1. 1 The role of the only representative Simona Fajfar

2. 2 Only representative (OR) Only representative: means a natural or legal person established in the EU and appointed by a manufacturer, formulator or producer of an article established outside the EU to fulfil the obligatioins of importers (Article 8).

3. 3 OR registration obligation Only representative established in the EU and appointed by a manufacturer, formulator or article producer established outside the EU to fulfill the registration obligation of importers

4. 4 Why to have an only representative? If you wish to export from Serbia or other non-EU country to EU and be on the market You have two options: 1.Put on EU market through Importers only 2.Appointment of Only representative

5. 5 When you have appointed OR This will relieve the EU importers within the same supply chain from their registration obligation, as they will be regarded as a down stream users.

6. 6 Importer Importer: means any natural or legal person established within the EU who is responsible for import (Article 3(11)). Import: means the physical introduction into the customs territory of the EU (Article 3(10)).

7. 7 Example Import of mixture (glu) formulated in Sebia A company x (downstream user-article producer) is needing a components for their products He has to decide ether to buy it from EU supplier or become an importer for this specific mixture

8. 8 Indentification of the role Legal entities can have more than one role Important to identify different roles You can be OR and downstream user for another substance which you are buying on a EU market Situation in Slovenia when roles are changing (it is all about costs)

9. 9 Possible tasks of the OR OR is the one who is legaly responsible in the REACH system Non-EU manufacturer is not legally responsible Obligation as a registrant to register substances as such in a mixture or in article

10. 10 Obligations of the OR regarding the registration of substances An OR is fully responsible and liable for fulfilling all obligations of importrs for the substances he is responsible for. To have in mind that OR has also other obligations of the importers under REACH.

11. 11 Obligation of the OR Pre-registration Data sharing Involment in the SIEF (Substance Information Exchange Forum) Can play an active role within SIEF. Can be involved in SIEF negotiations.

12. 12 ‘Taking care’ of imported quatities The OR registers the imported quantities depending on the contactual arrangements between the ‘non EU manufacturer’ and OR.

13. 13 Obligation of OR OR shall keep an up to date list of EU customers (importers) within the same supply chain of the non-EU manufacturer and the tonnage covered for each of this customers, as well as information on the supply of the latest update of the Safety Data Sheet.

14. 14 OR should proof to enforcement Authorities It is essential that there is clear identification of: Who in the supply chain of a substance outside EU is the manufacturer, formulator or producer of articles. Who has appointed the OR Which imports the OR has responsibility for

15. 15 Who can appoint an OR? According to Article 8(1) a ‘non-EU manufacurer’ being a natural of a legal person who is manufacturing a substance, formulating a mixture or producing an article that is imported into the EU can appoint an OR to fulfil the registration obligaton for importers. Non- EU distributors are not mentioned in this article and therefore can not appoint OR

16. 16 Who can not appoint an OR It should be noted that a non-EU distributor is not a distributor for the purposes of REACH as he is not a natural or legal person established in the EU. An EU based distributor cannot appoint an OR.

17. 17 How to choose the “right” OR Someone you can have a good businees relation ship Enough of experience: Knowing the legislation, also legal and economic knowledge It might me a team who knows what are they are doing Easy to communicate with

18. 18 Contract beetwen non-EU manufacturer and OR A clause what happen when your status change and Serbia is becoming part of EU Who is the owner of registration?

19. 19 How to change the OR? The change should be easy to do Written in a contract between OR and non- EU manufacturer You need a good lawyer to have a good contact The reality of REACH is that many things are legal (good legal advise in needed and a other skills)

20. 20 If you decide to change the OR? If a non EU manufacturer decides to change his OR, the succesor will have to update the information related to the legal entity provided to ECHA.It is recommended that the new only representative submit evidence of his appointment and of agreement of the earlier OR to this change.This to include in as a clause of the contact.

21. 21 How to avoide possible problems in practice When we can expect problems in practice with OR? -Contact -Enough experience from the side of OR -Also OR can have problems -It is also about good business relationship -It is about partnership /they both loose

22. 22 Obligation to communicate down the supply chain Same obligation as an importer Article 33 obligation to communicate about the substance on the candidate list Information if substance is subject to an authorisation Information about substances which fall under restriction Providing Safety Data Sheet

23. 23 REACH certificate According to legislation there is no REACH certificate But in practice they are Companies they find the way how to proof that their product is in compliance with REACH.

24. 24 SIEF

25. 25 SIEF formation All potential registrants and data holders for the same pre-registered phase in substance are participants in ‘Substance information Exchange Forum’ (SIEF). Aims of the SIEF: To facilitate data sharing for the purposes of registration Agree on classification and labelling where there is difference beetwen potential registrants

26. 26 Example 1 100 legal entities which has pre-registered a substance in 2008 0 registration in 2010 50 registration 2013 50 registration 2018 DORMANT NOW ACTION NOW 31st May 2013

27. 27 Example 2 100 legal entities which has pre-registered a substance in 2008 10 registrations 2010 40 registrations 2013 50 registration 2018 31st May 2013 Letter of Access to the data TOKEN CODE !!!

28. 28 Example 3 100 legal entities which has pre-registered a substance in 2008 0 registrations in 2010 0 registrations 2013 100 registrations 2018 ACTION STARTS IN 2016 31st May 2018

29. 29 S I E F PRE-REGISTRATION ECHA REGISTRATION at ECHA Individual registrant Lead Company CONSORTIUM Members of CONSORTIUM Individual registrant Token code Only Lead COMPANY Pridobitev manjkajočih podatkov 1. INCLUSION INTO CONSORITUM AS ASSOCIATED MEMBER 2. Complete LoA 3. Partial LoA Joint Registration - LR (LEAD REGISTRANT)

30. 30 In case several companies established outside the EU are part of the same group, and those companies export the same substance into the EU, each company consistutes a non EU manufacturer under REACH and may appoint an OR. The OR will have to submit separate registrations for each of the companies he is representing.

31. 31 HVALA