in the Finnish chemical industry - Kemia-lehti

Authorisation isthe decathlon amongstthe Reach processesThe “a” in “Reach”, the European Union’s Regulation on chemicals, stands forauthorisation. It targets the most hazardous chemicals, so-called “Substances of VeryHigh Concern” (SVHC), and aims at their progressive replacement with suitable saferalternatives.Authorisation is arguably the most ambitious, politically charged and effectiveprocess under Reach, as it forces big and small companies throughout Europe inthe chemical and metals industry and various downstream sectors—such as theaerospace, automotive, and sanitary industry—to review their chemicals portfolio,identify and remove SVHC from their products, find new technologies, and makestrategic decisions for their future operations.REACHTim BeckerFrom a distance the authorisation systemunder Reach looks rather clear. In a firststep, the substance is included in thecandidate list by the European ChemicalsAgency (Echa) and thus formallyidentified as SVHC, following proposalby a Member State or Echa itself uponrequest of the European Commission.In a second step, Echa recommendssubstances from the candidate list forinclusion in the authorisation list (AnnexXIV to Reach) by the Commission.In a third step, companies apply forauthorisation by the “latest applicationdate”, if they wish to use or place onthe market an Annex XIV substance foruse after the “sunset date”. Both datesare specified in Annex XIV for eachsubstance.The application is submitted to Echa,whose Committees for Risk Assessment(RAC) and Socio-economic Analysis(SEAC) elaborate opinions to theEuropean Commission for decisionmaking.In practice however, the authorisationprocess has a significant number ofuncertainties, which make it verychallenging for companies to decide onthe appropriate way forward for theirbusiness:Will my chemical be proposed for thecandidate list? Will it also eventually beincluded in Annex XIV and what will bethe sunset date? Do I need to apply forauthorisation? What is the timeframe forall these activities? What are the costsand prospects of my application? Whatshould be my application strategy? Howlong will the authorisation be valid?There is no clear answer to any ofthese fundamental questions beforehand,and only a detailed understandingof the authorisation provisions, theirapplication by Member States, Echa andthe Commission, and expert judgmentThe authorisation processhas a significant number ofuncertainties, which makeit very challengingfor companies to decide onthe appropriate way forwardfor their business.will help companies make the rightdecisions. Some key questions shall beaddressed hereafter.Will my chemical beproposed for the list?Reach Article 57 lists a chemical’sproperties, which may trigger itsidentification as SVHC in the candidatelist.The classification as category 1A or1B carcinogenic, mutagenic or toxicto reproduction (CMR) according toRegulation (EC) No 1272/2008 (CLP)has been used mostly by Member Statesand the European Commission so far.The legally binding harmonisationof these classifications in Annex VI toCLP makes SVHC proposals based onCMR properties straightforward andmay therefore be used by companiesas one indicator for potential candidatesubstances.In addition, authorities are more andmore proposing substances as SVHCwhich are persistent, bioaccumulativeand toxic (PBT), very persistent and verybioaccumulative (vPvB) or which giverise to an equivalent level of concernfor human health or the environment tothe aforementioned substances, such asendocrine disruptors.The SIN (Substitute It Now) listpublished by the Swedish NGO ChemSec,the International Chemical Secretariat,is a useful shortlist of substances, whichmay be proposed for the candidate list. Itcurrently lists 626 chemicals, comparingto close to 150 candidate list entries atthe moment.The European Commissioner forEnvironment Janez Potočnik announcedin a speech at the Helsinki ChemicalsForum in May 2011 that the SIN listshould indicate to industry the substancesthe European Commission will takeinto consideration for placement on thecandidate list.28 KEMIA 5/2013