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

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Doris Josephine Harmon
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1 LEARNING FROM THE REGISTRATION EXPERIENCE OF A SME Fabio Stratta Technical Director, Giusto Faravelli SpA [email protected]

2 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

DISTRIBUTION/IMPORT COMPANY WHAT YOU CAN LEARN FROM OUR

pre-registrations Our registrations 88% 8% 4% Other fields of application= further

3 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

4 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

one year hazardousness > 1000 tons/year 30 members VERY POSITIVE

5 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!!

Called-off project Consortium in progress Several gaps with extra-ue

7 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

you have to register one substance/year Efficienttimemanagement isthe first

8 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?

Isaccounting / finance dept. expert in REACH regulation?? HOW TO SAVE MONEY?

9 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)

BUTiftheyregisterittooyouwillhavewastedmoney? An importeralwayshastopayfordata Wait and see?

10 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

The use of a computer-powered internal tracking system to keep REACH

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

12 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

registration intent inquiries to suppliers reminders lack of REACH knowledge

13 REACH REACH MANAGER

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

16 STEP 2: KNOW HOW, COMMUNICATION AND FORMATION

17 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

information about REACH status Check of information about REACH status Substance registered/

18 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 )

reports A new, non-mandatory simplified interface to be developed by ECHA for data entry, aimed at

19 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

.. and identify the most suitable strategies to overcome them

Summary of questions submitted to Chemical Watch during and after K-REACH webinar on 14/5/2013

Summary of questions submitted to Chemical Watch during and after K-REACH webinar on 14/5/2013 1) Can you list three key differences between REACH, K-REACH and China REACH? EU REACH China-REACH K-REACH