Date: 2020-01-24Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2020/103 of 17 January 2020 amending Implementing Regulation (EU) No 844/2012 as regards the harmonised classification of active substances (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2020/103 amends Implementing Regulation (EU) No 844/2012 regarding the harmonised classification of active substances. This regulation aims to set detailed rules for the submission of proposals to the European Chemicals Agency (the Agency) by the rapporteur Member State during the renewal of active substance approvals. It reallocates time within the renewal procedure and defines timelines for the Agency's risk assessment opinion. It applies to renewal procedures expiring on or after May 13, 2023, unless supplementary dossiers were already submitted before the regulation's adoption date.
Key Points / Main Content:
Renewal Procedure Amendments:
* The deadline for submitting supplementary dossiers is set to no later than 33 months before the expiry of the approval.
* Rapporteur Member States must submit a proposal for classification or reclassification of substances according to Regulation (EC) No 1272/2008.
Harmonised Classification:
* Rapporteur Member States must submit proposals to the Agency for harmonised classification of active substances for specific hazard classes, including explosives, acute toxicity, and environmental hazards.
* Justification is required if harmonised classification is not warranted for certain hazard classes.
* If a classification proposal is already under assessment by the Agency, the rapporteur Member State should limit their proposal to uncovered hazard classes, unless new information is available.
* If the Committee for Risk Assessment has an existing opinion on hazard classes, the rapporteur Member State can justify the opinion's validity.
Timelines and Assessment:
* The period for the rapporteur Member State to prepare the draft renewal assessment report is extended.
* The European Food Safety Authority (the Authority) is given additional time to prepare its conclusion.
* The Committee for Risk Assessment should adopt its opinion within 13 months of the submission date.
* The Authority must examine the draft renewal assessment report within three months of receipt.
* The Authority adopts a conclusion within five months of the Article 12(3) period expiry, or two weeks after the Committee for Risk Assessment's opinion adoption.
Transitional Provisions:
* The regulation does not apply to renewal procedures where supplementary dossiers were submitted before the regulation's adoption.
* The regulation applies to renewal procedures of active substances expiring on or after May 13, 2023.
Impact Analysis:
Rapporteur Member States:
Impact: They are responsible for preparing and submitting proposals for harmonised classification and labelling of active substances to the European Chemicals Agency (ECHA) during the renewal process. This includes providing justifications for not classifying certain hazard classes and ensuring consistency with existing opinions from the Committee for Risk Assessment. They also have adjusted timelines for preparing draft renewal assessment reports.
Action Required: Prepare proposals for classification, justify any non-classification, and adhere to the new timelines for submitting draft renewal assessment reports.
Applicants:
Impact: They have a reduced period to prepare supplementary dossiers for the renewal of active substances.
Action Required: Submit supplementary dossiers no later than 33 months before the expiry of the approval.
European Chemicals Agency (ECHA):
Impact: Receives proposals for harmonised classification from rapporteur Member States and its Committee for Risk Assessment must provide opinions on these classifications within a specified timeframe.
Action Required: Assess proposals for harmonised classification and ensure the Committee for Risk Assessment adopts opinions within 13 months of submission.
European Food Safety Authority (EFSA):
Impact: It has an adjusted timeline for preparing its conclusion on whether the active substance meets approval criteria.
Action Required: Examine the draft renewal assessment report and adopt a conclusion within the revised timelines.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day business.
Regulation EC No 1107/2009: Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market.
Regulation EC No 1272/2008: Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (CLP Regulation).
Commission Implementing Regulation EU No 844/2012: Regulation setting out the provisions necessary for the implementation of the renewal procedure for active substances under Regulation EC No 1107/2009.
European Chemicals Agency (ECHA): An agency of the European Union which implements EU legislation on chemicals.
European Food Safety Authority (EFSA): The European Union agency that provides independent scientific advice and communicates on risks associated with the food chain.
Committee for Risk Assessment: A committee of the European Chemicals Agency (ECHA) that formulates opinions on risks related to chemicals.
24.1.2020 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n U nion L 19/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) 2020/103
of 17 January 2020
amending Implementing Regulation (EU) No 844/2012 as regards the harmonised classification of
active substances
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and
91/414/EEC(1), and in particular Article 19 and Article 78(2) thereof,
Whereas:
(1) Commission Implementing Regulation (EU) No 844/2012(2) sets out the provisions necessary for the
implementation of the renewal procedure for active substances under Regulation (EC) No 1107/2009.
(2) In accordance with Article 36(2) of Regulation (EC) No 1272/2008 of the European Parliament and of the
Council(3), active substances within the meaning of Regulation (EC) No 1107/2009 are normally to be subject to
harmonised classification and labelling. It is therefore appropriate to set detailed rules of procedure regarding the
submission of proposals to the European Chemicals Agency (‘the Agency’) in accordance with Article 37(1) of
Regulation (EC) No 1272/2008 by the rapporteur Member State during the renewal of approval of active
substances pursuant to Article 14 of Regulation (EC) No 1107/2009.
(3) Additional time in the framework of the procedure for renewal should be made available to the rapporteur Member
State for preparing the draft renewal assessment report and the dossier submitted to the Agency, and to the
European Food Safety Authority (‘the Authority’) for preparing its conclusion. The period available to the applicants
between the submission of the application for renewal and the submission of the supplementary dossiers should
therefore be reduced by three months and that period of three months should be reallocated to the periods available
to the rapporteur Member State and the Authority.
(4) It is appropriate that, in general, the rapporteur Member State submits a dossier in accordance with Article 37(1) of
Regulation (EC) No 1272/2008 for at least those hazard classes that are relevant to identify whether an active
substance can be considered as a low-risk active substance according to Article 22 of Regulation (EC)
No 1107/2009 in conjunction with point 5.1.1 of Annex II to that Regulation, which also include the hazard
classes relevant for the cut-off criteria set in points 3.6.2 to 3.6.4 and 3.7 of Annex II to Regulation (EC)
No 1107/2009. The rapporteur Member State should duly justify why no harmonised classification and labelling is
warranted for hazard classes for which it considers that the criteria for harmonised classification and labelling set by
Regulation (EC) No 1272/2008 are not fulfilled.
(1) OJ L 309, 24.11.2009, p. 1.
(2) Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the
implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European
Parliament and the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).
(3) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation
(EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).L 19/2 E N O f f i c i a l J o u r n a l o f t h e E u r o p e an Union 24.1.2020
(5) However, where a proposal has already been submitted to the Agency and its assessment is ongoing, the rapporteur
Member State should limit the proposal to any of those hazard classes that are not covered by the pending proposal,
unless it considers that new information is available that was not part of the pending dossier.
(6) Moreover, for those of the hazard classes listed in point 5.1.1 of Annex II to Regulation (EC) No 1107/2009, which
are already covered by an existing opinion of the Committee for Risk Assessment of the Agency, it is sufficient that
the rapporteur Member State duly justifies that the existing opinion of the Committee for Risk Assessment remains
valid. The Agency may provide its views regarding the rapporteur Member State’s submission.
(7) Indicative timelines should be defined to ensure that the opinion of the Committee for Risk Assessment of the
Agency is available to the Authority prior to the adoption of its conclusion under Article 13 of Regulation (EU)
No 844/2012.
(8) A transitional period should be provided for so that applicants can take account of the reduced period for dossier
preparation between the application for renewal and the submission of the supplementary dossiers. Procedures for
which supplementary dossiers have already been submitted should not be affected.
(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed.
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EU) No 844/2012 is amended as follows:
(1) in Article 6, paragraph 3 is replaced by the following:
‘3. The supplementary dossiers shall be submitted no later than 33 months before the expiry of the approval.’;
(2) in Article 7(1), point (j) is replaced by the following:
‘(j) a proposal for classification where it is considered that the substance has to be classified or reclassified in
accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (*);
_____________
(*) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC
and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1.).’;
(3) Article 11 is amended as follows:
(a) in paragraph 1, ‘12 months’ is replaced by ‘13 months’;
(b) in paragraph 2, point (e) is replaced by the following:
‘(e) a suggestion for the classification, or its confirmation, where applicable, or reclassification of the active
substance in accordance with the criteria of Regulation (EC) No 1272/2008, as specified in and consistent
with the dossier to be submitted pursuant to paragraph 9;’;
(c) in paragraph 5, second sentence, ‘12 months’ is replaced by ‘13 months’;
(d) in paragraph 6, second sentence, ‘12 months’ is replaced by ‘13 months’;
(e) the following paragraph 9 is added:
‘9. The rapporteur Member State shall at the latest at the time of submission of the draft renewal assessment
report submit a proposal to the European Chemicals Agency (‘the Agency’) pursuant to Article 37(1) of
Regulation (EC) No 1272/2008 and in accordance with the Agency’s requirements to obtain an opinion on a
harmonised classification of the active substance at least for the following hazard classes:
— explosives,
— acute toxicity,
— skin corrosion/irritation,
— serious eye damage/eye irritation,24.1.2020 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n U nion L 19/3
— respiratory or skin sensitisation,
— germ cell mutagenicity,
— carcinogenicity,
— reproductive toxicity,
— specific target organ toxicity – single exposure,
— specific target organ toxicity – repeated exposure;
— hazardous to the aquatic environment.
The rapporteur Member State shall duly justify its view that the criteria for classification for one or more of these
hazard classes are not fulfilled.
Where a proposal for classification of an active substance has already been submitted to the Agency and its
assessment is ongoing, the rapporteur Member State shall submit an additional proposal for classification, limited
to any hazard classes listed above that are not covered by the pending proposal unless new information has
become available that was not part of the pending dossier as regards the hazard classes listed above.
For the hazard classes, which are already covered by an existing opinion of the Committee for Risk Assessment of
the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006, whether or not this opinion has
formed the basis of a decision concerning an entry for harmonised classification and labelling of a substance in
Annex VI of Regulation (EC) No 1272/2008, it is sufficient that the rapporteur Member State duly justifies in its
submission to the Agency that the existing opinion, or where it has already formed the basis of a decision
concerning the inclusion in Annex VI, the existing classification remains valid as regards the hazard classes listed
in the first subparagraph. The Agency may provide its views regarding the rapporteur Member State’s submission.’;
(4) the following Article 11b is inserted after Article 11a:
‘Article 11b
The Committee for Risk Assessment shall endeavour to adopt the opinion referred to in Article 37(4) of Regulation
(EC) No 1272/2008 within 13 months from the submission referred to in Article 11(9).’;
(5) in Article 12, paragraph 1 is replaced by the following:
‘1. The Authority shall examine whether the draft renewal assessment report received from the rapporteur Member
State contains all the relevant information in the agreed format and circulate it to the applicant and to the other
Member States at the latest three months after its receipt.’
(6) in Article 13(1), the first sentence is replaced by the following:
‘Within five months from the expiry of the period referred to in Article 12(3), or within two weeks from the adoption
of the opinion of the Committee for Risk Assessment referred to in Article 37(4) of Regulation (EC) No 1272/2008, if
any adopted, whichever occurs later, the Authority shall adopt a conclusion in the light of current scientific and
technical knowledge using guidance documents applicable at the date of the submission of the supplementary dossiers
and in the light of the opinion of the Committee for Risk Assessment on whether the active substance can be expected
to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.’;
(7) in Article 14(1), the second subparagraph is replaced by the following:
‘The renewal report and the draft Regulation shall take into account the draft renewal assessment report of the
rapporteur Member State, the comments referred to in Article 12(3) of this Regulation and the conclusion of the
Authority, where such a conclusion has been submitted, and the opinion of the Committee for Risk Assessment, if
any, referred to in Article 37(4) of Regulation (EC) No 1272/2008.’L 19/4 E N O f f i c i a l J o u r n a l o f t h e E u r o p e an Union 24.1.2020
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
It shall apply to renewal procedures of those active substances for which the approval period expires on or after
13 May 2023.
It shall, however, not apply to renewal procedures of such active substances for which supplementary dossiers have already
been submitted before the date of adoption of this Regulation.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 January 2020.
For the Commission
The President
Ursula VON DER LEYEN