(b) paragraph 4 is replaced by the following:
Directive shall not apply to materials and articles
composed of two or more layers, one or more of
which does not consist exclusively of plastics, even if
the one intended to come into direct contact with food-
stuffs does consist exclusively of plastics.
2. The following Article 1a is inserted:
For the purpose of this Directive the following definitions
"plastic multi-layer material or article" means a plastic
material or article composed of two or more layers of
materials, each consisting exclusively of plastics, which
are bound together by means of adhesives or by other
"plastic functional barrier" means a barrier consisting of
one or more layers of plastics which ensures that the
finished material or article complies with Article 3 of
Regulation (EC) No 1935/2004 of the European
Parliament and of the Council (*) and with this
"non-fatty foods" means foods for which in migration
testing simulants other than simulant D are laid down
in Directive 85/572/EEC.
(*) OJ L 338, 13.11.2004, p. 4.
3. Article 2 is replaced by the following:
Plastic materials and articles shall not transfer their
constituents to foodstuffs in quantities exceeding 60
milligrams of the constituents released per kilogram of
foodstuff or food simulant (mg/kg) (overall migration limit).
However, this limit shall be 10 milligrams per square
decimetre of surface area of material or article (mg/dm
in the case of the following:
(a) articles which are containers or are comparable to
containers or which can be filled, with a capacity of
less than 500 millilitres (ml) or more than 10 litres (l);
(b) sheet, film or other material or articles which cannot be
filled or for which it is impracticable to estimate the
relationship between the surface area of such material
or article and the quantity of food in contact therewith.
For plastic materials and articles intended to be
brought into contact with or already in contact with food
intended for infants and young children, as defined by
Commission Directives 91/321/EEC (*) and 96/5/EC (**),
the overall migration limit shall always be 60 mg/kg.
(*) OJ L 175, 4.7.1991, p. 35.
(**) OJ L 49, 28.2.1996, p. 17.
4. In Article 4(2), the date of
`1 July 2006' is replaced by `1
5. The following Articles 4c, 4d and 4e are inserted:
For the use of additives for the manufacture of plastic layers
or plastic coatings in lids referred to in Article 1(2)(c), the
following rules shall apply:
(a) for the additives listed in Annex III, the restrictions
and/or specifications on their use set out in that
Annex shall apply, without prejudice to Article 4(2);
(b) by way of derogation from Article 4(1) and Article
4a(1) and (5), additives not listed in Annex III may
continue to be used, until further review, subject to
(c) by way of derogation from Article 4b Member States
may continue to authorise additives for the manu-
facture of plastic layers or plastic coatings in lids
referred to in Article 1(2)(c) at national level.
For the use of additives exclusively acting as polymerisation
production aids which are not intended to remain in the
finished article (hereinafter PPAs), for the manufacture of
plastic materials and articles, the following rules shall apply:
(a) for the PPAs listed in Annex III, the restrictions and/or
specifications on their use set out in Annex III shall
apply, without prejudice to Article 4(2);
Official Journal of the European Union