European Communities (Authorization, Placing on the Market, Use and Control of Biocidal Products) Regulations, 2001

• Jurisdiction: Ireland

Arrangement of regulations
Regulation 1 Citation and commencement Regulation 2 Interpretation Regulation 3 Application Regulation 4 General provisions concerning applications for authorisation and registration of biocidal products and inclusion of active substances in Annex I, IA or IB Regulation 5 Designation of national authorities Regulation 6 Placing active substances on the market Regulation 7 Applications for the inclusion, or variation of inclusion of active substances in Annex I, IA or IB Regulation 8 Acceptance and evaluation of applications for inclusion, or variation of inclusion of active substances in Annex I, IA or IB Regulation 9 Placing on the market and use of biocidal products Regulation 10 Authorisation, registration and renewal of authorisation and registration of biocidal products Regulation 11 Mutual recognition of authorisations and registrations Regulation 12 Authorisation and registration for provisional periods Regulation 13 Emergency authorisations Regulation 14 Transitional arrangements Regulation 15 Research and development Regulation 16 Authorisation for experimental and test purposes Regulation 17 Trials permits Regulation 18 Cancellation of authorisations and registrations Regulation 19 Modification of authorisations and registrations Regulation 20 Review of authorisations and registrations Regulation 21 Notification of new information Regulation 22 Emergency prohibition or restriction Regulation 23 Frame-formulations Regulation 24 Data protection for information concerning active substances Regulation 25 Data protection for information concerning biocidal products Regulation 26 Confidentiality Regulation 27 Treatment of confidential information Regulation 28 Co-operation in the use of information Regulation 29 Information exchange Regulation 30 Classification packaging and labelling of biocidal products Regulation 31 Samples, drafts and models Regulation 32 Safety data sheets Regulation 33 Advertisements Regulation 34 Poisons control Regulation 35 Files on applications Regulation 36 Notification of imports and exports Regulation 37 Inspections, sampling, tests and examinations Regulation 38 Seizure, retention, removal and disposal Regulation 39 General offences Regulation 40 Prosecutions and specific rules of evidence Regulation 41 Referee analyses Regulation 42 Fees Regulation 43 Civil and criminal liability Regulation 44 Exemptions from certain provisions of the Regulations of 2001
First Schedule Part 1 Annex I List of active substances with requirements agreed at Community level for inclusion in biocidal products Part 2 Annex IA List of active substances with requirements agreed at Community level for inclusion in low-risk biocidal products Part 3 Annex IB List of basic substances with requirements agreed at Community level Part 4 Annex IIA Common core data set for active substances - chemical substances Part 5 Annex IIB Common core data set for biocidal products - chemical products Part 6 Annex IIIA Additional data set for active substances - chemical substances Part 7 Annex IIIB Additional data set for biocidal products - chemical products Part 8 Annex IVA Data set for active substances - fungi, micro-organisms and viruses Part 9 Annex IVB Data set for biocidal products - fungi, micro-organisms and viruses Part 10 Annex V Biocidal product types and their descriptions as referred to in paragraph (1) of Regulation 2 Part 11 Annex VI Common principles for the evaluation of dossiers for biocidal products Second Schedule Part 1 Information and documentation to support a notification for a biocidal product in accordance with paragraph (2) of Regulation 14 Part 2 Notification form for biocidal products Third Schedule Legal instruments relating to products deemed outside the scope of these Regulations pursuant to paragraph (2) of Regulation 3 Fourth Schedule Certificate of result of analysis carried out by a designated analyst Fifth Schedule Certificate of results of analysis carried out by the State Chemist Sixth Schedule Application and annual fees for active substances of biocidal products and for notification, authorisation and registration of biocidal products
S.I. No. 625 of 2001
EUROPEAN COMMUNITIES (AUTHORIZATION, PLACING ON THE MARKET, USE AND CONTROL OF BIOCIDAL PRODUCTS) REGULATIONS, 2001
I, Joe Walsh, Minister for Agriculture, Food and Rural Development, in exercise of the powers conferred on me by Section 3 of the European Communities Act, 1972 (No. 27 of 1972), and for the purpose of giving effect to Directive 98/8/EC of the European Parliament and of the Council of 16 February 19981 hereby make the following Regulations:
	Citation and commencement	1 (1) These Regulations may be cited as the European Communities (Authorisation, Placing on the Market, Use and Control of Biocidal Products) Regulations, 2001.
(2) These Regulations shall come into operation on the first day of January 2002
	Interpretation	2. (1) In these Regulations:
“active substance” means a substance or micro-organism, including a virus or a fungus; having general or specific action on or against harmful organisms;
“Annex I” (which is set out in Part 1 of the First Schedule) means Annex I to the Directive of 1998;
“Annex IA” (which is set out in Part 2 of the First Schedule) means Annex IA to the Directive of 1998;
“Annex IB” (which is set out in Part 3 of the First Schedule) means Annex IB to the Directive of 1998;
“Annex IIA” (which is set out in Part 4 of the First Schedule) means Annex IIA to the Directive of 1998;
“Annex IIB” (which is set out in Part 5 of the First Schedule) means Annex IIB to the Directive of 1998;
“Annex IIIA” (which is set out in Part 6 of the First Schedule) means Annex IIIA to the Directive of 1998;
“Annex IIIB” (which is set out in Part 7 of the First Schedule) means Annex IIIB to the Directive of 1998;
“Annex IVA” (which is set out in Part 8 of the First Schedule) means Annex IVA to the Directive of 1998;
“Annex IVB” (which is set out in Part 9 of the First Schedule) means Annex IVB to the Directive of 1998;
“Annex V” (which is set out in Part 10 of the First Schedule) means Annex V to the Directive of 1998;
“Annex VI” (which is set out in Part 11 of the First Schedule) means Annex VI to the Directive of 1998;
“aircraft” includes hovercraft;
“authorised officer” means an officer of the Minister appointed in writing by the Minister to be an authorised officer for the purposes of these Regulations;
“authorisation” means an administrative act by which the competent authority authorises, following an application submitted by an applicant, the placing on the market of a biocidal product in the State;
“basic substance” means a substance that is listed in Annex IB whose major use is non-pesticidal but which has some minor use as a biocide, either directly or in a product consisting of the substance and a simple diluent which itself is not a substance of concern and which is not directly marketed for the same biocidal use;
“biocidal products” means active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means. An exhaustive list of 23 product types with an indicative set of descriptions of the products within each type is provided in Annex V;
“Commission” means the Commission of the European Union;
“the competent authority” for the purposes of these Regulations is the Pesticide Control Service of the Department of Agriculture, Food and Rural Development;
“controlled product” means any product, food commodity, article or any other thing that is treated, is in the process of being treated, or has been treated with a biocidal product;
“the Directive of 1967” means Council Directive 67/548/EEC of 27 June2 , as last amended by Commission Directive 2001/59/EC3 ;
“the Directive of 1991” means Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market4 ;
“the Directive of 1998” means the Directive of the European Parliament and of the Council No. 98/8/EC of 16 February 1998 on the placing of biocidal products on the market1 ;
“designated analyst” means any appropriately qualified officer of the Minister who is authorised in writing by the Minister for the purposes of these Regulations;
“existing active substance” means an active substance that was on the market in the European Union on or before 14 May 2000 for a biocidal purpose other than for the purpose of process-orientated research and development or scientific research and development;
“experimental biocidal product” means a biocidal product intended for use in tests and experiments for the purposes of scientific research and development or process-oriented research and development, that has not been notified, authorised or registered for the particular use or uses concerned in accordance with these Regulations or an active substance intended exclusively for use in a biocidal product intended for use in tests and experiments for the purposes of scientific research and development or process-oriented research and...