S.I. No. 140/2001 - European Communities (Classification, Packaging and Labelling of Pesticides) (Amendment) 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 further effect to Council Directive No. 78/631/EEC of 26 June 1978¹ , hereby make the following Regulations:

1. (1) These Regulations may be cited as the European Communities (Classification, Packaging and Labelling of Pesticides) (Amendment) Regulations, 2001.

(2) The European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1994 and 1999 and these Regulations may be cited together as the European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1994 to 2001 and shall be construed together as one.

(3) These Regulations shall come into operation on the first day of May, 2001.

Interpretation

2. (1) In these Regulations -

“the principal Regulations” means the European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1994 and 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 the Fourth Schedule is a reference to the Fourth Schedule of the Principal Regulations as amended by these Regulations.

(3) A word or expression that is used in any Council Directive 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 concerned.

Amendments

3 Regulations 18 of the Principal Regulations is hereby revoked and is replaced by the following:

“18. (1) Every application for approval of documentation and materials and for clearance of a pesticide shall be subject to the payment of the following fees, that is to say-

(a) for each active substance contained in the pesticide, the fee set out in column (2) of Part 1A of the Fourth Schedule payable to the Minister in respect of the appropriate type of clearance in relation to a category set out in column (1) of the said Part 1A;

(b) in relation to each preparation, the fee set out in column (2) of Part 1B of the Fourth Schedule payable to the Minister in respect of the appropriate type of clearance in relation to a category set out in column (1) of the said Part 1B;

(c) a fee of £150 shall be payable in each case where an application is made for minor amendments to the packaging and labelling or to the documentation and materials submitted in accordance with Regulation 6 (2)(a) or 6 (2)(b), where it is considered that an evaluation of the risks arising for man, animals or the environment is not involved or required.

(d) a fee of £1,000 shall be payable in each case where an application is made for a permission to market in accordance with Regulation 6 (2) (c).

(2) (a) Every grant of a clearance of a pesticide or of a permission to market a pesticide shall be for 12 months from the date of such grant and shall be renewable at the discretion of the Minister for further periods of 12 months on an application being made in that behalf to the Minister and shall be accompanied by the appropriate annual fee set out in Part 2 of the Fourth Schedule and on a request being made to him in that behalf. In the event of a failure to pay the annual fee set out in Part 2 of the Fourth Schedule, within 30 days of the annual fee falling due, renewal of clearance or permission to market, 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 3 of the Fourth Schedule.

(b) Pesticides notified as being on the market on or before the second of December 1985, in accordance with the provisions of the Principal Regulations, may continue to be placed on the market and used if the annual fee set out in Part 2 of the Fourth Schedule has been paid to the Minister, within 30 days of the fee falling due. Where for a particular pesticide, 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 3 of the Fourth Schedule.

(d) In the case of a pesticide already on the market for a period of one 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 in accordance with this paragraph for particular pesticides, where, on the basis of an auditor's certificate furnished to him, he is satisfied that the wholesale sales of the pesticide during the previous calendar year did not exceed -

(i) in the case of pesticides for household, home garden or other amateur use, £5,000, and

(ii) in the case of other pesticides, £15,000.

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

(e) In the case of a pesticide on the market for less than one year prior to the calendar year for which an 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 pesticide during the year for which the annual fee was paid, did not exceed -

(i) in the case of pesticides for household, home garden or other amateur use, £5,000, and

(ii) in the case of other pesticides, £15,000.

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

(3) In the case of a pesticide 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 in accordance with paragraph (1) (a), (b) and (d) shall be reduced by the amount specified in column (2) of Part 1C of the Fourth 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 pesticide 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 1C.

(4) In the case of a pesticide 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 in accordance with paragraph (1) (a), (b) and (d) shall be reduced by the amount specified in column (2) of Part 1D of the Fourth Schedule, on a request being made to the Minister in that behalf, where, on the basis of a market survey report provided by the applicant, he is satisfied that the potential annual wholesale sales of the pesticide do not exceed the amounts specified in column (1) of the said Part 1D. In cases, where the pesticide 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 pesticide during each such year.

(5) Each clearance of a pesticide and each permission to market a pesticide granted and each notification accepted for a pesticide in accordance with the requirements of these Regulations shall be withdrawn if, in each case where such a pesticide continues to be placed on the market, there is a failure to pay the annual renewal fee set out in Part 2 of the Fourth Schedule within 30 days of the fee falling due but an application for a renewal of clearance of a pesticide, or of a permission to market a pesticide or of a notification for a pesticide, as appropriate, may be made more than 30 but not more than 60 days after the renewal fee fell due on payment to the Minister of the late annual renewal fee set out in Part 3 of the Fourth Schedule.

(6) In the case of an application to alter the type of clearance where a clearance has been approved, the fee, or fees, payable in respect of any subsequent clearance shall be reduced by the amount already paid in accordance with paragraph (1) (a) and (b).

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

4 The Fourth Schedule of the Principal Regulations is hereby revoked and is replaced by the following:

“FOURTH SCHEDULE

Regulation 18

PART I

Fees for clearance of pesticides

A. Each active substance contained in the pesticide

Column (1)		Column (2)
		Type of clearance and fee payable
Category	Trial	Limited	Provisional	Restricted or Commercial
	£	£	£	£
I	150	2,000	4,000	4,500

B. Each preparation

Column (1)		Column (2)
		Type of clearance and fee payable
Category	Trial	Limited	Provisional	Restricted or Commercial
	£	£	£	£
1	100	400	1,000	1,500
II	75	200	400	600

In this Schedule -

“Category I”	means a pesticide containing one or more active ingredients of particular specification not previously cleared and for which approval of classification, packaging and labelling in accordance with Regulation 4 of the Principal Regulations, is sought; or means a pesticide for which clearance and approval of classification, packaging and labelling in accordance with Regulation 4 of the Principal Regulations, for a major new area of use or a major formulation change, is sought;
“Category II”	means a pesticide for which clearance and approval of classification, packaging and labelling in accordance with Regulation 4 of the Principal Regulations, for a minor extension in use or a minor formulation changes, is sought;
“Commercial clearance”	means clearance for commercial sale and use of a pesticide;
“Limited clearance”	means clearance for commercial sale and use of a pesticide, in limited quantities or for a limited period or both, subject to specified restrictions or conditions;
“Provisional clearance”	means clearance for commercial sale and use of a pesticide, sometimes for a limited period, subject to specified restrictions or conditions;
“Restricted clearance”	means clearance for commercial sale and use of a pesticide subject to restriction(s) imposed by other statutory provisions or subject to special restrictions;
“Trial clearance”	means clearance for experimental use of a pesticide subject to specified restrictions or conditions.

C. Reduced fees payable for pesticides for specialized use or uses, already on the market for 3 calendar years

	Column (1)	Column (2)
	Wholesale sales in each of three calendar years immediately prior to the year in which the fee is payable	Percentage of the fee payable
		%
	less than £5,000	10
	£5,000 to £9,999	25
	£10,000 to £19,999	50

D. Reduced fees payable for pesticides for specialized use or uses, on the market for less than 3 calendar years

	Column (1)	Column (2)
	Estimated potential annual wholesale sales	Percentage of the fee payable
		%
	less than £10,000	10
	£10,000 to £19,999	25
	£20,000 to £39,999	50

PART 2

	Type of Clearance	Amount
	Annual Fee for a Limited, Provisional, Commercial, or Restricted Clearance, for a Permission to Market and for Notified Pesticides:	£200
	Trial Clearance	£ 50

PART 3

	Type of Clearance	Amount
	Late Annual Renewal Fee for a Limited, Provisional, Commercial, or Restricted Clearance, for a Permission to Market and for Notified Pesticides:	£300
		”

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Given under my Official Seal this 3rd day of April 2001

Joe Walsh

Minister for Agriculture, Food and Rural Development

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 (Classification, Packaging and Labelling of Pesticides) Regulations, 1994 and 1999 ( S.I. No. 138 of 1994 and S.I. No. 463 of 1999 ).

The amendment specifies that annual fees due be provided in a single payment.

¹ O.J. No. L206/13 29/7/1978