REACH Authorisation. REACH Conference Bratislava September 3-4, 2018

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1 REACH Conference Bratislava September 3-4, 2018 REACH Authorisation Martin Murín, MSc. Ekotox Centers Ekotoxikologické centrum Bratislava s.r.o. Tomášikova 10/F, Bratislava Tel/Fax.: / ekotox@ekotox.eu

2 REACH REGULATION (EC) No 1907/2006 (21) Although the information yielded on substances through evaluation should be used in the first place by manufacturers and importers to manage the risks related to their substances, it may also be used to initiate the authorisation or restrictions procedures under this Regulation or risk management procedures under other Community legislation. Therefore it should be ensured that this information is available to the competent authorities and may be used by them for the purpose of such procedures. (22) The authorisation provisions should ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled. Authorisations for the placing on the market and use should be granted by the Commission only if the risks arising from their use are adequately controlled, where this is possible, or the use can be justified for socioeconomic reasons and no suitable alternatives are available, which are economically and technically viable. Martin Murín, Ekotox Centers

3 REACH REGULATION (EC) No 1907/2006 (77) In view of workability and practicality considerations, both as regards natural or legal persons, who have to prepare application files and take appropriate risk management measures, and as regards the authorities, who have to process authorisation applications, only a limited number of substances should be subjected to the authorisation procedure at the same time and realistic deadlines should be set for applications, while allowing certain uses to be exempted. Substances identified as meeting the criteria for authorisation should be included in a candidate list for eventual inclusion in the authorisation procedure. Within this list, substances on the Agency's work programme should be clearly identified. Martin Murín, Ekotox Centers

4 REACH Authorisation SVHC Identification Candidate List Recommendation for the Authorisation List Inclusion into Authorisation List (Annex XIV) Applications for Authorisation Martin Murín, Ekotox Centers

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7 The route to authorisation a Member State or ECHA, at the request of the Commission, proposes a substance to be identified as an SVHC. Substances with the following hazard properties may be identified as SVHCs: Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B in accordance with the CLP Regulation. Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vpvb) according to REACH Annex XIII. Substances on a case-by-case basis, that cause an equivalent level of concern as CMR or PBT/vPvB substances. Martin Murín, Ekotox Centers

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9 Candidated List Article 59 Identification of substances referred to in Article The procedure set out in paragraphs 2 to 10 of this Article shall apply for the purpose of identifying substances meeting the criteria referred to in Article 57 and establishing a candidate list for eventual inclusion in Annex XIV. The Agency shall indicate, within this list, the substances that are on its work programme according to Article 83(3)(e). Martin Murín, Ekotox Centers

10 CL / AL REACH Authorization June 2008: ECHA received its first 17 Annex XV dossiers (all from MSs) 16 passed the accordance check : public consultation : MSC agreed on 14 substances (+ 1 automatically selected because of no comment received) : 1st Candidate List officially adopted and published (15 substances) 191 entries in August 2018??? ??? 2020 = all SVHCs??? ??? Martin Murín, Ekotox Centers

11 CL / AL REACH Authorization, August 2018 Candidate List of substances of very high concern for Authorisation (published in accordance with Article 59(10) of the REACH Regulation) entries List of sustances included in Annex XIV of REACH ("Authorisation List"). Last updated 25 July unique substances/entries. Martin Murín, Ekotox Centers

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13 Submitted recommendations The REACH Regulation requires that ECHA recommends from the "Candidate List" priority substances for inclusion in Annex XIV of REACH (the "Authorisation List") and for these substances proposes Annex XIV entries (i.e. transitional arrangements and, where relevant, exemptions and review periods) to the European Commission, taking into account the opinion of the Member State Committee. Candidate List Substances Authorisation List for Annex XIV The European Commission finally decides, by "comitology" procedure (with scrutiny), which substances will be included in Annex XIV and what the associated entries will be. Martin Murín, Ekotox Centers

14 ECHA's draft or final recommendations for inclusion of Candidate List substances in Annex XIV. "Status"- column indicates whether the substances have been recommended for inclusion or are already included in Annex XIV. Documents relevant for the recommendations can be found by clicking on the "Details" next to the substances. Substances not recommended in a given round (Status: Not recommended in this round ) are re-assessed in subsequent rounds. Therefore, it is advisable to search the table by substance (Name/EC/CAS) to capture the most up-to-date status. Martin Murín, Ekotox Centers

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16 Registry of SVHC intentions Member States or ECHA, on request of the European Commission, may propose a substance to be identified as a substance of very high concern (SVHC) by preparing a dossier in accordance with the requirements set out in Annex XV to REACH. Martin Murín, Ekotox Centers

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19 Applications for authorisation process Martin Murín, Ekotox Centers

20 Latest application dates and sunset dates The sunset date is the date after which the placing on the market and the use of a substance is prohibited unless an authorisation is granted to the user. The latest application date (LAD) is the date by which the authorisation application must be received by ECHA if the applicant wishes to cont ECHA has established specific submission windows for substances with the same LADs and these submission dates can be found on ECHA s website. Martin Murín, Ekotox Centers

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26 Substances subject to authorization under REACH regulation relevant for human health

27 Probable EDC causation for IQ loss and associated intellectual disability, autism, ADHD, obesity, diabetes, cryptorchidism, male infertility Associated lifetime costs cases/y procedures/y There is a substantial probability of very high disease costs across the life span associated with EDC exposure in the EU. Estimation - the median 157 billion cost/y = approx. 1/6 th of the 798 billion European cost of brain disorders in 2010 and 1.23% of GDP. Regulatory action to limit exposure... likely to produce substantial economic benefits. Tresande L et al., J clin Endocrinol Metab., 2015, 100(4):

28 Revelance of exposure for human population Name Occupational E Consumer E E via Environment 1,2-dichloroethane (EDC) 2,2'-dichloro-4,4'-methylenedianiline (MOCA) 2,4-dinitrotoluene (2,4-DNT) 1 local site 4,4 - Diaminodiphenylmethane (MDA) Medical devices? Drinking water and fish Acids generated from chromium trioxide and their oligomers Water based paints, laboratory chemicals Chromic acid Oligomers of chromic acid and dichromic acid Dichromic acid Arsenic acid Drinking water Diarsenic pentaoxide? Diarsenic trioxide? Dichromium tris(chromate) Formaldehyde, oligomeric reaction products with aniline Pentazinc chromate octahydroxide Potassium hydroxyoctaoxodizincatedichromate Strontium chromate Trichloroethylene Spot cleaners Chromium trioxide Treated wood Around the source Potassium chromate Lead chromate Lead chromate molybdate sulfate red? Lead sulfochromate yellow Ammonium dichromate Around the source Potassium dichromate Around the source Sodium chromate Around the source Sodium dichromate Around the source Benzyl butyl phthalate (BBP) Adults AND children Bis(2-ethylhexyl) phthalate (DEHP) Adults, children + patients Bis(2-methoxyethyl) ether Vehicle emisions, drink water Dibutyl phthalate (DBP) Cosmetics, cellophane Diisobutyl phthalate (DIBP) Tris(2-chloroethyl) phosphate Products cont. FR Source: Annex XV Reports

29 REACH Review 2018 Authorisation The authorisation requirements could be harming the competitiveness of EU companies because articles imported to the EU are exempt from the authorisation obligations. A better coordination and synchronisation of actions when enacting authorisation and restriction could further improve implementation. Martin Murín, Ekotox Centers

30 REACH Authorisation?Will be EU market most innovative? Push out the worst of chemicals? What is priority - protection of EU workers or general public / consumers or the environment? EU Production vs Import of goods with SVHCs? Time, cost and effort vs benefits?