On September 20, 2018, the European Chemical Agency (ECHA) launched a consultation for input on the upcoming SVHCs in articles database. Development and use of the database are mandated by the revised European Waste Framework Directive (WFD) that was published in June 2018 – see the July and August ECD Environmental Reports for additional background. The consultation period was very short, ending on October 9, 2018.
The supporting documentation and examples provided by ECHA during the consultation suggests that manufacturers, importers, distributers and/or retailers will be tasked to submit more detailed information on REACH SVHCs in products than previously expected by industry and may go beyond the mandatory requirements written in the regulations. This could impose a significant burden for companies, especially those with a large product portfolio.
ECHA was tasked to create a database for manufacturers, importers, distributers and retailers to submit information on products that contain SVHCs above the REACH threshold – reporting will be required by the end of 2020.
ECHA provided two documents describing their current vision for the database and the information that companies will be expected to submit into the database. The expectation is that all articles manufactured in the EU or imported into the EU and containing at least one SVHC above the REACH reporting threshold, will need to be reported in the database.
Overview of Information to be submitted
The first document “Draft scenario for a database on Candidate List substances in articles” provides background to the new database, indicating that every article or complex object that contains a Candidate List SVHC will need to be listed in the database with:
- Administrative/company data (related with submission management)
- Article/complex object data:
- Identification of the article/complex object
- Description of the article/complex object
- Candidate List substance data
- Safe use information
Proposed Technical Details
The second document “Technical supporting document” provides some technical details on the proposed reporting requirements. The technical document provided by ECHA states that:
For complex objects, each supplier in the supply chain (in the production part of the supply chain) would need to provide the following types of additional information:
- Identification of the complex object incorporating articles containing Candidate List substances: refers to the name of the complex object, the unique identifier (ID) and other identifiers which allow the identification of the specific complex object placed on the market;
- Description of the complex object: refers to characteristics and/or use(s), as well as an explicit reference to each article containing Candidate List substances in the complex object;
- Safe use information: refers to information for allowing the safe use of the complex object and to manage the risks from the incorporated articles containing Candidate List substances.
ECHA expects that a unique identifier will be assigned to the product and that information submitted by the manufacturer, etc. will indicate the specific type of product. ECHA is currently considering the:
- United Nations Standard Products and Services Code (UNSPSC) classification scheme
- Global Product Classification (GPC) standards, or the
- Combined nomenclature (CN codes) (which are already being used to import products into the EU)
The document also suggests that information needs to be submitted about the type of material containing the SVHC, concentration levels, whether the article is used by consumers or by workers, etc. and for complex objects, information identifying the specific articles containing the SVHC(s) (see Figure 1).
Safe Use Information
ECHA is considering how best to communicate safe use information. The information needs to cover all life cycle stages, including at end of life. Their preference is to use a set of standardized statements for consistency providing advice to workers, consumers, waste treatment operators. The technical annex document provides examples of such statements, although ECHA was clearly looking for feedback from stakeholders before finalizing a strategy:
Advice to workers:
- Wear respiratory protection in processing operations generating dust (e.g. grinding, drilling)
- Avoid prolonged direct contact with skin during use
Advice to consumers:
- Avoid prolonged direct contact with skin during use
- Keep out of reach of children
- Keep away from heat, hot surfaces, sparks, open flames
- Do not mix with municipal waste
- For outdoor use only
Advice to waste treatment operators:
- Dispose of as hazardous waste
- Waste incineration is recommended
Data submission format
ECHA indicated that they plan to use a harmonized EU-wide format for submission into the database and that the SVHC in article database will be based on IUCLID (the database used by the chemical industry to register substances under the REACH regulation). They’ve suggested that their existing electronic submission tool (REACH-IT) will be used. REACH-IT is fine for complex substance registrations; however, it will be unnecessarily challenging and time consuming for SVHC reporting.
Several standards committees have submitted responses to the ECHA consultation suggesting that an industry standard material declaration data format be used. Submissions were made for: IEC 62474 (EEE), IPC-1754 (Aerospace and Defense), and IPC-1752A (EEE).