ANNEX

The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

^a Further details on identity and specification of active substance are provided in the review report.
^b (4S,5S)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4R,5R)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one.
No	Common name, identification numbers	IUPAC name	Purity^a	Entry into force	Expiration of inclusion	Specific provisions
‘343	Hexythiazox CAS No 78587-05-0 CIPAC No 439	(4RS,5RS)-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxo-1,3-thiazolidine-3-carboxamide	≥ 976 g/kg (1:1 mixture of (4R, 5R) and (4S, 5S))	1 June 2011	31 May 2021	PART A Only uses as acaricide may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on hexythiazox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate, the operators and workers safety. Conditions of use shall include protective measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards: (a) the toxicological relevance of the metabolite PT-1-3^b; (b) the potential occurrence of the metabolite PT-1-3 in processed commodities; (c) the potential adverse effects of hexythiazox on bee brood; (d) the possible impact of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 31 May 2013 and the information set out in point (d) 2 years after the adoption of specific guidance.’

Further details on identity and specification of active substance are provided in the review report.

(4S,5S)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4R,5R)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one.

Common name, identification numbers

IUPAC name

Purity^a

Entry into force

Expiration of inclusion

Specific provisions

‘343

Hexythiazox

CAS No 78587-05-0

CIPAC No 439

(4RS,5RS)-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxo-1,3-thiazolidine-3-carboxamide

≥ 976 g/kg

(1:1 mixture of (4R, 5R) and (4S, 5S))

1 June 2011

31 May 2021

PART A

Only uses as acaricide may be authorised.

PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on hexythiazox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate,
the operators and workers safety. Conditions of use shall include protective measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

(a)

the toxicological relevance of the metabolite PT-1-3^b;

(b)

the potential occurrence of the metabolite PT-1-3 in processed commodities;

(c)

the potential adverse effects of hexythiazox on bee brood;

(d)

the possible impact of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 31 May 2013 and the information set out in point (d) 2 years after the adoption of specific guidance.’