S.I. No. 461/1999 - European Communities (Authorization, Placing on The Market, Use and Control of Plant Protection Products) (Amendment) (No. 4) Regulations, 1999.

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), for the purpose of giving further effect to Council Directive No. 91/414/EEC of 15 July 1991¹ , hereby make the following Regulations:

1. (1) These Regulations may be cited as the European Communities (Authorization, Placing on the Market, Use and Control of Plant Protection Products) (Amendment) (No. 4) Regulations, 1999.

(2) The European Communities (Authorization, Placing on the Market, Use and Control of Plant Protection Products) Regulations, 1994 to 1999 and these Regulations may be cited together as the European Communities (Authorization, Placing on the Market, Use and Control of Plant Protection Products) Regulations, 1994 to 1999 and shall be construed together as one.

(3) These Regulations shall come into operation on the first day of January 2000.

Interpretation.

2. (1) In these Regulations—

“the principal Regulations” means the European Communities (Authorization, Placing on the Market, Use and Control of Plant Protection Products) Regulations, 1994 to 1999;

(2) In these Regulations, unless otherwise indicated—

(a) a reference to a Regulation is a reference to a Regulation of these Regulations,

(b) a reference to a paragraph or subparagraph is a reference to a paragraph or subparagraph of the provision in which the reference occurs,

(c) a reference to a Schedule is a reference to a Schedule of the Principal Regulations as amended by these Regulations.

(3) A word or expression that is used in the Directive of 1991 or in any Commission Directive or Regulation of the European Communities mentioned in these Regulations has, unless the contrary intention appears, the meaning in these Regulations that it has in the Directive or Regulation concerned.

Amendments.

3. Regulation 30 of the Principal Regulations is hereby revoked and is replaced by the following:

“30 (1) Subject to paragraph (8), an authorized officer may at any reasonable time enter—

(a) any place or premises in which he/she has reasonable grounds for believing that—

(i) a plant protection product is being manufactured, placed on the market, stored or used, or

(ii) a controlled product is being produced, placed on the market, processed, stored or used,

(b) any railway wagon, vehicle, ship, vessel, aircraft, container or other thing in which he/she has reasonable grounds for believing that a plant protection product or a controlled product is being either transported, stored or used, or

(c) any premises in which he/she has reasonable grounds for believing that there are any books, documents or records relating to any business whose activities consist of or include—

(i) the manufacture, placing on the market, storage, transport or use of a plant protection product, or

(ii) the production, putting into circulation, processing or storage of any controlled product,

and there or at any other place—

(iii) make such examinations, tests and inspections, and

(iv) take samples in accordance with the methods described in the manual on the development and use of FAO specifications for plant protection products (Food and Agriculture Organization of the United Nations, FAO Plant Production and Protection Paper 128, Fourth Edition), as updated from time to time, of any plant protection product which he/she finds in the course of his/her inspection and which he/she believes is or may be a plant protection product to which these Regulations apply, and

(v) take samples in accordance with Commission Directive 79/700/EEC of 24 July 1979² , or the Joint FAO/WHO Food Standards Progaramme, Codex Alimentarius Commission, recommended method of sampling for the determination of Pesticide Residues (Volume 2, Codex Alimentarius, Food and Agriculture Organisation of the United Nations, World Health Organization, Rome, 1993), where relevant, and in accordance with other internationally accepted procedures in other cases, of any plant, plant product, soil, compost, or take samples from or of any other thing, which he/she finds in the course of an inspection and which he/she believes may have been treated or contaminated with a plant protection product to which the Regulations apply,

as he/she may consider appropriate and provided the quantity which a sample taken pursuant to this Regulation comprises is reasonable.

(2) A person who has in any place, on any premises or in any railway wagon, vehicle, ship, vessel, aircraft, container or other thing a plant protection product to which these Regulations apply, or a controlled product, shall at all reasonable times—

(a) afford to an authorised officer such facilities and assistance as are reasonably necessary for an inspection and for the taking of samples pursuant to this Regulation,

(b) give an authorised officer any information which he/she may reasonably require regarding the purchase, importation, storage, transportation, sale, supply or use of any such plant protection product or regarding the production, purchase, importation, processing, transport, storage, sale, supply or use of any controlled product, which is within the person's knowledge or procurement,

(c) produce to an authorised officer any document relating to the raw materials used in the formulation of any plant protection product or relating to the production of any controlled product which the authorised officer may reasonably require and when produced permit the officer to inspect and take extracts from the document.

(3) In addition to the foregoing any person who carries on the business of manufacturing, formulating, packaging, processing or marketing a plant protection product for the purposes of the Directive of 1991 shall—

(a) keep records of all transactions regarding the plant protection product,

(b) produce at the request of an authorised officer any records, books or other documents relating to such business which are in his/her possession or under his/her control,

(c) permit such an officer to inspect and take extracts from such records, books or other documents and give to the officer any information which is within his/her knowledge or under his/her control and which such officer may reasonably require in relation to any entries therein,

(d) afford to any such an officer such facilities and assistance as are reasonably necessary for inspecting the stock of any plant protection product on any premises on which such person carries on such a business,

(e) give to such an officer any information he/she may reasonably require in relation to such transactions, including, in particular, information which he/she may reasonably require regarding any plant protection product specified by him/her.

(4) Where a sample is taken pursuant to this Regulation, the authorised officer concerned shall—

(a) divide the sample into 3 or more parts, each of which he/she shall seal and mark,

(b) give one part thereof to a designated analyst for analysis in accordance with paragraph (5),

(c) leave with, deliver to, or send by registered post to, the defendant or his/her agent, a second part thereof,

(d) where there is more than one defendant, leave with, deliver to, or send by registered post to such defendant, a further part thereof, and

(e) give the remaining part thereof to the State Chemist for analysis in accordance with Regulation 34.

(5) Where a designated analyst or the State Chemist receives a sample from an authorized officer taken in pursuance of these Regulations, he/she shall make analyses thereof using validated analytical methods.

(6) (a) in any proceedings for an offence under these Regulations, the result of any test, examination or analysis of, or any report on, a sample taken pursuant to this Regulation shall not be adduced unless before the proceedings were instituted, one of the parts into which the sample was divided (as required by paragraph (4)) was left with, delivered to, or sent by registered post to, the defendant or his/her agent.

(b) In any proceedings for an offence under these Regulations, evidence of the presence of a plant protection product to which the Regulations apply, in or on equipment capable of use for application of the pesticide, shall be evidence, until the contrary is proved, of the use of the plant protection product by the owner or person in possession of the equipment.

(c) In any proceedings for an offence under these Regulations, evidence of the presence of a residue of a plant protection product to which the Regulations apply, in or on agricultural produce, in soil or compost or in or on surfaces or other materials which may have been treated with or exposed to the plant protection product, shall be evidence, until the contrary is proved, of the use of the plant protection product by the owner, occupier or person in possession, as the case may be.

(d) In any proceedings for an offence under these Regulations, a certificate in the form set out in Part 1 of the Twelfth Schedule showing the results of an analysis shall, until the contrary is shown, be sufficient evidence of the facts certified to therein in relation to—

(i) the presence in a plant protection product of any active substance, impurity or formulating ingredient, and the level of any such presence, or

(ii) the presence of a residue of a plant protection product and the level of such residues in any controlled product, and

a document purporting to be such a certificate shall be deemed, until the contrary is shown, to be such a certificate.

(e) In any proceedings for an offence under these Regulations, each of the documents referred to in subparagraphs (1) (c) (iv) and (v) may be proved by the production of a copy thereof purporting to have been published in the Official Journal of European Communities, by the Food and Agriculture Organization of the United Nations, as appropriate.

(f) For the purpose of these Regulations, the presence of a plant protection product, to which these Regulations apply, on any premises (including any stores), shall, until the contrary is shown, be sufficient evidence that the plant protection product in question is or was being placed on the market or used by the owner and by the occupier of such premises.

(7) If any person—

(a) tampers with any plant protection product so as to procure that any sample of it taken pursuant to these Regulations does not correctly represent the plant protection product,

(b) tampers with any controlled product so as to procure that any sample of it taken pursuant to these Regulations does not correctly represent the product sampled, or

(c) tampers or interferes with any sample taken pursuant to these Regulations,

he/she shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000 or to imprisonment for a term not exceeding 6 months or to both.

(8) An authorised officer shall be furnished with a certificate of his/her appointment as an authorised officer and when exercising any power conferred on him/her by these Regulations shall, if requested by any person affected, produce the certificate to that person.

(9) A designated analyst shall be furnished with a warrant of his/her appointment by the Minister to carry out analyses as required by these Regulations.”

4. Regulation 33 of the Principal Regulations is hereby revoked and is replaced by the following:

“33 (1) An offence under these Regulations may be prosecuted by the Minister.

(2) In proceedings for an offence under Regulation 32 (1), evidence that claims have been made that a product—

(a) protects plants or plant products against harmful organisms or prevents the action of such organisms.

(b) influences the life processes of plants, other than as a nutrient, (e.g. growth regulators),

(c) preserves plant products,

(d) destroys undesired plants, or

(e) destroys parts of plants, checks or prevents undesired growth of plants,

shall, until the contrary is shown, be sufficient evidence that it is a plant protection product to which these Regulations apply.”

5. Regulation 36 and Regulation 37 of the Principal Regulations are hereby revoked and are replaced by the following:

“36 (1) The consideration of every application for the authorization of a plant protection product, for the renewal or modification or an authorization granted, for an extension in the field of use of an authorized plant protection product, for the renewal of an extension granted, for the authorization of a plant protection product for trials purposes, for the renewal or variation in the conditions or restrictions of such an authorization, for a trials permit, for the renewal or variation in the conditions or restrictions of a trials permit, for the inclusion of an active substance in Annex I, or for the modification of the conditions or restrictions associated with any-such inclusion, shall be subject to the payment of the following fees at the times specified, that is to say—

(a) in the case of an application for authorization of a plant protection product in accordance with Regulation 13, 15, or 18, the fee, or fees as appropriate, set out in column (2) of Part 1 of the Thirteenth Schedule, payable to the Minister in respect of the evaluation of the dossiers set out in column (1) of the said Part 1;

(b) in the case of an application for—

(i) inclusion of an active substance in Annex I in accordance with Articles 5 and 6 or 8.2 of the Directive,

(ii) the renewal of the inclusion of an active substance in Annex I in accordance with Article 5 of the Directive, or

(iii) a modification of the conditions or restrictions associated with any such inclusion,

the fee, or fees as appropriate, set out in column (2) of Part 2 of the Thirteenth Schedule, payable to the Minister in respect of the evaluation of the dossiers set out in column (1) of the said Part 2;

(c) in the case of an application for the renewal of an authorization in accordance with Regulation 19 (1), the fee, or fees as appropriate, set out in column (2) of Part 1 of the Thirteenth Schedule, payable to the Minister in respect of the evaluation of the dossiers set out in column (1) of the said Part 1;

(d) in the case of an application for the modification of an authorization in accordance with Regulation 19 (4), the fee, or fees as appropriate, set out in column (2) of Part 3 of the Thirteenth Schedule, payable to the Minister in respect of the each such modification in relation to a category set out in column (1) of the said Part 3;

(e) a fee of £150 shall be payable to the Minister in each case where an application is made for a minor amendment to the packaging and labelling or to the documentation, information and materials submitted in accordance with Regulation 8 (3), where it is considered that an evaluation of the risks arising for man, animals or the environment or an evaluation of the performance of the plant protection product are not involved or required;

(f) a fee of £1,000 shall be payable to the Minister in each case where an application is made for a permission to market in accordance with Regulation 5 (3); and

(g) a fee of £200 shall be payable to the Minister in each case where an application is made for an extension in field of use of an authorized plant protection product, in accordance with Regulation 16.

(2) (a) The consideration of every application for the authorization of a plant protection product for trials purposes in accordance with the provisions of Regulation 25 shall be subject to the payment of a fee of £250 payable to the Minister.

(b) The renewal of an authorization of a plant protection product for trials purposes in accordance with the provisions of Regulation 25 shall be subject to the payment of a fee of £50 payable to the Minister.

(c) The variation of the conditions or restrictions of an authorization of a plant protection product for trials purposes in accordance with the provisions of Regulation 25 shall be subject to the payment of a fee of £50 payable to the Minister.

(3) (a) The consideration of every application for a trials permit in accordance with the provisions of Regulation 26 shall be subject to the payment of a fee of £1,000 payable to the Minister.

(b) The renewal of a trials permit in accordance with the provisions of Regulation 26 shall be subject to the payment of a fee of £250 payable to the Minister.

(c) The variation in conditions or restrictions of a trials permit in accordance with the provisions of Regulation 26 shall be subject to the payment of a fee of £250 payable to the Minister.

(4) (a) Authorization, whether or not, for a provisional period, or permission to market for a plant protection product, granted in accordance with the requirements of these Regulations or clearance before 1 October 1994 in accordance with the provisions of the Regulations of 1994 shall be revoked if there is a failure to pay the annual fee set out in Part 4 of the Thirteenth Schedule, within 30 days of the annual fee falling due, but renewal of authorization or permission to market or clearance, as appropriate, may be granted where application is made more than 30 days but not more than 60 days after the annual fee fell due, on payment to the Minister of the late annual fee set out in Part 4 of the Thirteenth Schedule.

(b) Plant protection products notified as being on the market on or before the second of December 1985 in accordance with the provisions of the Regulations of 1994, may continue to be placed on the market and used if the annual fee set out in Part 4 of the Thirteenth Schedule has been paid to the Minister, within 30 days of the annual fee falling due. Where for a particular plant protection product, the annual fee has not been paid by the date due, the notification concerned shall be revoked, but renewal of the notification may be granted where application is made more than 30 days but not more than 60 days after the annual fee fell due, on payment to the Minister of the late annual fee set out in Part 4 of the Thirteenth Schedule.

(c) Notwithstanding the periods for which authorization or permissions are granted are valid, one half of the annual fees payable in accordance with subparagraph (a) shall be paid by 1 April of each year, the balance by 1 September of each year. One half of the annual fees payable in accordance with subparagraph (b) shall be paid by 1 April of each year, the balance by 1 September of each year.

(d) In the case of a plant protection product already on the market for a period of a year or more prior to the calendar year for which the annual fee is payable, the Minister may reduce the level of the annual fee payable to the Minister under this paragraph for particular plant protection products, where, on the basis of an auditor's certificate furnished to him, he is satisfied that the wholesale sales of the plant protection product during the previous calendar year did not exceed—

(i) in the case of plant protection products for household or home garden use, £5,000, and

(ii) in the case of other plant protection products, £15,000.

In all such cases, the minimum fee payable for each such plant protection product shall be £50.

(e) In the case of a plant protection product on the market for less than one year prior to the calendar year for which the annual fee is payable, the Minister may refund part of the annual fee payable in accordance with this paragraph, on a request being made to him in that behalf, where, on the basis of an auditor's certificate furnished to him, he is satisfied that the wholesale sales of the plant protection product during the year for which the annual fee was paid, did not exceed—

(i) in the case of plant protection products for household or home garden use, £5,000, and

(ii) in the case of other plant protection products, £15,000.

In all such cases, any refund made shall be such that for each such plant protection product, the minimum fee payable shall be £50.

(5) In the case of a plant protection product already on the market for a period of three years or more prior to the calendar year in which the fee is payable and which is placed on the market exclusively for a specialized use or specialized uses, the fee or fees payable under subparagraphs (1) (a), (c), (d) and (f) shall be reduced by the amount specified in column (2) of Part 5A of the Thirteenth Schedule, on a request being made to the Minister in that behalf, where, on the basis of an auditor's certificate furnished to him, he is satisfied that the wholesale sales of the plant protection product during each of the three calendar years immediately prior to the year in which the fee or fees are payable, did not exceed the amounts specified in column (1) of the said part 5A.

(6) In the case of a plant protection product on the market for a period of less than three years prior to the calendar year in which the fee is payable and which is placed on the market exclusively for a specialized use or specialized uses, the fee or fees payable under subparagraph (1) (a), (c), (d) and (f) shall be reduced by the amount specified in column (2) of Part 5B of the Thirteenth Schedule, on a request being made to the Minister in that behalf, where, on the basis of a market survey report provided to him by the applicant, he is satisfied that the potential annual wholesale sales of the plant protection product are unlikely to exceed the amounts specified in column (1) of the said part 5B. In cases, where the plant protection product has been on the market for one or two years immediately prior to the calendar year in which the fee is payable, any application made for a reduction in fees must be supported by an auditor's certificate relating to the wholesale sales of the plant protection product during each such year.

(7) In the case of an active substance, which because of its nature and proposed uses, can be evaluated on the basis of a reduced data base, the fee payable in accordance with subparagraph (1) (b) may be reduced by the Minister on a request being made to him in that behalf.

(8) In the case of an application for the authorization of a plant protection product for trials purposes, the fee payable under paragraph (2) may be reduced by the Minister on a request being made to him in that behalf where the potential area of use is limited to a specialised area or specialised areas of use.

(9) A fee payable under these Regulations may be recovered by the Minister as a simple contract debt in any court of competent jurisdiction.

37    A person who makes a claim for a reduction or a refund of fees in accordance with paragraphs Regulation 36 (4), (5), (6) or (7) shall, at all reasonable times—

(a) produce, at the request of an authorised officer, any records, books or other documents which are in his/her possession or under his/her control which substantiate such a claim,

(b) permit the authorized officer to inspect and take extracts from such records, books or other documents and give to the authorized officer any information which is within his/her knowledge or under his/her control and which such officer may reasonably require for the purpose of verifying the claim.

(c) afford to such an officer such facilities and assistance as are reasonably necessary for inspecting the stock of the relevant plant protection product if the authorized officer considers such inspection is necessary for the purpose of verifying the claim.”

6. The Thirteenth Schedule as set out in the Principal Regulations is hereby revoked and replaced by the following:

“THIRTEENTH SCHEDULE

PART 1

Regulations 36 (1) (a) and (c)

Fees for the consideration of applications for the authorization of plant protection products in accordance with Regulations 13, 15 and 18, and for their renewal in accordance with Regulation 19 (1)

PART 2

Regulation 36 (1) (b)

Fees for the consideration of applications for the inclusion of an active substance in Annex I of the Directive, for the renewal of any such inclusion and for the modification of any conditions or restrictions associated with the inclusion of an active substance in Annex I

PART 3

Regulation 36 (1) (d)

Fees for the consideration of applications for modification of authorization for plant protection products in accordance with Regulation 19 (4)

“Category I”    means a modification in the authorization of a plant protection product involving a major additional use, a major change in the manner of use, or a major formulation change;

“Category II”   means a modification in the authorization of a plant protection product involving a minor additional use, a minor change in the manner of use, or a minor formulation change;

PART 4

Regulation 36 (4) (a), (b) and (f)

PART 5

Regulation 36 (5) and (6)

A. Reduced fees payable for plant protection products for specialized use or uses, already on the market for 3 calendar years

B. Reduced fees payable for plant protection products for specialized use or uses, on the market for less than 3 calendar years

EXPLANATORY NOTE.

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations amend the European Communities (Authorization, Placing on the Market, Use and Control of Plant Production Products) Regulations, 1994 to 1999 ( S.I. No. 139 of 1994 , S.I. No. 200 of 1995 , S.I. No. 159 of 1996 , S.I. No. 290 of 1997 , S.I. No. 466 of 1997 , S.I. No. 182 of 1999 , S.I. No. 198 of 1999 and S.I. No. 356 of 1999 ).

The amendments specify revision to the monitoring and control arrangements under the Regulations and to fees for applications for the authorisation of plant protection products. The Regulations also provide for evidence for prosecution under the Regulations and for the application of an annual fee.

¹ O.J. No. L230/1 19/8/1991

² O.J. No. L207/26, 15/8/1979