NATIONAL SANITARY VETERINARY AND FOOD SAFETY AUTHORITY BUCHAREST, ROMANIA

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1 NATIONAL SANITARY VETERINARY AND FOOD SAFETY AUTHORITY BUCHAREST, ROMANIA IMPLEMENTATION IN NATIONAL LEGISLATION OF THE DIRECTIVE 2010/63/EU ON THE PROTECTION OF ANIMALS USED FOR SCIENTIFIC PURPOSES Dr.Ioana HRISTESCU Al V-lea Simpozion Național ARSAL Noiembrie 2016 Bucuresti

2 BACKGROUND 1. National Sanitary Veterinary and Food Safety Authority Competent Authority in Animal Welfare Field 2. Abrogated and current legislation 3. Implementation of the Directive at EU level, European Commission key role 4. Implementation into the national legislation of the Directive 5. Conclusions

3 NATIONAL SANITARY VETERINARY AND FOOD SAFETY AUTHORITY

4 ABROGATED LEGISLATION 1. Council Directive no. 609 of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. 2. Ordinance no.37/ regarding the protection of animals used in scientific or other experimental purposes. 3. Law no. 471/ on the approval of the Ordinance Government no. 37/2002 on the protection of animals used in for scientific or other experimental purposes. 4. NSVFSA Order no. 84/2005 for the approval of sanitary veterinary Norm which sets up an Advisory Committee on the protection of animals used for experimental and other scientific purposes

5 CURRENT LEGISLATION 1. Directive 2010/63/EU of European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes; 2. Law no. 43/2014 regarding the protection of animals used in scientific purposes; 3. Law no. 96/2015 for modification of Annex III of the Law no. 43/2014 regarding the protection of animals used in scientific purposes; 4. NSVFSA Order no. 97/2015 to approve the sanitary veterinary norms for the authorization users, breeders and suppliers for animals used for scientific purposes and for approving the sanitary veterinary norm for authorization of the projects that use animals in procedures; 5. NSVFSA Order no. 106/2016 setting up the National Committee for the protection of animals used for scientific or educational.

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7 Actions performed by the NSVFSA in order to implement Directive provisions Suplimentary legislation: * 2 NSVFSA Orders published in Official Journal; NSVFSA Order no. 97/2015 regarding the authorisation of breeders, users, and suppliers and the authorisation of projects that use animals in procedures; NSVFSA Order no. 106/2016 setting up the National Committee for the protection of animals used for scientific or educational. * 2 drafts in order to implement the provisions of art. 23 (competence of personnel) and art. 33 (accomodation and care) from Directive.

8 Actions performed by the NSVFSA in order to implement Directive provisions Trainings with personnel from breeders, users and suppliers units and with veterinarians, held between January- February 2016 in Bucharest, Iași and Cluj Napoca. 3. Development of guidelines of best practice and inspection check list. torizare_animale_proceduri_53647ro.pdf

9 Difficulties encountered in implementation of Directive 1. Authorisation of the projects;!!!!!!!!!!!!!!any use of animals in scientific purposes must be authorised. 2. Classification of severity of procedures;!!!!!!!!!!!!what means the therm non recovery?????????????? 3. Non-technical project summary.-what kind of data shoud contain?????? 4. Collection and transmission of statistical information in accordance with art. 54 of Directive.- both for MS and COM

10 Challenges for the future 1. Controls in order to verify compliance with the requirements of this Directive, according with art. 34 from Directive.!!!!!!!The controls shall be carried out for at least one third of the users each year in accordance with a risk analysis. Breeders, suppliers and users of non- human primates shall be inspected at least once a year. 2. Audits performed by the Comission, in order to: -assess the effectiveness of implementation; -assess the effectiveness of official controls.

11 1. The Development of national legislation regarding the training of personnel; 2. Starting of the activity of the National Committee-----!!!!!first metting on December 2016; 3. The Development of new guidelines for good practices.

12 CONCLUSIONS 1.Law no. 43/2010 allows the use of animals in procedures only where the purpose of the procedure can not be achieved through other way. 2.Promote the reduce the number of animals in procedures; 3. Ask users a detailed justification for the use of animals and in particular a result of the proceedings if the expected benefits outweigh the harm animals; 4. The obligation of all veterinary authorization of users, breeders and suppliers and all projects; 5. Promote the principles very active 3R, development of alternative methods and increase the quality of research; 6. The staff working with animals should undergo training; 7. The new law provides for the possibility of harmonizing Romanian legislation with that of other MS 8. We believe that the conduct and completion will take about 2-3 years.

13 VA MULTUMESC PENTRU ATENTIE!