Article 1: Amendments to Regulation (EC) No 1490/2002
Regulation 2002/1490 is amended as follows:
1.
Articles 11 and 12 are replaced by the following:
2.
The Annexes to Regulation 2002/1490 are amended in accordance with Annex I to this Regulation.
Article 2: Amendments to Regulation (EC) No 2229/2004
Regulation 2004/2229 is amended as follows:
1.
Articles 24 and 25 are replaced by the following:
2.
The Annexes to Regulation 2004/2229 are amended in accordance with Annex II to this Regulation.
Article 3: Transitional provisions for Regulation (EC) No 1490/2002
1
As regards active substances for which at the date of entry into force of this Regulation the EFSA had submitted its conclusions to the Commission, Regulation 2002/1490, as it stood before its amendment by this Regulation, shall continue to apply.
2
As regards active substances for which, at the date of entry into force of this Regulation, the draft assessment report by the rapporteur Member State had been sent to the EFSA but for which the EFSA had not submitted its conclusions to the Commission, by way of derogation from Article 11e of Regulation 2002/1490, Article 12(3) of that Regulation shall apply if both of the following conditions are satisfied:
a
Article 11b does not apply and one of the following cases is present:
i
the active substance is not expected to meet the criteria of Annex VI of that Regulation;
ii
upon being consulted by the Commission, the EFSA has concluded that the active substance does not meet the criteria to Annex VI of that Regulation; and
b
the notifier informs the Commission of the withdrawal of his support of the inclusion of the active substance in Annex I to Directive 91/414/EEC within two months from the entry into force of this Regulation.
Article 4: Transitional provisions for Regulation (EC) No 2229/2004
As regards active substances for which, at the date of entry into force of this Regulation, the draft assessment report by the rapporteur Member State had been sent to the EFSA but for which the EFSA had not submitted its conclusions to the Commission, by way of derogation from Article 24e of Regulation 2004/2229, Article 25(3) of that Regulation shall apply if both of the following conditions are satisfied:
a
Article 24b does not apply and one of the following cases is present:
i
the active substance is not expected to meet the criteria of Annex VII of that Regulation;
ii
upon being consulted by the Commission, the EFSA has concluded that the active substance does not meet the criteria to Annex VII of that Regulation; and
b
the notifier informs the Commission of the withdrawal of his support of the inclusion of the active substance in Annex I to Directive 91/414/EEC within two months from the entry into force of this Regulation.
Article 5: This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Union . Official Journal of the European Union
Recital 1
Article 8(2) of Directive 91/414/EEC provides that the Commission undertakes a programme of work for the gradual examination of active substances on the market two years after the date of notification of this Directive. This programme is still ongoing.
Recital 2
The second and third stage of work are laid down by Commission Regulation 2000/451 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC ( 2 ) and Commission Regulation 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC and amending Regulation 2000/451 ( 3 ) . The fourth stage of work is laid down by Commission Regulation 2004/2229 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC ( 4 ) .
Recital 3
Several substances in the third and fourth stages are still in the assessment phase. It appears necessary to speed up the examination process. Depending on whether a substance is already under peer review or not, for certain aspects of the procedure, different provisions should apply.
Recital 4
To speed up the examination process the workflow of the peer review and relationship between notifiers, Member States, the European Food Safety Authority (EFSA) and the Commission and the obligations of each of the parties for the implementation of the programme should be adapted without harming the level of safety for health and the environment.
Recital 5
The resources of the EFSA should be used efficiently. Where there are clear indications that the active substance concerned meets the criteria referred to in Article 5(1) of Directive 91/414/EEC, and in particular does not have any harmful effects on humans or animal health or on groundwater or any unacceptable influence on the environment, that substance should be included in Annex I to that Directive. Such clear cases would not require detailed scientific advice from the EFSA before the substance is included in Annex I. The EFSA should, however, deliver its view on those substances later, in particular to ensure a harmonised approach when Member States apply the uniform principles at the evaluation of authorisations. Where, on the contrary, there are clear indications that an active substance has harmful affects; the Commission is not required to have this clear situation confirmed, so it should have the possibility to decide on non-inclusion without consulting the EFSA.
Recital 6
The EFSA should focus on cases where the remaining doubts need to be resolved before a decision on the inclusion of the active substance concerned can be taken.
Recital 7
To further speed up procedures, it should be possible to grant a longer withdrawal period in cases where there are such remaining doubts and notifiers agree to withdraw their support of the inclusion of the active substance. This procedure should only apply to cases where there are no clear indications that the substance has harmful effects on humans or animal health or on groundwater or any unacceptable influence on the environment.
Recital 8
To identify cases where there are clear indications of either a substance having no harmful effects or, on the contrary, a substance having such effects, criteria should be set out.
Recital 9
In order to ensure that the deadlines for evaluation are met, and to ensure equal treatment of all notifiers, the current legislation provides that notifiers may not submit new studies after a certain stage of the assessment, subject to limited exceptions. This general principle should be retained, but it is appropriate to clarify when notifiers may submit new information other than studies.
Recital 10
Regulations Regulation 2002/1490 and Regulation 2004/2229 should therefore be amended accordingly.
Recital 11
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
Amendments to the Annexes to Regulation 2002/1490
After Annex IV to Regulation (EC) No 1490/2002 the following Annexes are added as Annexes V and VI:
( *2 ) OJ L 396, 30.12.2006, p. 1 ; corrected by OJ L 136, 29.5.2007, p. 3 .
‘ANNEX V
An active substance shall be considered as fulfilling the requirement, as referred to in Article 11b, of there being clear indications that it may be expected that it does not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment if all the criteria set out in points 1 and 2 are met.
The active substance satisfies the following criteria:
An active substance shall be considered as fulfilling the requirement, as referred to in Article 11b, of there being clear indications that it may be expected that it does not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment if all the criteria set out in points 1 and 2 are met.
The active substance satisfies the following criteria:
‘ANNEX VI
An active substance shall be considered as fulfilling the requirement, as referred to in Article 11f, of there being clear indications that on the basis on the available data, and which are evaluated in accordance with the provisions of Article 11d, it may be expected that it has harmful effects on human or animal health or on groundwater if either the criterion in point 1 or one of the criteria in point 2 is met.
As regards the active substance, the existing evidence is not sufficient to allow the establishment of an ADI, ARfD or an AOEL and such values are necessary to conduct a consumer and operator risk assessment.
As regards each supported representative use, at least one of the following criteria is met:
An active substance shall be considered as fulfilling the requirement, as referred to in Article 11f, of there being clear indications that on the basis on the available data, and which are evaluated in accordance with the provisions of Article 11d, it may be expected that it has harmful effects on human or animal health or on groundwater if either the criterion in point 1 or one of the criteria in point 2 is met.
As regards the active substance, the existing evidence is not sufficient to allow the establishment of an ADI, ARfD or an AOEL and such values are necessary to conduct a consumer and operator risk assessment.
As regards each supported representative use, at least one of the following criteria is met:
( *1 ) OJ L 158, 30.4.2004, p. 7 ; corrected by OJ L 229, 29.6.2004, p. 5 .
Amendments to the Annexes to Regulation 2004/2229
After Annex V to Regulation (EC) No 2229/2004 the following Annexes are added as Annexes VI and VII:
( *2 ) OJ L 396, 30.12.2006, p. 1 ; corrected by OJ L 136, 29.5.2007, p. 3 .
‘ANNEX VI
An active substance shall be considered as fulfilling the requirement, as referred to in Article 24b, of there being clear indications that it may be expected that it does not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment if all the criteria set out in points 1 and 2 are met.
The active substance satisfies the following criteria:
An active substance shall be considered as fulfilling the requirement, as referred to in Article 24b, of there being clear indications that it may be expected that it does not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment if all the criteria set out in points 1 and 2 are met.
The active substance satisfies the following criteria:
‘ANNEX VII
An active substance shall be considered as fulfilling the requirement, as referred to in Article 24f, of there being clear indications that on the basis on the available data, and which have been evaluated in accordance with the provisions of Article 24d, it may be expected that it has harmful effects on human or animal health or on groundwater if either the criterion in point 1 or one of the criteria in point 2 is met.
As regards the active substance, the existing evidence is not sufficient to allow the establishment of an ADI, ARfD or an AOEL and such values are necessary to conduct a consumer and operator risk assessment.
As regards each supported representative use, at least one of the following criteria is met:
An active substance shall be considered as fulfilling the requirement, as referred to in Article 24f, of there being clear indications that on the basis on the available data, and which have been evaluated in accordance with the provisions of Article 24d, it may be expected that it has harmful effects on human or animal health or on groundwater if either the criterion in point 1 or one of the criteria in point 2 is met.
As regards the active substance, the existing evidence is not sufficient to allow the establishment of an ADI, ARfD or an AOEL and such values are necessary to conduct a consumer and operator risk assessment.
As regards each supported representative use, at least one of the following criteria is met:
( *1 ) OJ L 158, 30.4.2004, p. 7 ; corrected by OJ L 229, 29.6.2004, p. 5 .
Footnote p0: This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 20 September 2007.