Written on: March 1, 2024 by Cassandra Taylor
The European Chemicals Agency (ECHA) Enforcement Forum coordinates various projects in Europe to harmonize enforcement in each Member State and check the current level of compliance regarding obligations under European Union (EU) hazardous products regulations. A significant proportion of non-compliance was found during recent enforcement projects BPR-EN-FORCE-2 (BEF-2) and REACH-EN-FORCE-10 (REF-10).
Under the BEF-2 project, national enforcement authorities in 29 countries checked over 3,500 biocidal products for compliance in the EU, European Economic Area (EEA) and Swiss markets. The BEF-2 project focused on non-allowed active substances in biocidal products, approval of the active substance suppliers, and obligations related to labeling, packaging and advertising of biocidal products. Overall, approximately 60 substances that are not permitted in biocides were found and 37% of the evaluated products exhibited non-compliance with the Biocidal Products Regulation (BPR).
Eighteen percent of checked products were non-compliant with fundamental requirements that affect their safe use. For the most part, these either lacked a product authorization or included non-permitted active substances. The product types that were the biggest offenders included disinfectants, insecticides and repellents/attractants. All products that lacked authorization or contained prohibited active substances were withdrawn from the market and, in some cases, criminal complaints or fines were issued.
The remaining 19% of non-compliant products had minor deficiencies that do not affect safe use, such as missing supplier information. National enforcement authorities gave advice or administrative orders to correct these minor issues.
Under the REF-10 project, national enforcement authorities in 26 EU countries checked over 2,400 products intended primarily for consumers. Of the products checked, more than 400 were found to be non-compliant according to EU chemical regulations. The worst offenders were electrical devices, 52% of which were found to contain restricted chemicals such as lead in solders, phthalates in soft plastic parts or cadmium in circuit boards. Other product types—including sports equipment, toys and fashion products—had instances of non-compliance in the 15–18% range due to the presence of chemicals of concern such as phthalates, short-chain chlorinated paraffins (SCCPs) and polycyclic aromatic hydrocarbons (PAHs).
Instances of non-compliance were more prominent in products originating from outside the EEA or with unknown origin. Inspectors have taken enforcement measures in the cases where non-compliant products were found, resulting in the withdrawal of many such products from the market.
Research priorities for hazardous chemical regulation
ECHA published a new report, Key Areas of Regulatory Challenge 2023, identifying areas where research is needed to protect people and the environment from hazardous chemicals and highlighting where new methods are needed to support the shift away from animal testing. ECHA asserts that scientific research must deliver data that is relevant to regulating chemicals to further improve chemical safety. As a result, the following areas have been identified as priorities:
• Hazard identification for critical biological effects that currently lack specific and sensitive test methods (developmental and adult neurotoxicity; immunotoxicity and endocrine disruption)
• Chemical pollution in the natural environment (bioaccumulation; impact on biodiversity; exposure assessment)
• Shift away from animal testing (read across under Registration, Evaluation, Authorization & Restriction of Chemicals [REACH]; move away from fish testing; mechanistic support to toxicology studies, e.g. carcinogenicity)
• New information on chemicals (polymers; nanomaterials; analytical methods in support of enforcement)
The report also highlights why these topics are of regulatory importance and how the new scientific knowledge is expected to be used in the EU’s chemicals management.
The priorities were developed under the European Partnership for the Assessment of Risks from Chemicals (PARC). PARC is a seven-year, EU-wide research and innovation program under Horizon Europe that aims to advance research, share knowledge and improve skills in chemical risk assessment. The list of research needs is not exhaustive; they are meant to inform and inspire the scientific community and are expected to evolve over time. The next update to the report is anticipated this Spring.
EU Commission 2024 Work Programme
The 2024 European Commission Work Programme, which was adopted on Oct. 17, 2023, details initiatives for the year with an emphasis on simplifying rules for citizens and businesses across the EU. Previously, the Commission set a target to reduce reporting requirements by 25%, without undermining the objectives of the concerned initiatives. The motivation to reduce the administrative burden of compliance is reflected in the proposals, which are in alignment with the strategy to boost the EU’s long-term competitiveness and provide relief to small and medium-sized enterprises (SMEs) that are disproportionately affected by the various chemical compliance obligations.
Ahead of the 2024 European elections, the Commission outlined 26 new proposals in the Programme. The plan aims to deliver on the outstanding commitments, of which fewer than 10% remain, that are yet to be delivered under the 2019 Political Guidelines and to address emerging challenges.
The main approaches to streamline reporting requirements will include the removal of duplication and the use of digitalization. The Commission also plans to expand e-platforms for data management to ensure standardization and to develop artificial intelligence tools and language models.
Annex I to the Work Programme identifies the new initiatives and Annex II, entitled Significant proposals and initiatives to rationalize reporting requirements and evaluations and fitness checks, covers various regulatory reform proposals. Of those nominated to undergo reforms, the regulation on detergents and surfactants might be one for SPRAY readers to keep an eye on. The proposed changes would simplify and digitize reporting requirements for detergent products by introducing a digital product passport and ingredient data sheet for hazardous substances.
Annex III to the Work Programme for “Pending Proposals” includes a proposal for the revision to the regulation (1272/2008) on the Classification, Labeling & Packaging (CLP) of substances and mixtures, as well as amendments to the packaging and packaging waste laws. The CLP update is discussed further in the final section.
Absent from the Work Programme and its annexes is any mention of the anticipated revision to the EU REACH regulation (1906/2007). It is unclear why this update is not included since it is part of the EU Chemicals Strategy for Sustainability.
Annex IV features intended withdrawals of pending proposals. The European Commission has released two fact sheets entitled Commission Work Programme 2024 explained and Reducing burden & rationalizing reporting requirements that provide a concise summary of the Commission’s strategy for 2024.
EU authorities reach provisional agreement for revised EU CLP regulation
In line with the Work Programme and the Chemicals Strategy for Sustainability, the EU Council and Parliament have reached an agreement on the text for the revision to the EU CLP regulation. This update is in addition to the new hazard classifications that were discussed in the June 2023 issue of SPRAY.
The legislation that amends the existing 2008 EU regulation attempts to improve communication of chemical hazards, address legal deficiencies and clarify rules in relation to online sales and labeling of hazards products. Digital labeling is a new topic that will be covered under CLP, which will provide rules for the use of voluntary digital labeling and related technical requirements to ensure accessibility for users.
Once the update comes into effect, there will be new standards for the font size of warnings and minimum size requirements for label pictograms appearing on packages. More flexibility is welcomed as the new rules permit broader use of fold-out labels.
Advertisements for hazardous mixtures will no longer be allowed to include difficult to prove “Green claims” such as “non-toxic,” “non-harmful,” “non-polluting,” “ecological” or any other statements that are inconsistent with the classification. The updated legislation will also create the opportunity for the Commission, Member States and industry to expedite the process for identifying hazardous substances and making new classification proposals.
The timeline for implementation is not yet known because both the EU Parliament and Council need to formally approve the agreement before it can enter into force.
As always, feel free to reach out to us at Nexreg Compliance Inc. with your EU compliance questions. SPRAY
