4.6.2015   

EN

Official Journal of the European Union

L 137/1

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

Potassium iodide and calcium iodate anhydrous were authorised without a time limit by Directive 70/524/EEC as amended by Commission Regulation (EC) No 1459/2005 (3). These products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, applications were submitted for the re-evaluation of potassium iodide and calcium iodate anhydrous as feed additives for all animal species. Additionally, an application based on Article 10(2) was submitted for the re-evaluation of calcium iodate anhydrous in a film granulated form for all animal species. For the three compounds of iodine, the applicants requested that the additives be classified in the additive category ‘nutritional additives’. The applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions published on 19 May 2014 (4)  (5)  (6)  (7) that, under the proposed conditions of use, potassium iodide, calcium iodate anhydrous and coated granulated calcium iodate anhydrous do not have an adverse effect on animal health, consumer health or the environment.

(5)

The Authority further concluded that potassium iodide, calcium iodate anhydrous and coated granulated calcium iodate anhydrous are effective sources of iodine in the respective target species and that no safety concerns would arise for users provided that appropriate protective measures are taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6)

The assessment of potassium iodide, calcium iodate anhydrous and coated granulated calcium iodate anhydrous shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of these substances and preparations should be authorised as specified in the Annex to this Regulation.

(7)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for potassium iodide and calcium iodate anhydrous, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

4.6.2015   

EN

Official Journal of the European Union

L 137/8

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

4.6.2015   

EN

Official Journal of the European Union

L 137/10

(1)

Directive 2011/65/EU lays down rules on the restriction of the use of hazardous substances in electrical and electronic equipment (EEE) with a view to contributing to the protection of human health and the environment, including the environmentally sound recovery and disposal of waste EEE.

(2)

Directive 2011/65/EU prohibits the use of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE) in electrical and electronic equipment placed on the Union market. Annex II to that Directive lists those restricted substances.

(3)

The risks to human health and the environment arising from the use of Hexabromocyclododecane (HBCDD), Bis(2-ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP) and Dibutyl phthalate (DBP) should be considered a priority in the periodic review of the list of restricted substances in Annex II. With a view to further restrictions, the substances that were subject to previous assessments should be re-investigated.

(4)

In accordance with Article 6(1) of Directive 2011/65/EU, interested parties, including economic operators, recyclers, treatment operators, environmental organisations and employee and consumer associations, have been consulted and a thorough assessment has been performed.

(5)

Bis(2-ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP), Dibutyl phthalate (DBP) and Diisobutyl phthalate (DIBP) are substances of very high concern (SVHC). DIBP is a substance that can be used as a substitute for DBP and was subject to previous assessments performed by the Commission. The available evidence indicates that those four substances, when used in EEE, can have a negative impact on recycling and on human health and the environment during EEE waste management operations.

(6)

Substitutes that have less negative impacts are available for DEHP, BBP, DBP and DIBP in most EEE. The use of those substances in EEE should therefore be restricted. DEHP, BBP and DBP are already restricted through entry 51 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council, (2) so that toys containing DEHP, BBP or DBP in a concentration greater than 0,1 % by weight of the plasticised material, calculated for the three phthalates cumulatively, cannot be placed on the EU market. In order to avoid double regulation, the restriction through entry 51 of Annex XVII to that Regulation shall therefore continue to be the only restriction applicable to DEHP, BBP and DBP in toys.

(7)

In order to facilitate transition and to mitigate possible socioeconomic impacts, an appropriate transition period should be granted, which will allow economic operators to apply for exemptions from the substance restrictions in accordance with Article 5 of Directive 2011/65/EU. The longer innovation cycles for medical devices and monitoring and control instruments should be taken into account while determining the transitional period. The restriction of the use of DEHP, BBP, DBP and DIBP should therefore apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from 22 July 2021.

(8)

Any adaptation of Annex III or IV to Directive 2011/65/EU to exempt applications in relation to DEHP or DBP should take place in a manner which, in order to avoid double regulation and unnecessary burden, ensures coherence with the administration of any authorisation granted under Regulation (EC) No 1907/2006 in relation to the incorporation of those substances in EEE. Operators considering whether to apply for exemptions under Directive 2011/65/EU should be aware that such exemptions may cover the entire life cycle of the EEE, including the manufacturing phase.

(9)

Directive 2011/65/EU should therefore be amended accordingly,

4.6.2015   

EN

Official Journal of the European Union

L 137/13