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

JurisdictionIreland
CitationIR SI 625/2001
Year2001

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...

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