CHAPTER IIACTIVE SUBSTANCES, SAFENERS, SYNERGISTS AND CO-FORMULANTS
SECTION 1Active substances
Subsection 4Derogations
Article 23Approval criteria for basic substances
1
Basic substances shall be approved in accordance with F7this Article. F1...
For the purpose of F7this Article, a basic substance is an active substance which:
a
is not a substance of concern; and
b
does not have an inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects; and
c
is not predominantly used for plant protection purposes but nevertheless is useful in plant protection either directly or in a product consisting of the substance and a simple diluent; and
d
is not placed on the market as a plant protection product.
For the purpose of this Regulation, an active substance which fulfils the criteria of a ‘foodstuff’ as defined in Article 2 of Regulation (EC) No 178/2002 shall be considered as a basic substance.
2
By way of derogation from Article 4, a basic substance shall be approved where any relevant evaluations, carried out in accordance with other F2... legislation regulating the use of that substance for purposes other than for a plant protection product, show that the substance has neither an immediate or delayed harmful effect on human or animal health nor an unacceptable effect on the environment.
3
By way of derogation from Article 7 an application for the approval of a basic substance shall be submitted F3... by any interested party to the F8the competent authority for the constituent territory in relation to which approval is sought.
The application shall be accompanied by the following information:
a
any evaluations of its possible effects on human or animal health or the environment carried out in accordance with other F9... legislation regulating the use of the substance; and
b
other relevant information on its possible effects on human or animal health or the environment.
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Article 6 applies to the approval of a basic substance.
5A
Within the decision period following receipt of the application and accompanying information, the competent authority must decide to either—
a
approve the basic substance, subject to conditions or restrictions, as referred to in Article 6(1), where appropriate, or
b
refuse to approve the basic substance.
5B
In paragraph 5A, the “decision period” is—
a
where the competent authority obtains independent scientific advice in respect of the application, nine months;
b
otherwise, six months.
5C
In making a decision under paragraph 5A, the competent authority must have regard to—
a
the application and accompanying information,
b
where the competent authority considers it appropriate to obtain it, any independent scientific advice obtained,
c
where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council are relevant, the precautionary principle, and
d
any other matters which the competent authority considers relevant to the competent authority's determination of the application.
5D
As soon as reasonably practicable after making a decision under paragraph 5A, the competent authority must—
a
notify the applicant and the other competent authorities in writing of that decision and the reasons for it, and
b
update the approvals register accordingly.
5E
Article 20A applies to an approval of a basic substance which is subject to a condition in accordance with Article 6(1)(f) as it applies to an approval of an active substance.
5F
The Secretary of State may make a decision under paragraph 5A instead of a competent authority—
a
in relation to Wales, with the consent of the Welsh Ministers;
b
in relation to Scotland, with the consent of the Scottish Ministers.
5G
Where the Secretary of State makes a decision in accordance with paragraph 5F, a reference in paragraphs 5A to 5D to the competent authority is to be read as a reference to the Secretary of State.
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