| Document Properties | |
|---|---|
| Feedback to: | Holly Krijgsman |
| Published: | 21-11-2024 |
| Public Document | |
Materials and Processes Technology Board ( MPTB )
REACH Background
Registration, Evaluation, Authorisation and Restriction of Chemicals*
Overview
The Regulation (EC) No 1907/2006 concerning the registration, evaluation, authorisation, and restriction of chemicals (REACH) is the main EU law to protect human health and the environment from the risks that can be posed by chemicals. This is done by better and earlier identification of the intrinsic properties of chemical substances and by taking measures, such as phasing out or restricting substances of very high concern (SVHC) and other substances posing an unacceptable risk.
The REACH processes are administered by the European Chemicals Agency (ECHA) in Helsinki (Finland). Key initiatives and decisions on authorisation and restrictions are taken by the European Commission and the Member States, sometimes also involving the European Parliament.
Additional European regulations, such as those addressing workplace materials and chemicals, Occupational Exposure Limits (OELs), and other related legislations, complement the REACH. All of them can lead to sudden discontinuation and obsolescence of space-relevant materials and processes. Therefore, a good knowledge of materials and their chemical content is an essential prerequisite when selecting materials for projects with extended on-ground life.
Scope of application
The REACH Regulation applies in the European Union (currently 27 EU Member States), Iceland, Liechtenstein and Norway (EEA) and Northern Ireland. The United Kingdom has its own chemicals regulation (UK REACH, since 2021), which is very similar to EU REACH but has fallen somewhat behind EU REACH in terms of its implementation status. Switzerland has its own rules as well (such as ChemO and ORRChem) but follows the EU REACH implementation closely.
There is no general exclusion from REACH requirements, however sector-agnostic exemptions may apply on a case-by-case basis (e.g. use as fuels in closed systems, scientific R&D). Note that the space sector benefits from scope exclusions for “equipment designed to be sent into space” under some other EU laws (e.g. for batteries, electrical and electronic equipment/EEE – Restrictions of Hazardous Substances (ROHS), mercury) but not under REACH.
REACH processes
The REACH processes to identify, regulate and – in some cases – ban chemical substances due to their hazardous properties for human health or the environment are complex and relatively long. Figure 1 provides a simplified illustration of how such substances move through the EU regulatory process based on EU REACH and ECHA’s substance management activities.
Figure 1 Simplified REACH substance management process (reference ECSS-Q-HB-70-23)
Substances targeted under REACH
Some key examples of substances concerned by REACH and of interest for the space sector are chromates (e.g. surface treatments), hydrazine (e.g. propellant), bisphenols (e.g. epoxy resin formulations), toluene (e.g. in paints), metallic lead (e.g. solders) and potentially the entire “universe” of PFAS (per- and polyfluoroalkyl substances) in the not-so-distant future.
It should be noted that these examples are far from being exhaustive. ESA has developed a dedicated ESA REACH Tool to track the impact of substance regulation under REACH on space-relevant materials and processes.
Obsolescence
REACH is the strictest law to date regulating chemical substances. It is a very desirable and ambitious regulation to contribute to a safer and healthier environment. At the same time, many chemical substances face regulatory or commercial obsolescence, causing widespread impacts to downstream users including in the European space sector, as well as wide-reaching engineering and management challenges to ensure compliance and substitution where necessary and possible. These negative impacts of REACH regulation on space-critical supply chains are often unintended, nevertheless European space industry must address them via complex and costly substitution activities.
Compliance obligations
Space companies and their subcontractors may face different obligations under REACH, in particular:
- Reporting on Candidate List SVHCs in articles in the supply chain (REACH Article 33(1)) and to ECHA (SCIP Database notification). Example: Lead metal above 0.1 % w/w in electronic part, printed circuit boards (PCBs) and other components.
- REACH Article 66 notification to ECHA to continue the use of a SVHC included in REACH Annex XIV (the Authorisation List) under an “upstream authorisation”. Example: Use of chromium trioxide in chemical conversion coating on aluminium alloy parts.
- Restrictions (REACH Annex XVII) for substances presenting an unacceptable risk to human health or the environment. Example: Training requirements for diisocyanates (Entry 74); compliance with worker exposure limit for 1-methyl-2-pyrrolidone/NMP (Entry 71).
Regulatory monitoring and response
New substances are added continuously to the SVHC Candidate List (current updates around January and June each year) and new restrictions are being prepared. Industry must anticipate these changes to maintain compliance and provide available input to ECHA and European Commission consultations and calls for evidence on own uses, possible impacts and the availability of alternatives.
The MPTB and its sub-groups on REACH aspects have a key role to play in performing regulatory monitoring and joint contribution development to the regulators.
Examples: European Space Sector comments on the REACH restriction proposal for certain bisphenols of 22 May 2023 (available HERE) and for PFAS of 22 September 2023 (available HERE).
Regulatory awareness
ESA, with external consultancies and partners in the space sector, works to raise awareness of regulations like REACH. They offer webinars, workshops, and presentations (ESA SME office: https://learninghub.esa.int/ ). Previous event presentations and workshop summaries are available on the "List of MPTB Contributions with References" page (link).
Contact for further questions: reach.officer@esa.int
