Dutch framework - assessing authorisation applications Jan Wijmenga Directorate for Environmental safety and Risks
Structure of presentation The REACH process o Registration • Evaluation • Authorisation • Restriction • o Framework assessing authorisations ECHA • NL • Ministry of Infrastructure and Water Management 2
SVHC Roadmap Compliance check Manual IT screening screening RMOA Substance evaluation No action Other legislation/ SVHC identification Harmonised actions Candidate List classification Restriction Authorisation Annex XVII entry Annex XIV entry 3 Ministry of Infrastructure and Water Management
Substances of Very High Concern (SVHC) Criteria article 57 REACH: Carcinogenic or Mutagenic or Reprotoxic cat. 1A or 1B conform CLP regulation Persistent, bioaccumulating and toxic (PBT, Annex XIII), or very Persistent and very Bioaccumulating (vPvB) Equivalent Level of Concern (for example sensitizers, STOT RE, endocrine disrupters, persistent and mobile subst.) Ministry of Infrastructure and Water Management 4
REACH Annex XIV Authorisations. Objective: 1) substitution and 2) safe use Use of substance in EU is not permitted after ‘ sunset date’, unless authorisation is granted ➢ or application is submitted in time and no decision ➢ taken yet -> does not cover (imported) articles, only use in or placing on market in EU Exemptions: see http://echa.europa.eu/applying-for-Authorisation Ministry of Infrastructure and Water Management 5
Procedure application of authorisation Ministry of Infrastructure and Water Management 6
1. Opinions of ECHA committees: • Risk Assessment Committee (RAC) • Socio-Economic Analysis Committee (SEAC) 2. Commission draft decision 3. Discussion in REACH committee 4. Vote and then... Ministry of Infrastructure and Water Management 7
Ministry of Infrastructure and Water Management
Framework for assessing authorisation decisions Authorisation can be granted when: 1. risks are adequately controlled, 2. use is necessary for socio-economic reasons and no suitable alternatives are available Ministry of Infrastructure and Water Management 9
Framework for assessing authorisation decisions A balance between risks and socio-economic benefits ☺☺ Risk mitigation ☺☺ measures €€ €€ €€ €€ €€
Exposure / Risk limits NL policy Exposure of consumers: no authorisation Risk to workers: adequate control should be demonstrated Example: Remaining cancer risk > 4 * 10 -3 No support for authorization, as RAC could not conclude that risk mitigation measures sufficiently reduced risk Risk to environment: case by case assessment. Ministry of Infrastructure and Water Management 11
Time period granted NL follows period proposed in RAC / SEAC opinion, usually 4-7-12 years, unless ➢ Alternatives insufficiently assessed (indication: minority positions in RAC/SEAC) ➢ Authorisation is for non-essential uses Ministry of Infrastructure and Water Management 12
To take home ➢ DATA! ➢ Exposure assessment, ➢ risk mitigation measures, ➢ alternatives; Wealth of info available at ECHA’s website: ➢ https://echa.europa.eu/applying-for-authorisation Ministry of Infrastructure and Water Management 13
Thank you for your attention Ministry of Infrastructure and Water Management 14 14 October 2019
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