7.3.2008   

EN

Official Journal of the European Union

L 63/6

(1)

Commission Directive 2002/72/EC (2) is a specific Directive within the meaning of Regulation (EC) No 1935/2004 and harmonises the rules on the authorisation of plastic materials and articles intended to come into contact with food.

(2)

Directive 2002/72/EC establishes lists of authorised substances for the manufacture of these materials and articles, in particular additives and monomers, restrictions on their use, as well as rules on labelling and on the information to be given to consumers or food business operators for the correct use of these materials and articles.

(3)

The current list of additives contained in Directive 2002/72/EC is an incomplete list inasmuch as it does not contain all substances currently accepted in one or more Member States.

(4)

According to Article 4(1) of Directive 2002/72/EC as it stands, the list of additives is considered to be an incomplete list until the Commission decides, in accordance with Article 4a, that it becomes a positive Community list of authorised additives.

(5)

For those additives which are currently permitted in the Member States, the time limit for the submission of data for their safety evaluation by the European Food Safety Authority (hereinafter the Authority) with a view to their inclusion in the Community list expired on 31 December 2006. Therefore the date when the Community list of additives becomes a positive list can now be set. Taking into account the time the Authority will need to evaluate all valid applications submitted on time this date should be January 2010.

(6)

It is also appropriate to clarify the role of the provisional list referred to in Article 4a (4) and (5) of Directive 2002/72/EC as it stands and how it will be updated. The provisional list contains those additives for which the necessary data were supplied on time and in accordance with the Authority’s requirements, but where no decision on their inclusion in the positive list has yet been taken.

(7)

This provisional list provides information to the public on the additives that are under evaluation in view of their possible inclusion in the Community list of additives. As it is impossible to know if the evaluations for all the additives included in the provisional list will be completed by the date when the list of additives becomes a positive list, it should be possible to continue to use those additives, in accordance with national law, until their evaluation is completed and a decision is taken on their inclusion in the positive list of additives.

(8)

When an additive included in the provisional list is inserted in the Community list of additives or when it is decided not to include it in the Community list, that additive should be removed from the provisional list of additives.

(9)

If, during the examination of the data on an additive included in the provisional list, the Authority calls for supplementary information, that additive should be maintained in the provisional list until a decision is taken in relation to it, provided that the information is submitted within the time limits specified by the Authority.

(10)

On the basis of new information related to the risk assessment of monomers and additives evaluated by the Authority (3), certain additives admitted at national level as well as new monomers and additives should be included in the respective Community lists of authorised substances. For other substances, the restrictions and/or specifications already established at Community level should be amended on the basis of this new information. Therefore, Annexes II, III, IVa, V and VI of Directive 2002/72/EC should be amended accordingly.

(11)

Commission Directive 2005/79/EC (4) introduced in the list of additives the additive Ref. No 30340 with the name 12-(Acetoxy)stearic acid, 2,3-bis(acetoxy)propyl ester and CAS number 330198-91-9. The name and CAS number introduced in that Directive reflect only the main component of the application. However the opinion delivered by the Authority covers the mixture of substances referred to in the application and not only its main component. The mixture of substances is now registered in the CAS register under CAS number 736150-63-3 with the name Glycerides, castor-oil mono-, hydrogenated, acetates. For this reason it is now appropriate to change the name and CAS number to update the authorisation to all substances in the mixture. Taking into account the change of name a new Ref. No 55910 is assigned. As the substance is now covered by Ref. No 55910, Ref. No 30340 should be deleted.

(12)

As a consequence, Directive 2002/72/EC should be updated to take account of new information related to the risk assessment of substances evaluated by the Authority, to establish the date when the list of additives becomes a positive list and to clarify the role of the provisional list of additives.

(13)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

1.

In Article 4, paragraph 1 is replaced by the following:

‘1.   A Community list of additives which may be used for the manufacture of plastic materials and articles, together with the restrictions and/or specifications on their use, is set out in Annex III.

Until 31 December 2009, additives which are not included in the Community list of additives may continue to be used subject to national law.

As from 1 January 2010, only additives included in the Community list of additives may be used for the manufacture of plastic materials and articles (positive list).’

2.

Article 4a is amended as follows:

3.

Annexes II, III, IVa, V and VI are amended in accordance with Annexes I, II, III, IV and V to this Directive.

(a)

permit the trade in and use of plastic materials and articles intended to come into contact with food and complying with Directive 2002/72/EC, as amended by this Directive, from 7 March 2009;

(b)

prohibit the manufacture and importation into the Community of plastic materials and articles intended to come into contact with food and which do not comply with Directive 2002/72/EC, as amended by this Directive, from 7 March 2010.