CHAPTER IIIPLANT PROTECTION PRODUCTS
SECTION 1Authorisation
Article 43Renewal of authorisation
1.
An authorisation shall be renewed upon application by the authorisation holder, provided that the requirements referred to in Article 29 are still met.
2.
Within 3 months from the renewal of the approval F1in relation to a constituent territory of an active substance, safener or synergist contained in the plant protection product F2authorised in that constituent territory, the applicant shall submit the following information F3to the competent authority for that constituent territory:
(a)
a copy of the authorisation of the plant protection product;
(b)
any new information required as a result of amendments in data requirements or criteria;
(c)
evidence that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of approval;
(d)
any information required to demonstrate that the plant protection product meets the requirements set F4by the competent authority on the renewal of the approval of the active substance, safener or synergist contained therein;
(e)
a report on the monitoring information, where the authorisation was subject to monitoring.
3.
F5(a)
F8(b)
The competent authority which examined the plant protection product application in accordance with Article 35(2) may coordinate the compliance check and assessment of the information submitted for all competent authorities which receive an application for renewal of authorisation for the same product, provided that the conditions in Article 35(2) apply in relation to the renewal application.
F94.
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5.
F10The competent authority examining the application shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the renewal of the approval of the active substance, safener or synergist contained therein.
6.
Where, for reasons beyond the control of the holder of the authorisation, no decision is taken on the renewal of the authorisation before its expiry, the F11competent authority examining the application shall extend the authorisation for the period necessary to complete the examination and adopt a decision on the renewal.
Article 44Withdrawal or amendment of an authorisation
1.
F12A competent authority may review an authorisation at any time where there are indications that a requirement referred to in Article 29 is no longer satisfied.
A F13competent authority shall review an authorisation where it concludes that the F14environmental objectives of a river basin district may not be achieved.
2.
Where a F15competent authority intends to withdraw or amend an authorisation, it shall inform the authorisation holder and give him the possibility to submit comments or further information.
3.
The F16competent authority shall withdraw or amend the authorisation, as appropriate, where:
(a)
the requirements referred to in Article 29 are not or are no longer satisfied;
(b)
false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted;
(c)
a condition included in the authorisation has not been met;
(d)
on the basis of developments in scientific and technical knowledge, the manner of use and amounts used can be modified; or
(e)
the authorisation holder fails to comply with the obligations resulting from this Regulation.
4.
Where a F17competent authority withdraws or amends an authorisation in accordance with paragraph 3, it shall immediately inform the holder of the authorisation F18and the other competent authorities. The other F19competent authorities may withdraw or amend the authorisation accordingly taking into account F20conditions in its constituent territory and risk mitigation measures except for cases where the second F21or third subparagraphs of Article 36(3) have been applied. Article 46 shall apply where appropriate.
F22(5.
In paragraph 1, “environmental objectives”—
(a)
in relation to the Northumbria River Basin District, means the objectives referred to in the WFD Regulations as applied by regulation 5 of the Water Environment (Water Framework Directive) (Northumbria River Basin District) Regulations 2003;
(b)
in relation to the Solway Tweed River Basin District, means the objectives as defined in regulation 2 of the Water Environment (Water Framework Directive) (Solway Tweed River Basin District) Regulations 2004;
(c)
in relation to any other river basin district, within the meaning of the WFD Regulations, has the same meaning as in those regulations;
(d)
in relation to a river basin district in Scotland, means the objectives set under section 9(1)(a)(i) of the Water Environment and Water Services (Scotland) Act 2003.
(6.
In paragraph 4, the “conditions” in the constituent territory of a competent authority include—
(a)
any data requirements specified in regulations made under Article 8(4)(a) or (b) in relation to that constituent territory;
(b)
any uniform principles prescribed by regulations made under Article 29(6)(a) in relation to that constituent territory;
(c)
any guidance issued under Article 77 in relation to that constituent territory.
(7.
In this Article—
(a)
“river basin district” means any of the following—
i)
the Northumbria River Basin District;
ii)
the Solway Tweed River Basin District;
iii)
a river basin district within the meaning of the WFD Regulations;
iv)
in relation to Scotland, an area designated as a river basin district by order under section 4(1) of the Water Environment and Water Services (Scotland) Act 2003;
(b)
“the WFD Regulations” means the Water Environment (Water Framework Directive) (England and Wales) Regulations 2017.
Article 45Withdrawal or amendment of an authorisation at the request of the authorisation holder
1.
An authorisation may be withdrawn or amended at the request of the holder of the authorisation, who shall state the reasons for his request.
2.
Amendments may only be granted where it is established that the requirements referred to in Article 29 continue to be met.
3.
Article 46 shall apply where appropriate.
Article 46Grace period
Where a F23competent authority withdraws or amends an authorisation or does not renew it, it may grant a grace period for the disposal, storage, placing on the market and use of existing stocks.
Where the reasons for withdrawal, amendment or non-renewal of the authorisation are not related to the protection of human and animal health or the environment, the grace period shall be limited and shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned.