Authorisation is<strong>the</strong> decathlon amongst<strong>the</strong> Reach processesThe “a” <strong>in</strong> “Reach”, <strong>the</strong> European Union’s Regulation on <strong>chemical</strong>s, stands forauthorisation. It targets <strong>the</strong> most hazardous <strong>chemical</strong>s, so-called “Substances of VeryHigh Concern” (SVHC), and aims at <strong>the</strong>ir progressive replacement with suitable saferalternatives.Authorisation is arguably <strong>the</strong> most ambitious, politically charged and effectiveprocess under Reach, as it forces big and small companies throughout Europe <strong>in</strong><strong>the</strong> <strong>chemical</strong> and metals <strong>in</strong>dustry and various downstream sectors—such as <strong>the</strong>aerospace, automotive, and sanitary <strong>in</strong>dustry—to review <strong>the</strong>ir <strong>chemical</strong>s portfolio,identify and remove SVHC from <strong>the</strong>ir products, f<strong>in</strong>d new technologies, and makestrategic decisions for <strong>the</strong>ir future operations.REACHTim BeckerFrom a distance <strong>the</strong> authorisation systemunder Reach looks ra<strong>the</strong>r clear. In a firststep, <strong>the</strong> substance is <strong>in</strong>cluded <strong>in</strong> <strong>the</strong>candidate list by <strong>the</strong> European ChemicalsAgency (Echa) and thus formallyidentified as SVHC, follow<strong>in</strong>g proposalby a Member State or Echa itself uponrequest of <strong>the</strong> European Commission.In a second step, Echa recommendssubstances from <strong>the</strong> candidate list for<strong>in</strong>clusion <strong>in</strong> <strong>the</strong> authorisation list (AnnexXIV to Reach) by <strong>the</strong> Commission.In a third step, companies apply forauthorisation by <strong>the</strong> “latest applicationdate”, if <strong>the</strong>y wish to use or place on<strong>the</strong> market an Annex XIV substance foruse after <strong>the</strong> “sunset date”. Both datesare specified <strong>in</strong> Annex XIV for eachsubstance.The application is submitted to Echa,whose Committees for Risk Assessment(RAC) and Socio-economic Analysis(SEAC) elaborate op<strong>in</strong>ions to <strong>the</strong>European Commission for decisionmak<strong>in</strong>g.In practice however, <strong>the</strong> authorisationprocess has a significant number ofuncerta<strong>in</strong>ties, which make it verychalleng<strong>in</strong>g for companies to decide on<strong>the</strong> appropriate way forward for <strong>the</strong>irbus<strong>in</strong>ess:Will my <strong>chemical</strong> be proposed for <strong>the</strong>candidate list? Will it also eventually be<strong>in</strong>cluded <strong>in</strong> Annex XIV and what will be<strong>the</strong> sunset date? Do I need to apply forauthorisation? What is <strong>the</strong> timeframe forall <strong>the</strong>se activities? What are <strong>the</strong> costsand prospects of my application? Whatshould be my application strategy? Howlong will <strong>the</strong> authorisation be valid?There is no clear answer to any of<strong>the</strong>se fundamental questions beforehand,and only a detailed understand<strong>in</strong>gof <strong>the</strong> authorisation provisions, <strong>the</strong>irapplication by Member States, Echa and<strong>the</strong> Commission, and expert judgmentThe authorisation processhas a significant number ofuncerta<strong>in</strong>ties, which makeit very challeng<strong>in</strong>gfor companies to decide on<strong>the</strong> appropriate way forwardfor <strong>the</strong>ir bus<strong>in</strong>ess.will help companies make <strong>the</strong> rightdecisions. Some key questions shall beaddressed hereafter.Will my <strong>chemical</strong> beproposed for <strong>the</strong> list?Reach Article 57 lists a <strong>chemical</strong>’sproperties, which may trigger itsidentification as SVHC <strong>in</strong> <strong>the</strong> candidatelist.The classification as category 1A or1B carc<strong>in</strong>ogenic, mutagenic or toxicto reproduction (CMR) accord<strong>in</strong>g toRegulation (EC) No 1272/2008 (CLP)has been used mostly by Member Statesand <strong>the</strong> European Commission so far.The legally b<strong>in</strong>d<strong>in</strong>g harmonisationof <strong>the</strong>se classifications <strong>in</strong> Annex VI toCLP makes SVHC proposals based onCMR properties straightforward andmay <strong>the</strong>refore be used by companiesas one <strong>in</strong>dicator for potential candidatesubstances.In addition, authorities are more andmore propos<strong>in</strong>g 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 <strong>the</strong> environment to<strong>the</strong> aforementioned substances, such asendocr<strong>in</strong>e disruptors.The SIN (Substitute It Now) listpublished by <strong>the</strong> Swedish NGO ChemSec,<strong>the</strong> International Chemical Secretariat,is a useful shortlist of substances, whichmay be proposed for <strong>the</strong> candidate list. Itcurrently lists 626 <strong>chemical</strong>s, compar<strong>in</strong>gto close to 150 candidate list entries at<strong>the</strong> moment.The European Commissioner forEnvironment Janez Potočnik announced<strong>in</strong> a speech at <strong>the</strong> Hels<strong>in</strong>ki ChemicalsForum <strong>in</strong> May 2011 that <strong>the</strong> SIN listshould <strong>in</strong>dicate to <strong>in</strong>dustry <strong>the</strong> substances<strong>the</strong> European Commission will take<strong>in</strong>to consideration for placement on <strong>the</strong>candidate list.28 KEMIA 5/2013
ScanstockphotoThe decathlon consists of 110 metrehurdles and n<strong>in</strong>e o<strong>the</strong>r events. TheReach authorisation is an equallylong and demand<strong>in</strong>g process.5/2013 KEMIA29
Change language