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Commission Directive (EU) 2019/782 of 15 May 2019 amending Directive 2009/128/EC of the European Parliament and of the Council as regards the establishment of harmonised risk indicators (Text with EEA relevance)
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The harmonised risk indicators are listed in Sections 2 and 3 of this Annex.
the Harmonised Risk Indicator 1 shall be calculated on the basis of the categorisation of active substances into the 4 Groups and 7 Categories set out in Table 1;
the active substances in Group 1 (categories A and B) shall be those listed in Part D of the Annex to Commission Implementing Regulation (EU) No 540/2011(1);
the active substances in Group 2 (categories C and D) shall be those listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011;
the active substances in Group 3 (categories E and F) shall be those listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011;
the active substances in Group 4 (category G) shall be those not approved under Regulation (EC) No 1107/2009, and therefore not listed in the Annex to Implementing Regulation (EU) No 540/2011;
the weightings in row (vi) in Table 1 shall apply.
Categorisation of active substances and hazard weightings for the purpose of calculating Harmonised Risk Indicator 1
Row | Groups | ||||||
---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | ||||
(i) | Low-risk active substances which are approved or deemed to be approved under Article 22 of Regulation (EC) No 1107/2009, and which are listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011 | Active substances approved or deemed to be approved under Regulation (EC) No 1107/2009, and not falling in other categories, and which are listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011 | Active substances approved or deemed to be approved under Article 24 of Regulation (EC) No 1107/2009, which are candidates for substitution, and which are listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011 | Active substances which are not approved under Regulation (EC) No 1107/2009, and therefore which are not listed in the Annex to Implementing Regulation (EU) No 540/2011 | |||
(ii) | Categories | ||||||
(iii) | A | B | C | D | E | F | G |
(iv) | Micro-organisms | Chemical active substances | Micro-organisms | Chemical active substances | Which are not classified as: Carcinogenic Category 1A or 1B and/or Toxic for Reproduction Category 1A or 1B and/or Endocrine disruptors | Which are classified as: Carcinogenic Category 1A or 1B and/or Toxic for Reproduction Category 1A or 1B and/or Endocrine disruptors, where exposure of humans is negligible | |
(v) | Hazard Weightings applicable to quantities of active substances placed on the market in products authorised under Regulation (EC) No 1107/2009 | ||||||
(vi) | 1 | 8 | 16 | 64 |
the Harmonised Risk Indicator 2 shall be based on the number of authorisations granted under Article 53 of Regulation (EC) No 1107/2009. It shall be calculated on the basis of the categorisation of active substances into the 4 Groups and 7 Categories set out in Table 2 of this Section;
the active substances in Group 1 (categories A and B) are listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011;
the active substances in Group 2 (categories C and D) are those listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011;
the active substances in Group 3 (categories E and F) shall be those listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011;
the active substances in Group 4 (category G) shall be those not approved under Regulation (EC) No 1107/2009, and therefore not listed in the Annex to Implementing Regulation (EU) No 540/2011;
The weightings in row (vi) in Table 2 of this Section shall apply.
Categorisation of active substances and hazard weightings for the purpose of calculating Harmonised Risk Indicator 2
Row | Groups | ||||||
---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | ||||
(i) | Low-risk active substances which are approved or deemed to be approved under Article 22 of Regulation (EC) No 1107/2009, and which are listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011 | Active substances approved or deemed to be approved under Regulation (EC) No 1107/2009, and not falling in other categories, and which are listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011 | Active substances approved or deemed to be approved under Article 24 of Regulation (EC) No 1107/2009, which are candidates for substitution, and which are listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011 | Active substances which are not approved under Regulation (EC) No 1107/2009, and therefore which are not listed in the Annex to Implementing Regulation (EU) No 540/2011 | |||
(ii) | Categories | ||||||
(iii) | A | B | C | D | E | F | G |
(iv) | Micro-organisms | Chemical active substances | Micro-organisms | Chemical active substances | Which are not classified as: Carcinogenic Category 1A or 1B and/or Toxic for Reproduction Category 1A or 1B and/or Endocrine disruptors | Which are classified as: Carcinogenic Category 1A or 1B and/or Toxic for Reproduction Category 1A or 1B and/or Endocrine disruptors where exposure of humans is negligible | |
(v) | Hazard Weightings applicable to the number of authorisations granted under Article 53 of Regulation (EC) No 1107/2009 | ||||||
(vi) | 1 | 8 | 16 | 64 |
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).
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