Annex

IUPAC Name:

(3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3-ol

EC No: 200-673-2

CAS No: 67-97-0

Cholecalciferol is considered a candidate for substitution in accordance with points (a) and (e) of Article 10(1) of Regulation (EU) No 528/2012.

The authorisations of biocidal products are subject to the following general conditions:

1. (1)

   The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. In addition, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) No 528/2012 can be satisfied.

2. (2)

   Products shall only be authorised for use in Member States where at least one of the conditions set out in Article 5(2) of Regulation (EU) No 528/2012 is satisfied.

3. (3)

   According to point (d) of Article 19(4) of Regulation (EU) No 528/2012, products shall not be authorised for making available on the market for use by the general public.

4. (4)

   The nominal concentration of cholecalciferol in the products shall not exceed 0,075 % w/w.

5. (5)

   Products shall contain an aversive agent and a dye.

6. (6)

   Products shall not be authorised in the form of tracking powder.

7. (7)

   Products in the form of contact formulations, other than tracking powder, shall only be authorised for use by trained professionals indoors in places not accessible to children or non-target animals.

8. (8)

   Only ready-to-use products shall be authorised.

9. (9)

   Primary as well as secondary exposure of humans, non-target animals and the environment shall be minimised, by considering and applying all appropriate and available risk mitigation measures. They include for example the restriction to professional or trained professional use when possible and setting additional specific conditions per user category.

10. (10)

    Dead bodies and uneaten bait shall be disposed of in accordance with local requirements. The method of disposal shall be described specifically in the summary of the product characteristics of the national authorisation and be reflected on the product label.

In addition to the general conditions, the authorisations of biocidal products to be used by trained professionals are subject to the following conditions:

1. (1)

   Products may be authorised for use in sewers, open area or waste dumps.

2. (2)

   Products may be authorised for use in covered and protected bait points as long as they provide the same level of protection for non-target species and humans as tamper-resistant bait stations.

3. (3)

   Products may only be authorised for use in permanent treatments at sites with a high potential for reinvasion when other methods of control have proven insufficient.

4. (4)

   Products shall not be authorised for use in pulse baiting treatments.

5. (5)

   Persons making available on the market products for trained professional users shall make sure that those products are not supplied to other persons than trained professionals.

In addition to the general conditions, the authorisations of biocidal products to be used by professionals are subject to the following conditions:

1. (1)

   Products shall not be authorised for use in sewers, open area or waste dumps.

2. (2)

   Products shall not be authorised for use as a permanent bait or pulse baiting treatments.

3. (3)

   Products shall only be authorised for use in tamper-resistant bait stations.

4. (4)

   Persons making available on the market products for professional users shall make sure that those products are not supplied to the general public.