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.
No	Common name, identification numbers	IUPAC name	Purity^a	Entry into force	Expiration of inclusion	Specific provisions
‘326	Dodine CAS No: 2439-10-3 CIPAC No: 101	1-dodecylguanidinium acetate	≥ 950 g/kg	1 June 2011	31 May 2021	PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on dodine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the potential long-term risk to birds and mammals; (b) the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures; (c) the risk to non-target plants in the off-field area and ensure that conditions of use impose adequate risk mitigation measures; (d) the monitoring of residue levels in pome fruit. The Member States concerned shall request the submission of confirmatory information as regards: (a) long-term risk assessment for birds and mammals; (b) risk assessment in natural surface water systems where major metabolites have potentially formed. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.’

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

Common name, identification numbers

IUPAC name

Purity^a

Entry into force

Expiration of inclusion

Specific provisions

‘326

Dodine

CAS No: 2439-10-3

CIPAC No: 101

1-dodecylguanidinium acetate

≥ 950 g/kg

1 June 2011

31 May 2021

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on dodine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.

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

(a)

the potential long-term risk to birds and mammals;

(b)

the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures;

(c)

the risk to non-target plants in the off-field area and ensure that conditions of use impose adequate risk mitigation measures;

(d)

the monitoring of residue levels in pome fruit.

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

(a)

long-term risk assessment for birds and mammals;

(b)

risk assessment in natural surface water systems where major metabolites have potentially formed.

The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.’