Background on EU chemicals regulatory guidance
- So-called REACH implementation projects (RIPs) served to develop the first series of guidance resources intended to help stakeholders meet their obligations under the REACH and CLP Regulations (1907/2006/EC and 1272/2008/EC), EU’s principal cross-sectoral chemicals legislation. After the initial versions of these documents were drafted through RIPs – undertakings that were spearheaded by the European Commission, with input and participation from non-governmental organizations (NGOs), industry representatives and member-state authorities – the responsibility of maintaining and further developing guidance was assigned to ECHA, as anchored in the provisions of REACH (Article 77) and CLP (Article 50) concerning the core duties of the agency.
- Today, the steps for creating chemical regulatory guidance are laid down in ECHA documents, including the Provision of new guidance and guidance update (PRO-0012) and the Consultation procedure for guidance (PRO-0011.11). They establish the formal rules for drafting new and updating existing guidance, providing a key role for stakeholders to play in formulating these documents.
- “The procedure includes the organisation and management of the consultation with ECHA partners intended to ensure a broad acceptance of the guidance,” as stated in the purpose section of the Consultation procedure for guidance. That is, obtaining buy-in from all stakeholders affected by the guidance is central to ECHA’s objectives. See the flowchart on page 7 of the Consultation procedure document for a succinct overview of guidance development and consultation steps, including interaction between partner expert groups (PEG); ECHA committees (e.g., risk assessment committee – RAC); the Enforcement Forum; the Commission; and member-state authorities.
Scope and type of guidance
- ECHA offers a whole host of resources on its website, providing clarification on many aspects of the chemicals legislation under the agency’s remit. As can be seen by visiting this main page on guidance under the “ Support” tab, ECHA provides guidance in several different formats, including (1) detailed guidance documents addressing the legislation under ECHA’s purview (so far, limited to REACH, CLP, Biocidal Products Regulation (BPR – 528/2012/EU) and the Prior Informed Consent Regulation (PIC – 649/2012/EU)); (2) fact sheets, which detail specific regulatory elements, primarily for REACH and CLP, not otherwise covered by the guidance documents (e.g., the public classification and labeling (C&L) inventory, cost elements in data sharing under REACH, compliance with the CLP when manufacturing candles); and (3) “ Guidance in a nutshell,” which, as the title implies, presents a concise rundown of various chemicals legislation features.
- The agency has several other useful resources beyond reference materials explaining EU chemicals legislation. These include (1) practical guides, which clarify specific aspects of compliance based on real-life examples and best practice (e.g., “how to use and report (Q)SARs?”); (2) ongoing guidance consultations providing insight into which guidance documents are currently under review and where they are in the updating process; formats and templates that facilitate certain tasks under REACH and other chemicals legislation, like providing a uniform template for compiling the chemical safety report (CSR); and (3) manuals on preparing REACH and CLP dossiers in the International Uniform Chemical Information Database (IUCLID) environment.
- ECHA hosts a valuable questions and answers (Q&A) database, which allows users to input questions in free form using keywords. The database also includes extensive filtering capabilities, enabling searches based on predetermined topics (e.g., REACH, CLP, BPR, PIC), scopes (e.g., cosmetics, safety data sheets, evaluation, registration) and chapters. It includes a helpful four-minute-long video tutorial on using the database’s functionalities.
Chemicals regulation guidance needs
- Which guidance you’re interested in learning more about will obviously depend on your current level of understanding of the EU’s chemicals framework and what your particular chemical regulatory compliance needs are.
- For absolute beginners or those who want to understand whether they have any obligations at all under REACH, the CLP, or other relevant parts of the EU chemicals framework, the “ Getting started” page under ECHA’s Support tab is probably the best place to begin. This page provides a batch of various questions which, when answered, can help point the user in the right direction.
- For more sophisticated users, already conversant in EU chemical regulation and with an idea about what they’re looking for, the Support tab provides an excellent overview of and one-stop-shop access to all possible types of guidance and other regulatory resources, including (1) links to the guidance documents at the bottom of the page; (2) various tools addressing different chemical regulatory elements, such as the chemical safety assessment and reporting tool (Chesar) under REACH and SCIP, the database for information on Substances of Concern in articles as such or in complex objects (Products), established under the Waste Framework Directive (WFD); and (3) the Q&A page.
- Finally, the Support tab provides users links to contact the authorities to obtain regulatory (REACH, CLP, BPR, PIC, etc.), technical (IUCLID, REACH-IT, chemical data on ECHA website, etc.), and other types of support (e.g., invoicing, access to documents, speaking requests).
To contact the author of this piece, email Scott Stephens ( sstephens@agencyiq.com).
To contact the editor of this item, please email Jason Wermers ( jwermers@agencyiq.com).
Key Documents and Dates
- Guidance on REACH
- Guidance on CLP
- Practical Guides
- Guidance in a nutshell
- Ongoing guidance consultations
- ECHA’s questions and answers (Q&A) database
- ECHA’s Support page offering one-stop-shop access to guidance and other online resources
- Consultation procedure for guidance (PRO-0011.11), ECHA, September 15, 2021