EU REACH 2018 deadline is close Act now! In-cosmetics Asia 2017 @BITEC, Bangkok, November 2nd Speaker Jani Määttä, CEO
EU Reach FACTS & GOALS REACH Registration, Evaluation, Authorisation and Restriction of Chemicals The most comprehensive chemical regulation in the world Three-phase implementation entered into force in 2007. The final deadline in the end of May 2018 From June 2018 all substances, imported to the EU/EEA more than 1 metric tonne per annum, need a full REACH registration
EU Reach FACTS & GOALS REACH registration is made to substance only In cosmetic product you need to register all substances which annual export exceeds 1 tonne Non-EU company needs an Only Representative to handle registration and take measures in information change with ECHA and distributors
EU Reach FACTS & GOALS 2018 REACH deadline figures by ECHA Total registrations to date (06/2017): 9,034 Total expected registrations: 60,000 Total substances to date (06/2017) : 4,454 Total expected substances: 25,000 European Chemicals Agency is encouraging companies to register as soon as possible to avoid "the last-minute rush REACH registration might take up to 8-10 months!
REACH as a business opportunity Full REACH registration is a major assett for placing your product on the EU market Many companies are anticipating and likely to be late with registrations Your chance to step in with fully registered product Registration of the manufacturer applies to all of your distributors in the EU/EEA. The registration of the importer applies only to this one importer
REACH Business Costs Registration contains 4 main expenses 1) Technical registration work Data search, interpretation, data gap analysis, dossier submission (Service provider) 2) Laboratory costs Substance ID, sameness testing, physico-chemical property testing, SVHC identification testing 3) European Chemicals Agency registration fee Determined by the size of the company 4) Letter of Access Fee LR/ Consortium sell the data package to compensate testing costs. Fee is based on real testing costs and full transparency REACH registration An investment!
Enforcement acts by ECHA in the EU/EEA Enforcement of REACH and CLP is a national responsibility National authorities are actively carrying out inspections to verify the compliance of duty holders regarding to the REACH regulation National Inspectorates (e.g. Finland) Occupational health and safety authority Centres for Economic Development, Transport and the Environment Municipal environmental authorities Customs Defence Forces
Enforcement acts by ECHA in the EU/EEA Noticeable sanctions brought in for disregarding compliance duties Administrative penalties Ban of sales, withdrawal from the marker, destruction of products, substantial fines Criminal penalties fines up to millions or Euros, imprisonment up to 3 yrs Information is available widely from service providers and ECHA ignorance is not applicaple reason to avoid sanctions
REACH and formulations Case study: Shampoo Mild conditioning shampoo ingredient list: Distilled water (aqua): 59% Alpha Olefin Sulphonate: 30% Polyglucose (decyl glucoside): 8% Grapeseed Oil: 1% Paraben-DU: 1% Polyquaternium: 0,5% Fragrance Citrus Punch: 0,5% Total annual export to the EU/EEA is 14,0 tonnes
REACH and formulations Case study REACH registration summary: Distilled water (aqua): - Alpha Olefin Sulphonate: 30% 4,2 tonnes Polyglucose (decyl glucoside):8% 1,12 tonnes Grapeseed Oil: 1% 0,14 tonnes (<1t/a) Paraben-DU: 1% 0,14 tonnes Polyquaternium: 0,5% 0,07 tonnes Fragrance Citrus Punch: 0,5% 0,07 tonnes Result: Full REACH registration (1-10tpa) for Alpha Olefin Sulphonate and Polyglucose
ONLY REPRESENTATIVE - Selecting a good OR Some key facts should be considered when choosing an Only Representative: Is OR appointed only to meet the legal requirements? Is OR taking care of technical registration work? If OR is your distributor, what happens when they need to co-operate with other distributors? Should OR be an independent entity which reliably covers all tasks and correspondence with you distributors and ECHA? Is OR company member of ORO?
Obligations of the Only Representative Accepts the role as OR following appointment by the supplier Sets up REACH-IT account and make substance inquiry Takes care of registration dossier updates Accepts official role in SIEFs Agrees on new testing strategies Agrees hazard assessment for single registration Agrees on data gaps Agrees on costs of sharing data
Obligations of the Only Representative Identifies and agree to co-operate with importers Considers exposure scenarios for downstream users in the supply chain Organizes Chemical Safety Report (CSR) Organizes and agree on SDSs to be consistent with Registration details Monitors supply patterns (import volumes and SDS check with each importer) Checks that risk management measures are being communicated Co-operates with authorities
Only Representative challenges A lot of unqualified OR s in the Europe Union: OR has let you / your customers down, no skills/know-how OR is not transparent, providing bad service OR doesn t serve you comprehensively OR has communication problems
Details to review when choosing an Only Representative Is the OR member of some independent organization in the EU, such as ORO? Does the OR have a CLEAR step-by-step process? Does the OR provide an ONE STOP SERVICE? Does the OR have good relations with authorities / inspectors in the EU? Does the OR show the actual certificate to the importers and customers?
REACH & ARTICLES - It may effect your company! The European Commission has stated that in 2015, more than 2,000 dangerous products triggered EU-wide alerts. A key challenge is the increasing share of products bought online from outside the EU. Which products are posing risks? In 2015, toys (27%) and clothing, textiles and fashion items (17%) were the two main product categories. Definition of an Article under REACH: an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition Examples: powder brush, hair dryer, shampoo bottle
Declaration of Compliancecertificate Document is compiled by specialist Declares all essential data of chemicals used through supply chain of the product Determines the REACH compliance of the product
Substances of Very High Concern (SVHC) Substances identified via formal process as Substances of Very High Concern (SVHC) Candidate List updated ~twice per year certain obligations apply EU Producers and importers of articles need to notify any SVHC substances in articles if It is present in the articles >1 tonne per producer/importer per year, and It is present above 0,1% weight by weight Must notify to ECHA within 6 months of the inclusion of the substance on the Candidate List or when starting import or production
Understanding CLP The Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008) CLP is the European Union s implementation of Global Harmonizing System (GHS) Applies to substances and mixtures Labels need to be in local languages One of the main aims of CLP is to determine whether a substance or mixture displays properties that lead to a hazardous classification. In this context, classification is the starting point for hazard communication.
Understanding CLP Safety Data Sheet (SDS, esds) is the core of the CLP SDS has to be authored in the nations own official language including local legislation where imported Following processes are part of CLP Harmonised classification and labelling Alternative chemical names in mixtures C&L Inventory Poison centres
FINAL SUMMARY REACH 2018 ACT NOW! Still chance to finalize registration process without serious delays (ECHA, laboratories, agencies) Not so complicated when you cooperate with experts REACH compliance gives more value for your product, also outside of the EU Be careful while appointing an Only Representative Make sure your SDS- documents and product labels are up to date
THANK YOU! Questions? Comments?