REACH
The regulation
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals. The implementation of the REACH processes is managed by the European Chemicals Agency (ECHA) in Helsinki (Finland), in close collaboration with the EU/EEA Member States and the European Commission. REACH enforcement is carried out by the EU/EEA Member States. The European Commission has key decision-making powers, e.g. in the authorisation process and for the adoption of new restrictions.
REACH contains four regulatory regimes: Registration (requiring manufacturers and importers of chemicals to analyse and submit information on substances); Evaluation (checking the quality of registration dossiers and whether a given substance constitutes a risk to human health or the environment); Authorisation (identifying certain Substances of Very High Concern (SVHC), possibly including them on the authorisation list with a defined “sunset date”, with a view to assuring their progressive substitution with safer alternatives, and authorising certain uses of these substances); and Restriction (restricting the manufacture, placing on the market and/or use of certain chemicals presenting an unacceptable risk). To decide on the most appropriate regulatory measure to address a concern (authorisation, restriction, occupational exposure limits, etc.), ECHA/Commission and the Member States conduct Regulatory Management Option Analyses (RMOA).
For a substance to be covered by the REACH authorisation system it must be first included in the Candidate List (211 substances on it in February 2021). The next step is its inclusion in the Authorisation List (Annex XIV – 54 substance as per February 2021 – plus a number of candidate list substances recommended for inclusion). From there on the substance will be “banned” from use or sale in the EU/EEA from a determined date (the sunset date). Its use after sunset date will be possible under the regime of a granted authorisation (or, exceptionally, the application of exemption clauses).
The REACH Article 33 obligation for EU/EEA article suppliers to communicate safe use information on SVHCs on the Candidate List in articles in the supply chain is another area posing significant challenges for the Space Sector, especially after the “Complex Article” judgment of the Court of Justice of the European Union (CJEU) of 10 September 2015 in case C-106/14 and the updated ECHA Guidance for Articles (2017).
The space sector and REACH
In 2011 an Agency-Industry REACH WG was set up, with ESA coordination, to monitor and address REACH issues affecting the space sector. This WG monitors in particular the evolution of the REACH Candidate List and Annex XIV and its impact on the space sector.
Since 2012 the REACH WG activities were put under the mandate of the Materials and Technology WG of the CTB that later transformed into the MPTB (Materials and Processes Technology Board). Eurospace monitors activities of the MPTB to enable the identification of actions requiring joint industry actions; key Eurospace member companies also participate in the regular WG meetings.
In the frame of REACH activities Eurospace liaises with the ASD REACH & Chemicals Management Working Group, ensuring appropriate information flow and coordination of actions between space and aeronautics sectors.
Together with our partners, Eurospace also follows closely the proposed evolutions of REACH and other relevant EU chemicals legislation, such as those considered under the European Commission’s ‘Chemicals Strategy for Sustainability’ of 14 October 2020.
To date, the following substances are high on the space industry agenda (the list is not exhaustive):
- Hydrazine: Managed in the frame of the Hydrazine Task Force (HTF). The substance has been included as SVHC in the REACH Candidate List in 2011. Following an in-depth analysis involving all relevant space sector stakeholders Eurospace presented an Authorisation Exemption Position Paper for propellant-related uses to the European Commission in October 2012. A clarification by the European Commission is expected at the latest, if and when Hydrazine would be prioritised for Annex XIV. In 2019, other liquid propellants (namely MMH, UDMH and NTO/MON-x) were also included in the Task Force scope. An updated position paper was issued in April 2020.
- Chromates, especially Chromium Trioxide: Managed by the Space Chromates Task Force (STF). STF has prepared a joint Analysis of Alternatives and Socio-Economic Analysis for the use of Chromium Trioxide in chromic (or chemical) conversion coating (CCC) and the repair or maintenance of such coating on aluminium alloy parts used in launchers and space vehicles. A summary of these analyses has been submitted to the ECHA in 2015 in order to support an upstream application for authorisation (“CTACSub”); subsequently STF has been monitoring the decision-making in the case CTACSub. Following the Commission’s authorisation decision of 18 December 2020 Eurospace has published a compliance guideline for EU/EEA downstream users.
- N-Methyl-2-Pyrrolidone (NMP) – This substance was identified as an SVHC in the REACH Candidate List in 2011. Subsequently a restriction procedure was initiated. In 2017 ECHA decided to review the situation and NMP could now also be subject to authorisation (inclusion on Annex IV). This is a subject for serious concern for our industry. On 9 May 2020 a new restriction (entry 71 of REACH Annex XVII) on the manufacture, placing on the market and use of NMP to ensure that the exposure of workers remains below specified maximum levels entered into application.
- Metallic Lead (Pb): The substance is used in space systems. The major use of concern is in: Tin-Lead soldering for electronics. Lead has been included in the SVHC Candidate List in June Since March 2018 Eurospace has been supporting the MPTB for the set-up of the Lead Task Force(LTF) addressing lead-related issues for the space sector and advocacy in the REACH process. In 2020 a Space case study on lead has been published as part of the cross-sectoral “Lead Matters” campaign.
- Diisocyanates: Diisocyanates for production of polyurethanes are used in the European Space Sector for a variety of applications (e. g. cryogenic foams). In August 2020 a new restriction (entry 74 of REACH Annex XVII) on the placing on the market and use of diisocyanates entered into force; it requires adequate training before industrial and professional use as from 24 August 2023.
- Propellants and explosives (energetic materials): Managed in the frame of the Energetic Materials Working Group (EMWG). The EMWG is a long-term collaboration of industry and agencies to monitor and take the required actions to determine and mitigate possible regulatory obsolescence risks – mainly but not limited to the REACH – for substances used in energetic materials for space applications. The list of energetic materials currently being monitored comprises more than 50 entries, going beyond the liquid propellants subject to the Hydrazine Task Force to also include other essential propellants and explosives, such as ammonium perchlorate, hexogen “RDX”, hydrogen peroxide and lead azide.
In the medium term, other substances may be prioritised by REACH with potential concerns for the space sector; examples include:
- Perchloric acid,its salts and precursors (used as oxidiser in solid propulsion systems: e.g. Ariane and Vega main propulsion)
- Boric Acid
- Borates (crystals, lasers, optical instruments)
- Gallium Arsenide (GaAs – solar generators, EEE components)
- Nickel derivates (surface treatment, energy storage)
- Bisphenol-A (BPA) (Used in Epoxy resins)
In terms of magnitude, ~8% of the materials used in the space industry may be affected in the mid-term, and possibly 20% in the long-term, based on analysis of the REACH Candidate List for authorisation and relevant precursor lists. These high numbers show the significant potential impact of the REACH chemicals regulation on the space sector, which was not a primary target of these rules.
SCIP notification
In addition, the sector is working on the application aspects of the revised Waste Framework Directive 2008/98/EC (WFD):
- Article 9 of the revised WFD foresees a notification requirement for EU article suppliers as from 5 January 2021 and creation of a corresponding database on ‘Substances of Concern in Products’ (SCIP) by ECHA for articles containing substances included in the REACH Candidate List above 0.1% weight by weight. ECHA shall provide access to that database to waste treatment operators, but is even planning to publish it. Products sent into space and related means of transport such as launch vehicles typically do not result in waste on the EU territory. Therefore, such products are not part of the Circular Economy and appear to fall outside the scope of the WFD. Yet, an explicit exemption is not foreseen for such products, and information disclosure in ECHA’s SCIP database would raise serious concerns. Against this background the WFD Task Force of the European Space Sector has prepared a Best-Practice Guidance in 2020 to comply with SCIP notification, taking into account the special case of space products.
Eurospace REACH Task Forces / Working Groups
Eurospace supports the coordination and implementation of joint space industry actions in the REACH framework with dedicated Task Forces:
- EMWG – Energetic Materials Working Group
- LTF – Lead Metal Task Force
- HTF – Hydrazine Task Force (inclusive of other liquid propellants)
- STF – Space Chromates Task Force
- WFD TF – Waste Framework Directive Task Force
The REACH Task Forces are led by Pierre Lionnet (Research Director).
All REACH activities of the space industry are coordinated with the Materials and Processes technology Board, managed by ESA. They are technically supported by REACHLaw.
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