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

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

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

Enforcement of CLP and REACH Regulations in Lithuania Environmental Protection Agency

REACH & CLP ENFORCEMENT SYSTEM Environmental Protection Agency

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

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 2011-2012. 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

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

Total number of inspections Environmental Protection Agency

Total number of infringements Environmental Protection Agency

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

Lithuanian national REACH-CLP helpdesk Environmental Protection Agency

Legal background Governmental Resolution of 11 July 2007 and Joint Ministerial order of 1 October 2007 No D1-500/V-781 Art. 121 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

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

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

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

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

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

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

Classification issues Environmental Protection Agency

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

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

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

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 (emails, 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

Thank you for your attention! Environmental Protection Agency