Europe Regulatory News

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 

The Candidate List of Substances of Very High Concern (SVHC) now contains 223 entries. On 17th January 2022, ECHA added four hazardous chemicals that are commonly used in cosmetics to the candidate li...

The Candidate List of Substances of Very High Concern (SVHC) now contains 223 entries. On 17th January 2022, ECHA added four hazardous chemicals that are commonly used in cosmetics to the candidate list.

Under the REACH regulation, companies have obligations if their substances are included in the candidate list, either as a substance in mixture, or in articles.

Manufacturers and importers of articles have to notify ECHA, if their article contains a Candidate List substance, within six months from the date it was included in the list (17 January 2022). Suppliers of substances on the Candidate List have to provide their customers with a safety data sheet (SDS).

If the products contain SVHC in a concentration above 0.1 % (weight by weight), companies have to also notify to the SCIP database.

Last Update: 2022-01-21

In December 2021, the European Commission adopted the proposal of a new EU Directive aimed at reducing environmental crime. This proposal defines new environmental crimes, obliges Member States to tak...

In December 2021, the European Commission adopted the proposal of a new EU Directive aimed at reducing environmental crime. This proposal defines new environmental crimes, obliges Member States to take criminal law measures and sets the minimum level for punishment.

The proposal has a newly set EU environmental criminal offenses (illegal ship recycling, illegal timber trade, illegal abstraction of water) and will make investigations and criminal proceedings more relevant and effective.

In the proposal, penalties have been set for companies that conduct illegal activities.  Some of them include the following:

• Where the offense cause or is likely to cause death or serious injury to any person, the penalty must be at least for imprisonment of up to ten years.
• Restoration of environment/nature within a selected period.
• Denial of access to public funds and business procurement procedures.
• Withdrawal of administrative permits and business practice disqualification

Fines are expected to be set by Member states to be no less than 5% of a company’s overall (worldwide) turnover. The commission will take the next step by submitting the proposal to the European Parliament and the Council.

Last Update: 2022-01-14

On the 11th of January 2022, the European Commission granted a temporary exemption for the use of lead in the following electronic materials: bismuth strontium calcium copper oxide superconducto...

On the 11th of January 2022, the European Commission granted a temporary exemption for the use of lead in the following electronic materials:

• bismuth strontium calcium copper oxide superconductor cables
• wires
• and lead in their electrical connections

The commission also renewed Annex IV on the use of lead in solders, termination coatings of electrical and electronic components and printed circuit boards, connections of electrical wires, shields and enclosed connectors for magnetic resonance imaging (MRI) devices.

Comments on these notifications are opened from 11th of January to 11th of March 2022. The notification drafts are expected to be adopted in March 2022 and will enter into force three months after adoption.

Last Update: 2022-01-12

On the 16th of December 2021, the commission confirmed that the exemption for mercury in linear fluorescent (LFL) lamps and single capped (compact) fluorescent lamps will be revoked. This is beca...

On the 16th of December 2021, the commission confirmed that the exemption for mercury in linear fluorescent (LFL) lamps and single capped (compact) fluorescent lamps will be revoked. This is because the uses of mercury can be sufficiently substituted in these lamps.

The commission also decided that this substitution will generate energy savings and stimulate innovation. The proposals have been submitted to the European Parliament and Council for a two-month scrutiny, during which the Parliament will either accept or reject the proposed drafts. If accepted, lamps containing mercury will have to phase out within 18 months from the implementation date. For the compact lamps, the earliest phasing-out period will be 12 months.

Last Update: 2022-01-12

A study and ingredients’ comparison done for 20 perfumes in Belgium, Denmark, and the Netherlands revealed that these perfumes contain substances of concern that have been listed by authoritative bo...

A study and ingredients’ comparison done for 20 perfumes in Belgium, Denmark, and the Netherlands revealed that these perfumes contain substances of concern that have been listed by authoritative bodies. The study shows the presence of 26 problematic substances in 20 perfumes, and they can be categorised into the following groups:

• Suspected Endocrine Disrupting Chemicals (EDCs)
• Reprotoxic Substances
• Allergens
• Substances that are harmful to the environment

The dangerous substances and their functions include:

This study was conducted by the Danish Consumer Council, Dutch NGO Erase All Toxins and Flemish NGO Stand up to Cancer. They suggest that an alternative is to use perfumes that have been awarded the EU or Nordic Swan Ecolabels. A full document on the study can be accessed here.

Last Update: 2022-01-04