Europaudvalget 2023-24
KOM (2022) 0305
Offentligt
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Article 43 bis
Amendments to Regulation (EC) No 1107/2009 of European Parliament and the Council of 21
October 2009 concerning the placing of plant proception products on the market and repealing
Council Directives 79/117/EEC and 91/414/EEC
Regulation (EC) 1107/2009 is proposed amended as follows:
1) After Article 11(1), the following subparagraph is proposed to be added:
“Within 3 months of the date of the notification provided for in the first subparagraph
of
Article 9(3), the rapporteur Member State shall make an assessment according to Article 4 on
whether the active substance complies with the criteria provided for in article 4 and point 5 of
Annex II as a biocontrol low-risk active substance. If these criteria are met, the rapporteur
Member State has an additional 6 months to complete the assessment in accordance to
Articles
4 and 22 and perform the tasks set out in the first subparagraph of Article 11(1).”
Provided that Article 11(1) is amended as proposed, the period in Article 11(3) shall also be
adjusted to 9 months by which the rapporteur Member State needs additional studies or
information to make an assessment.
2) After Article 13(1), the following subparagraph is proposed to be added:
“For a biocontrol low-risk
active substance as referred to in Article 22(1), the Commission shall
perform the tasks set out in the first subparagraph of Article 13(1) within three months of
receiving the conclusion from the Authority.”
3) After Article 22(1), the following subparagraph is proposed added:
“A low-risk
active substance, that complies with the criteria set out in point 5.3 of Annex II
regarding biocontrol active substances, shall be approved for a period not exceeding
20 years,
provided
that the other approval criteria in Article 22(1) and (2) are satisfied.”
Alternatively
 kom (2022) 0305 - Endeligt svar på spørgsmål 2: Spm. om oversendelse af det danske forslag til at fremme mikrobiologiske plantebeskyttelsesmidler
“A low-risk
active substance, that complies with the criteria set out in point 5.3 of Annex II
regarding biocontrol active substances, shall be approved for an
unlimited
period of time,
provided that the other approval criteria in Article 22(1) and (2) are satisfied.”
Provided that Article 22(1) is amended as proposed and biocontrol low-risk active substances
are approved for an unlimited period of time, point 15 and/or point 17 in the preamble may be
adjusted accordingly. Moreover, it should be clear from the list of approved active substances
in accordance with the Regulation referred to in Article 13(4) and 22(2), which biocontrol low-
risk active substances are approved for an unlimited period. Furthermore, it is proposed that it
is explicitly defined that the Commission shall be empowered to include, restrict or remove a
biocontrol low-risk active substance from the list of approved active substances in accordance
with the Regulation referred to in Article 13(4) and 22(2).
4) Transitional measures
Provided that the proposed amendments are adopted, some transitional measures should be
considered, which establish that the new provisions are applicable only to new approvals or
renewal of approvals of biocontrol low-risk substances, which are included on the list of
approved active substances in accordance with the Regulation referred to in Article 13(4) and
22(2), and not to the submitted applications that are under assessment at the time of entry
into force of the proposed amendments.
5) In Annex II, the following subparagraph is proposed added:
”5.3. Biocontrol active substances
Biocontrol active substances means active substances of biological origin or substances
identical to them, such as micro-organisms, semiochemicals, extracts from plant products as
defined in Article 3(6) of Regulation (EC) No 1107/2009, or invertebrate macro-organisms.”