1. Chemical substances self – classification issues Lithuanian approach
23 October, 2013
Otilija Grincevičiūtė
Deputy Head
Chemical substances division
Environmental protection agency
Environmental Protection Agency

2. Content of the presentation
Enforcement of CLP and REACH Regulations in Lithuania
Lithuanian national REACH-CLP helpdesk
Classification issues
Environmental Protection Agency

3. Structure chart of Environmental protection agency (EPA)
REACH-CLP Helpdesk
REACH and CLP Enforcement
Environmental Protection Agency

4. Enforcement of CLP and REACH Regulations in Lithuania
Environmental Protection Agency

5. REACH & CLP ENFORCEMENT SYSTEM
Environmental Protection Agency

6. Legal acts enforced by EPA Chemical Substances Division
EU Legal acts
Regulation No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH);
Regulation No 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP);
Directives 67/548/EEC, 1999/45/EC – Classification, packaging and labeling of substances and preparations;
National requirements
The chemical substances accounting summary;
Data and information submission about the chemical substances and mixtures to EPA.
Environmental Protection Agency

7. Environmental Protection Agency
Types of controls
Planned – the list of companies after Risk assessment;
Triggered by different causes (e.g. complaint, information from other controlling bodies);
Projects:
REF2
- obligations of downstream users / formulators;
- 26 companies were inspected in the period of
REF3
- Registration obligations (manufacturers, importers, only representatives (OR));
- Cooperation with customs for identification of importers and importers covered by an OR;
- inter-institutional seminar for REF3 preparation was organized on 12 of February 2013;
- On site inspections were started on 28-th of March 2013.
Environmental Protection Agency

8. Environmental Protection Agency
Total number of duty-holders with duties under REACH and CLP Regulations
Environmental Protection Agency

9. Total number of inspections
Environmental Protection Agency

10. Total number of infringements
Environmental Protection Agency

11. Checklists for inspections
5 checklists on the legislative compliance of chemical substances and mixtures were developed and approved during the year of 2012.
Checklists were prepared for:
- manufacturer;
importer;
distributor;
downstream user;
only representative.
Environmental Protection Agency

12. Lithuanian national REACH-CLP helpdesk
Environmental Protection Agency

13. Legal background Governmental Resolution of 11 July 2007
and
Joint Ministerial order of 1 October 2007 No D1-500/V-781
Art of REACH regulation
and
Art. 43 of CLP regulation
Ministry of Environment
Ministry of Economy
Lithuanian REACH and CLP Competent Authority - Environmental Protection Agency in close co-operation with the Public Health Center/Ministry of Health.
Environmental Protection Agency

14. REACH-CLP helpdesk activities (1)
According to REACH (art. 124(2)) and CLP (art. 44) Regulations REACH-CLP Helpdesk provides advice and assistance on REACH and CLP obligations.
WHO applies?
manufacturers,
importers,
downstream users and
any other interested parties (e.g. other Institutions, Consultation Companies etc.)
LT Companies EU Companies non EU Companies
Environmental Protection Agency

15. REACH-CLP helpdesk activities (2)
Telephone
(Call center)
Official letter
Difficult questions:
HELPEX
Help from other LT Institutions
face-to-face consultations
Environmental Protection Agency

16. REACH-CLP helpdesk consultations
2010
2011
2012
2013 (I-II Q)
Telepphone
601
500
305
153
E.mail/Official letter
200
121
124 54
Face-to-face consultations 16 5 9 3
Provide information:
on the provisions of REACH and CLP regulations;
on certain aspects of enforcement;
about other national legislations concerning management of chemical substances and mixtures.
Environmental Protection Agency

17. REACH-CLP helpdesk activities (3)
REACH-CLP information events
(seminars, training...)
Information leaflets
2007 – 2013 I-II Q  15
Newsletters
2007 – 2013 I-II Q  22
6 - CLP
17 - REACH
5 - CLP
Environmental Protection Agency

18. The total amount of questions in Lithuanian REACH-CLP helpdesk
Environmental Protection Agency

19. REACH & CLP Helpdesk information events
„Classification, labelling and packaging of chemical substances and other legislation“ (2009)
„Classification and labelling notification submission to ECHA inventory and safety data sheets“ (2010)
“Classification of mixtures“ (Ministry of Environment) (2011)
„Classification & labelling of mixtures under CLP regulation“ - in collaboration with BEF (2012)
Environmental Protection Agency

20. Classification issues
Environmental Protection Agency

21. Environmental Protection Agency
Sources which are used to identify the correct classification of the substance:
Annex VI of CLP regulation;
Classification and labelling (C&L) inventory;
Environmental Protection Agency's chemical database;
Scientific literature;
Visual - logical aspects;
etc.
Environmental Protection Agency

22. Classification of chemical substances: enforcement challenges
If classification is provided by a non-EU manufacturer on the basis of carried out tests, this classification often do not coincide with the harmonized classification;
Many of chemicals do not have a harmonized classification;
There is no capacity to perform an independent test in accredited laboratory to verify classification;
Lack of knowledge and practices in classification:
particularly in the classification of chemicals which are hazardous to the environment;
Too complicated classification system (classification of mixtures);
Lack of data on the carried out tests;
Undefined legal responsibility for inaccurate / incorrect classification;
Difficult to verify the classification during the physical inspection in the workplace.
Environmental Protection Agency

23. Environmental Protection Agency
Feedback from the operators after incorrect chemical classification in SDS was recorded
First inspectors indicate inconsistencies between the submitted classification in SDS and harmonized classification;
Manufacturers / importers / only representatives are obliged to check the classification in SDS and if necessary to reclassify;
SDS with the correct classification supposed to be transferred in the supply chain in both directions;
Downstream users and distributors are obliged to formally inform about the incorrect classification its suppliers (Manufacturers / importers / only representatives);
Operators inform the competent authority about corrected classification.
Environmental Protection Agency

24. Environmental Protection Agency
Conclusions
The Environmental Protection Agency (EPA) is the main enforcing as well as competent authority for REACH and CLP within Lithuania;
There are less infringements in recent years because of awareness raising during seminars, consultations ( s, telephone, face – to face), leaflets, brochures, EPA website; due to small SDS or classification non-compliance usually verbal or written advice is given;
CLP annex VI and C&L inventory are very relevant for enforcement activities.
Environmental Protection Agency

25. Thank you for your attention!
Environmental Protection Agency