The guidance helps companies and authorities assess the risks to bees from biocidal active substances and products. It is part of wider EU initiatives that aim to reverse pollinator decline by 2030 and preserve biodiversity.
Helsinki, 14 February 2024– ECHA’s guidance document presents an approach to assess the risks of biocides to honey bees, bumble bees and solitary bees, based on the latest scientific knowledge. It addresses uses of products such as insecticides and acaricides (product-type 18). Substances in these products may, for example, harm the bees’ nervous system and weaken their immune system, so that they are more susceptible to diseases.
The guidance will assist companies applying for active substance approvals or product authorisations under the EU’s Biocidal Products Regulation to conduct the risk assessment for their applications. It also explains the guiding principles for authorities to evaluate applications and to conclude on a biocidal product’s compliance with the authorisation conditions.
ECHA will host a webinar on the guidance on 5 March from 11:00 to 13:00 Helsinki time.During the event, experts involved in preparing the document will give an overview of its content and respond to questions from participants.
The European Commission and EU Member States will decide at a later stage when the guidance needs to be applied in the assessment of biocides.(more…)
The European Chemicals Agency (ECHA) has today published its Strategy Statement 2024-2028. The strategy details the agency’s goals and priorities over the next five years to protect health and the environment through its work for chemical safety.
Helsinki, 30 January 2024– With its new strategy, ECHA will deliver on its existing wide legal mandate, build on its expertise and experience, collaborate with our stakeholders and partners, implement new tasks and support the ambition of the EU policy goals on chemicals. In support of these actions, we will also invest in our people so they too are ready for ECHA’s future work.
Main elements of the strategy – goals and priorities:
-Be a trusted chemicals agency;
-Respond to emerging challenges and changes in our legal landscape;
ECHA CHEM is a new solution for publishing information on chemicals. The first release, available now, includes information from all REACH registrations – and there is more to come.
Helsinki, 30 January 2024– ECHA maintains the largest chemicals database in the European Union (EU), combining industry-submitted data with information generated in the EU’s regulatory processes. ECHA CHEM is the new solution to share with the public the growing amount of information hosted by the Agency.
In the first version of ECHA CHEM, you can find information from all the over 100 000 REACH registrations that companies have submitted to ECHA. Later this year, the database will be expanded with the redesigned Classification and Labelling Inventory, followed by the first set of regulatory lists.
ECHA’s current Information on chemicals platform, launched in 2016, grew rapidly and contains today information on over 360 000 chemicals. In 2022, ECHA announced that it would create a new system for publishing chemicals data. ECHA CHEM allows the Agency to better handle the growing diversity and quantity of data, while taking advantage of technological advancements.
Scientific Committee on Consumer Safety SCCS OPINION on Methylparaben (CAS No. 99-76-3, EC No. 202-785-7 adopted by written procedure on 14 December 2023.
„On the basis of the safety assessment considering all available data and the concerns related to endocrine activity, the SCCS is of the opinion that the use of Methylparaben as a preservative in cosmetic products at concentrations of up to 0.4% (expressed as acid) is safe.“
ECHA has added five new chemicals to the Candidate List.
One of them is toxic for reproduction, three are very persistent and very bioaccumulative and one is toxic for reproduction and persistent, bioaccumulative and toxic. They are found in products such as inks and toners, adhesives and sealants and washing and cleaning products.
The Agency has also updated the existing Candidate List entry for dibutyl phthalate to include its endocrine disrupting properties for the environment.
Entries added to the Candidate List on 23 January 2024:
REASON FOR INCLUSION
EXAMPLES OF USE(S)
Toxic for reproduction (Article 57c)
Persistent, bioaccumulative and toxic (PBT) (Article 57d)
Manufacture of another substance; formulation of mixtures and in fuel products.
Metal working fluids, washing and cleaning products, laboratory chemicals and polymers.
Consequences of the Candidate List
Under REACH, companies have legal obligations when their substance is included – either on its own, in mixtures or in articles – in the Candidate List.
If an article contains a Candidate List substance above a concentration of 0.1 % (weight by weight), suppliers have to give their customers and consumers information on how to use it safely. Consumers have the right to ask suppliers if the products they buy contain substances of very high concern.
Importers and producers of articles have to notify ECHA if their article contains a Candidate List substance within six months from the date it has been included in the list (23 January 2024).
EU and EEA suppliers of substances on the Candidate List, supplied either on their own or in mixtures, have to update the safety data sheet they provide to their customers.
Under the Waste Framework Directive, companies also have to notify ECHA if the articles they produce contain substances of very high concern in a concentration above 0.1 % (weight by weight). This notification is published in ECHA’s database of substances of concern in products (SCIP).
An EU-wide enforcement project of the ECHA Forum found excessive levels of hazardous chemicals, such as lead and phthalates, in products that are sold to consumers. In total 18 % of the inspected products breached the EU laws.
Helsinki, 13 December 2023 – The national enforcement authorities in 26 EU countries checked over 2 400 products, most of them intended for consumers, and found more than 400 of them breaching the EU’s chemicals laws.
The most common product types breaching the laws were:
Electrical devices such as electrical toys, chargers, cables, headphones. 52 % of these products were found non-compliant, mostly due to lead found in solders, phthalates in soft plastic parts, or cadmium in circuit boards.
Sports equipment like yoga mats, bicycle gloves, balls or rubber handles of sport equipment. 18 % of these products were found to be non-compliant mostly due to SCCPs and phthalates in soft plastic and PAH in rubber.
Toys like bathing/aquatic toys, dolls, costumes, play mats, plastic figures, fidget toys, outdoor toys, slime and childcare articles. 16 % of non-electric toys were found to be non-compliant, mostly due to phthalates found in soft plastic parts, but also other restricted substances such as PAHs, nickel, boron or nitrosamines.
Fashion products such as bags, jewellery, belts, shoes and clothes. 15 % of these products were found non-compliant due to the phthalates, lead and cadmium they contained.
In cases where non-compliant products were found, inspectors have taken enforcement measures, with most of them resulting in the withdrawal of such products from the market.
The non-compliance rate was higher in products which originated from outside the European Economic Area (EEA) or whose origin was not known.
This enforcement project checked if different types of products that are sold to consumers and professional users on the EEA market comply with the EU chemical regulations.
The project covered REACH restrictions, duties applicable to substances in articles under REACH, POPs restrictions and restrictions derived from the Toys and the RoHS Directives. The checks were carried out by the national enforcement authorities in 26 countries during 2022.
In the upcoming years (2024-2025), the Forum and BPRS will focus on harmonizing the enforcement of key EU regulations, including REACH, CLP, POPs, PIC, and BPR. While these are the primary areas of concentration, the Forum retains flexibility to address emerging issues or new priorities.
Horizontal Enforcement Priorities
1.Imports and Customs Cooperation:
Prioritizing control of imports and collaboration with customs, driven by alarming non-compliance rates—ranging from 17% to 64%—for various regulations, as highlighted in recent enforcement projects.
Addressing the significant non-compliance (over 75%) in online sales of chemicals, leveraging new legislations to strengthen enforcement measures.
Streamlining enforcement of substances, mixtures, or articles regulated by multiple legislations to enhance efficiency and resource utilization.
Focusing on cross-border cooperation and collaboration with various inspection services to effectively enforce legislation, including initiatives like integrated enforcement.
Specific Enforcement Priorities:
Regulatory Risk Management Measures:
Emphasizing the enforcement of measures targeting substances of concern, with a focus on improving compliance levels for REACH Restrictions, Authorisation, CLP Harmonised Classification and Labelling, POPs Restrictions, and BPR product authorisation.
2. Information in the Supply Chain:
Prioritizing harmonized enforcement of duties related to information flow in the supply chain, addressing deficiencies in safety data sheets (SDS) and improving compliance.
3. Classification and Labelling:
Addressing the high non-compliance levels in the classification and labelling of mixtures, with a focus on CLP Regulation duties.
4. New Provisions:
Proactively harmonizing enforcement of new provisions that have fully entered into force, such as hazardous mixture notification and new requirements for online sales.
Priorities for ways of working in 2024-2025
The work of the Forum goes beyond coordinating enforcement of specific provisions. Inprioritising its work, the Forum will be guided not only by the need to enhance compliancewith specific duties (‘enforcement priorities’), but also by a clear preference on how itsobjectives should be achieved. This includes the preference for practical enforcementthrough projects and swiftly addressing political and regulatory developments, such as theneed to work closely with customs or advise on enforceability of important new restrictions.Therefore, the Forum will also consider the following overarching priorities during theperiod of this Work Programme.
The Forum has dedicated over 15 years to executing synchronized enforcement projects, aligning control practices, consolidating compliance data, and furnishing guidance for inspectors. These projects, the linchpin of EU enforcement, are instrumental in fortifying and harmonizing regulatory compliance. The Forum and BPRS will persist in prioritizing these projects, adapting to evolving mandates for optimal efficiency. Emphasizing enforceability advice for new restrictions, the Forum draws on its extensive experience evaluating the viability of proposals under REACH. As legislative shifts expand restrictions, the Forum anticipates heightened demand for enforceability advice, necessitating procedural enhancements and resource reinforcement. Augmented collaboration with stakeholders remains integral for sustained compliance improvements, with ongoing efforts to engage through open sessions, workshops, and regular communications via ECHA channels. Acknowledging potential changes in its mandate due to REACH revision, the Forum commits to flexible adaptation, scrutinizing new tasks and opportunities to effectively deliver on evolving priorities and practices.
In summary, the enforcement priorities for 2024-2025 aim to enhance compliance, streamline enforcement efforts, and adapt to potential changes in regulations and mandates.
The 1 January 2024 compliance date for poison centre notifications is not an immediate cut-off. Rather, it mandates that, starting from this date, all new notifications for mixtures intended solely for industrial use (in addition to consumer and professional use) must adhere to the harmonised format detailed in Annex VIII of the CLP Regulation. This also includes a UFI code on the label.
ECHA reminds companies to assess their notification status and check the timelines for having the information in the required harmonised format.
This message is particularly important to those companies that have existing notifications submitted according to national requirements. In such cases, it is possible to benefit from the transition period, ending 1 January 2025. However, if changes occur in the product or mixture during this period, then information needs to be submitted in the new format which is possible through the ECHA submission portal.
Companies that benefit from the transition period can already begin planning how and when to update their notifications and manage their re-labelling plans.
For more details, watch ECHA webinar on this topic or reach out to the national of yours or ECHA Helpdesk.
The purpose of the assessment of regulatory needs of a group of substances is to help authorities conclude on the most appropriate way to address the identified concerns for a group of substances or a single substance, i.e. the combination of the regulatory risk management instruments to be used and any intermediate steps, such as data generation, needed to initiate and introduce these regulatory measures.
An assessment of regulatory needs can conclude that regulatory risk management at EU level is required for a (group of) substance(s) (e.g. harmonised classification and labelling, Candidate List inclusion, restriction, other EU legislation) or that currently no (further) regulatory action is required at EU level. While the assessment is done for a group of substances, the (no) need for regulatory action can be identified for the whole group, a subgroup or for single substance(s).
The assessment of regulatory needs is an important step under ECHA’s Integrated Regulatory Strategy. However, it is voluntary, i.e., it is not part of the processes defined in the legislation but aims to support them. Assessing regulatory needs is an iterative process that can start from a low level of information and certainty on the best way forward to proposing more definitive regulatory management options for the (groups of) substance(s).
Assessment of regulatory needs – an interative process
The assessment of regulatory needs can be applied to any group of substances or single substance, and can cover any type of hazards or uses, regardless of the previous regulatory history or lack of such. It can be done based on any level of information. A Member State or ECHA can carry out this case-by-case analysis. The starting point is available information on hazards and information on uses in the REACH registrations and any other REACH and CLP information. However, a more extensive set of information can be available, e.g. quantitative exposure and risk information from registration, assessments done under REACH/CLP or other EU legislation. Where needed further information can also be generated to progress with the group (e.g. under dossier evaluation). Uncertainties associated to the level of information used should be reflected in the documentation.
The assessment will be revisited when necessary. For example, after further information is generated and the hazard has been clarified or when new insights on uses and risks are available. It can be revisited by the same or another authority.
Before initiating a formal regulatory risk management process under REACH/CLP, authorities can optionally make a further, in-depth analysis of the most appropriate regulatory risk management option (RMOA).
The responsibility for the content of this assessment rests with the authority that developed it. It is possible that other authorities do not have the same view and may develop a further assessment of regulatory needs for the same (group of) substances.
Even if an assessment of regulatory needs concludes that regulatory action should be initiated, such an outcome does not have any direct legal implications.
To gain legal and regulatory relevance, the substances assessed need to successfully pass one or more of the formal regulatory management and decision-making processes under REACH, CLP such as harmonised classification and labelling (CLH), SVHC identification or authorisation, or restriction or other legislations. The intentions of authorities to submit a dossier to REACH/CLP formal processes are notified through the Registry of Intentions.
The outcome of the assessment of regulatory needs is shared in order to increase transparency and predictability of authorities’ work.