LEARNING FROM THE REGISTRATION EXPERIENCE OF A SME. Fabio Stratta Technical Director, Giusto Faravelli SpA fabio.stratta@faravelli.



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LEARNING FROM THE REGISTRATION EXPERIENCE OF A SME Fabio Stratta Technical Director, Giusto Faravelli SpA fabio.stratta@faravelli.it

FARAVELLI GROUP Giusto Faravelli Spa Milan, Italy Hamburg Prague Barcelona Beijing New York DISTRIBUTION/IMPORT COMPANY WHAT YOU CAN LEARN FROM OUR REGISTRATION EXPERIENCE IS WHAT THE REGISTRATION EXPERIENCE ITSELF HAS TAUGHT US

OUR CURRENT STATISTICS IN REACH Purchases 40% 60% from EU suppliers from EXTRA-EU suppliers Sales 20% 80% REACH relevant fields EXEMPT fields Sales covered by Our pre-registrations Our registrations 88% 8% 4% Other fields of application= further regulatory compliance= furthercustomers requests= [ ] Supplier's pre-registrations/registrations

FIRST CONSORTIUM EXPERIENCE CopperCompoundConsortium(CCC) Secretariat hold by: Regulatory Compliance Limited(Head Office in Edinburgh). one year hazardousness > 1000 tons/year 30 members VERY POSITIVE EXPERIENCE forus... Importer No data owned Difficulties with Extra-EU suppliers data

FURTHER REGISTRATIONS: Synthesis intermediate Full registration of a hazardous substance (CCC) Full registration of a nonhazardous substance Called-off project Consortium in progress Several gaps with extra-ue suppliers (seeforward) BUSINESS LOST Missed registrations can still be a learning opportunity!!

LESSON N 1: Registration Time Most demanding registration(>1000 tons/year) 1 year Lessdemandingregistration(non-hazardoussubstance) 4 months Average time Bearable if you have to register one substance/year Efficienttimemanagement isthe first factortoconsider.. especially with 2018 drawing closer huge number of substances to be registered

LESSON N 2: Costs LoAprice couldbeveryhigh Howcan wecheck thatcostsare fair? IsREACh manager ableto evaluatethe financialside of registration? Isaccounting / finance dept. expert in REACH regulation?? HOW TO SAVE MONEY? Secretariat as a key player Using QSARs or Read-across Meeting as an investment? what in 2018 when there will be n-registrations = n-meetings?

LESSON N 3: EXTRA-EU suppliers There are lots of pre-registrations buthowmanyofthosewillend in a registration? WHAT CAN WE DO?? Start registering all substances? BUTiftheyregisterittooyouwillhavewastedmoney? An importeralwayshastopayfordata Wait and see? BUTthenitcouldbetoolate.. A gooddecisioncan onlybemadebyknowingwellyoursupplierand building firm relationships with your own communication skills (see after)

LESSON N 4: Informatics IUCLID is seen as a great hurdle for smaller companies and is even perceived as a barrier for registration. The use of a computer-powered internal tracking system to keep REACH under control is advisable, more so if you have to manage lots of different products

LESSON N 5: Communication CONSORTIUM INTERNALLY ECHA One-to-one meetings TRADE ASSOCIATIONS Expert advices controllo di tutta la documentazione

LIMITING FACTORS lots of substances to be registered dedicatedstaff developmentofit systems trainings urban legends end use inquiries and e-sds registration intent inquiries to suppliers reminders lack of REACH knowledge At least one, fully dedicated person is required tomanageand keep REACH system under control

REACH REACH MANAGER

STEP 1: TIMELY CREATION OF REACH MANAGER ASSISTANTS? BE READY IN 2018?????

STEP 2: KNOW HOW, COMMUNICATION AND FORMATION

STEP 3: CREATION OF AN INFORMATIC SYSTEM exempt substance SALE non-exempt substance Check of customer business field exempt category non-exempt category EU supplier EXTRA-EU supplier Check of supplier information about REACH status Check of information about REACH status Substance registered/ pre-registered by supplier No information Substance registered/ pre-registered by supplier/us No information Sales unlock Sales block

STEP 4: DIALOGUE WITH ECHA FOR SIMPLIFICATION Need for strict rules about costs sharing e.g. a regulation for standardized LoA costs Support for extensive use of QSAR e Read-Across reports A new, non-mandatory simplified interface to be developed by ECHA for data entry, aimed at registration of substances between 1 and 10 t/y Avoiding sudden rule -changing (e.g. Annex IV/V; GL on Intermediates )

CONCLUSIONS REGISTRATION EXPERIENCE a fieldwork to learn how to characterize the main obstacles... and identify the most suitable strategies to overcome them MANAGING KEYS Efficient future-oriented organisation Collaboration Communication Skills Time Financial resources