently declared resorcinol as an SVHC. This decision was made based on the endocrine-disrupting properties of human health.

This decision was made by a voting process where 19 member states voted in favour and three members voted against, while five member states were absent. Those who voted in favor represent 54% of the EU’s population which is short of the 65% threshold necessary for passing a majority vote. However, the vote was passed considering only three member states voted against the decision, this is below the minimum four that makes up a ‘blocking minority’ under Article 16 of the Treaty on European Union (TEU). 

Following this decision, resorcinol will now be added to the REACH candidate list ending a long battle of adding or not adding the substance to the SVHC list. This struggle has been ongoing since 2020 when the committee couldn’t decide. An agreement wasn’t made because there were disagreements over if the substance causes an equivalent level of concern under REACH as a carcinogenic, mutagenic or reprotoxic (CMR) chemical, or one that is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB).

Resorcinol is a high-volume compound used for producing rubber products, tyres, industrial resins, adhesives, and some cosmetic and medical products. And scientific evidence shows the serious effects the substance has on human health.

You can view the commission implementing decision here and the formal voting results here.

Last Update: 2022-02-14

Under EU Cosmetics Regulation, the commission banned some uses of methyl-n-methylanthranilate as a fragrance ingredient. This is an ingredient usually used in the production of shampoos, soaps, and ...

Under EU Cosmetics Regulation, the commission banned some uses of methyl-n-methylanthranilate as a fragrance ingredient. This is an ingredient usually used in the production of shampoos, soaps, and other beauty products.

In alignment with the initial proposal presented by the Commission last year, the substance is banned from sunscreen products and other products marketed for natural or artificial UV light exposure. The substance is phototoxic; therefore, it shouldn’t be used with nitrating agents. The new restriction also says that the maximum nitrosamine content should be 50 micrograms per kilogram and cosmetic products containing methyl-n-methylanthranilate should be kept in nitrite-free containers.  

However, it is ascertained that there are no safety concerns for this substance in a concentration of up to 0.2% in rinse-off products and up to 0.1% in many leave-on cosmetic products.

Conclusively, from 21^st August 2022, cosmetic products that do not comply with the restrictions should not be placed in the EU market and should not be available from 21^st November 2022.

Last Update: 2022-02-08

ECHA regularly recommends substances from the Candidate List to be included in the Authorisation List (Annex XIV to REACH), based on the information in the registration dossiers on uses and volumes ...

ECHA regularly recommends substances from the Candidate List to be included in the Authorisation List (Annex XIV to REACH), based on the information in the registration dossiers on uses and volumes of the substance. On February 2, 2022, ECHA lists eight new substances to be included in the authorisation list. Comments for this proposal are invited until May 2, 2022.  

If a substance is included in the Authorisation List, it can only be placed on the market if an authorization is granted for a specific use and that is after a given date. Below is the eight substances listed by ECHA and companies that are using, manufacturing or importing these substances may have to apply for authorisation if these are added to Annex XIV of REACH regulation. As of now companies can send their proposal for defending the substances for not including it to Authorization list and ECHA will review those comments before taking the final decision on inclusion of these substances into Authorization list.

On the 18th of January 2022, ECHA advises on how to determine and apply dose selection for dose and reproductive toxicity. This is in alignment with OECD guidelines. The director of ECHA for Hazard As...

On the 18th of January 2022, ECHA advises on how to determine and apply dose selection for dose and reproductive toxicity. This is in alignment with OECD guidelines. The director of ECHA for Hazard Assessment said the amended REACH annexes and the guidance instructions given by ECHA will help companies when doing toxicity tests to ensure that the correct dose level is used.

This advice is aimed at ensuring that test results reliably show whether a chemical has severe health effects or not. Furthermore, it prevents the repetition of inconclusive tests and animal suffering. REACH also has alternatives to animal testing for companies. This guidance document prepared by ECHA will be revised to consider the amended REACH annexes, therefore, the publication will be done later in the year.

Why is this guidance document important? Companies need to select the correct substance dose when doing toxicity tests of their chemicals’ safety as stipulated in the amended REACH annexes. This amendment applies from January 2022, therefore, companies will need as much guidance as possible to comply with this new rule.

According to ECHA, companies should:

(1) ensure that the data they generate from toxicity tests are suitable for hazards’ identification and risks’ assessment of chemicals.

(2) prevent the severe suffering of animals when conducting animal testing.

(3) Toxicity tests should be done at a high dose level that appropriately complies with the OECD test guideline.

The current guidance document can be accessed here.

Last Update: 2022-01-21