Corrigendum to Commission Directive 90/128/EEC of 23 February 1990 relating to plastics materials and articles intended to come into contact with foodstuffs (Official Journal of the European Communities No L 75 of 21 March 1990)

On page 19 et seg., the text of the Directive is hereby replaced by the following:

'COMMISSION DIRECTIVE of 23 February 1990 relating to plastics materials and articles intended to come into contact with foodstuffs (90/128/EEC) THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (1), and in particular Article 3 thereof,

Whereas Article 2 of Directive 89/109/EEC lays down that materials and articles, in their finished state, must not transfer their constituents to foodstuffs in quantities which could endanger human health or bring about an unacceptable change in the composition of the foodstuffs;

Whereas, in order to achieve this objective in the case of plastics materials and articles, a suitable instrument is a specific Directive within the meaning of Article 3 of Directive 89/109/EEC, the general provisions of which are also applicable to the case in question;

Whereas the scope of this Directive must coincide with that of Council Directive 82/711/EEC (2);

Whereas since the rules established in this Directive are not suitable for ion-exchange resins, these materials and articles will be covered by a subsequent specific Directive;

Whereas the establishment of a list of approved substances accompanied by a limit on overall migration and, where necessary, by other specific restrictions will be sufficient to achieve the objective laid down in Article 2 of Directive 89/109/EEC;

Whereas the stage reached in the work at Community level does not yet permit adoption of a complete list of the authorized substances applicable to all types of plastics materials and articles and therefore the substances which are currently used in at least one Member State can continue to be used pending a decision on inclusion in the Community list; whereas this Directive will accordingly be extended in due course to the substances and sectors provisionally excluded;

Whereas the overall migration limit is a measure of the inertness of the material and prevents an unacceptable change in the composition of the foodstuffs, and, moreover, reduces the need for a large number of specific migration limits or other restrictions, thus giving effective control;

Whereas Directive 82/711/EEC lays down the basic rules necessary for testing migration of the constituents of plastics materials and articles and Council Directive 85/572/EEC (3) establishes the list of simulants to be used in the migration tests;

Whereas Council Directive 78/142/EEC (1) lays down limits for the quantity of vinyl chloride present in plastics materials and articles prepared with this substance and for the quantity of vinyl chloride released by these materials and articles, and Commission Directives 80/766/EEC (2) and 81/432/EEC (3) establish the Community methods of analysis for controlling these limits;

Whereas Commission Directive 80/590/EEC (4) determines the symbol that may accompany any material and article intended to come into contact with foodstuffs;

Whereas in view of potential liability, there is a need for the written declaration provided for in Article 6 (5) of Directive 89/109/EEC whenever professional use is made of plastics materials and articles which are not by their nature clearly intended for food use;

Whereas, in accordance with Article 3 of Directive 89/109/EEC, the Scientific Committee for Food has been consulted on the provisions liable to affect public health;

Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,

HAS ADOPTED THIS DIRECTIVE:

Article 1 1. This Directive is a specific Directive within the meaning of Article 3 of Directive 89/109/EEC.

2. This Directive shall apply to plastics materials and articles and parts thereof:

(a) consisting exclusively of plastics; or (b) composed of two or more layers of materials, each consisting exclusively of plastics, which are bound together by means of adhesives or by any other means,

which, in the finished product state, are intended to come into contact or are brought into contact with foodstuffs and are intended for that purpose.

3. For the purposes of this Directive, 'plastics` shall mean the organic macromolecular compounds obtained by polymerization, polycondensation, polyaddition or any other similar process from molecules with a lower molecular weight or by chemical alteration of natural macromolecules. Silicones and other similar macromolecular compounds shall also be regarded as plastics. Other substances or matter may be added to such macromolecular compounds.

However, the following shall not be regarded as 'plastics`:

(i) varnished or unvarnished regenerated cellulose film, covered by Council Directive 83/229/EEC (5), as amended by Directive 86/388/EEC (6);

(ii) elastomers and natural and synthetic rubber;

(iii) paper and paperboard, whether modified or not by the addition of plastics;

(iv) surface coatings obtained from:

- paraffin waxes, including synthetic paraffin waxes, and/or micro-crystalline waxes,

- mixtures of the waxes listed in the first indent with each other and/or with plastics;

(v) ion-exchange resins.

4. This Directive shall not apply, until further action by the Commission, 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 foodstuffs does consist exclusively of plastics.

Article 2 Plastics materials and articles shall not transfer their constituents to foodstuffs in quantities exceeding 10 milligrams per square decimetre of surface area of material or article (mg/dm2) (overall migration limit). However, this limit shall be 60 milligrams of the constituents released per kilogram of foodstuff (mg/kg) in the following cases:

(a) articles which are containers or are comparable to containers or which can be filled, with a capacity of not less than 500 millilitres (ml) and not more than 10 litres (l);

(b) articles which can be filled and for which it is impracticable to estimate the surface area in contact with foodstuffs;

(c) caps, gaskets, stoppers or similar devices for sealing.

Article 3 1. Only those monomers and other starting substances listed in Annex II, Sections A and B may be used for the manufacture of plastics materials and articles subject to the restrictions specified.

2. From the date of notification of this Directive, the list in Annex II, Section A may be amended:

- either by adding substances listed in Annex II, Section B, according to the criteria in Annex II of Directive 89/109/EEC, or - by including 'new substances`, i.e. substances which are listed neither in Section A nor in Section B of Annex II, according to Article 3 of Directive 89/109/EEC.

3. From the date of notification of this Directive no Member State shall authorize any new substance for use within its territory except under the procedure in Article 4 of Directive 89/109/EEC.

4. As from 1 January 1993, only those monomers and other starting substances listed in Annex II, Section A shall be used for the manufacture of plastics materials and articles, subject to the restrictions specified therein. However, before 1 January 1992 it may be decided that, in some justified cases, for certain substances listed in Annex II, Section B, this time limit will be postponed.

5. However the lists appearing in Annex II, Sections A and B do not yet include monomers and other starting substances used only in the manufacture of:

- surface coatings obtained from resinous or polymerized products in liquid, powder or dispersion form, such as varnishes, lacquers, paints, etc.,

- silicones,

- epoxy resins,

- products obtained by means of bacterial fermentation,

- adhesives and adhesion promoters,

- printing inks.

Article 4 The specific migration limits in the list set out in Annex II are expressed in mg/kg. However, such limits are expressed in mg/dm2 in the following cases:

(a) articles which are containers or are comparable to containers or which can be filled, with a capacity of less than 500 ml or more than 10 l;

(b) sheet, film or other materials which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of such materials and the quantity of foodstuff in contact therewith.

In these cases, the limits set out in Annex II, expressed in mg/kg shall be divided by the conventional conversion factor of 6 in order to express them in mg/dm2.

Article 5 1. Verification of compliance with the migration limits shall be carried out in accordance with the rules laid down in Directives 82/711/EEC and 85/572/EEC and the further provisions set out in Annex I.

2. The verification of compliance with the specific migration limits provided for in paragraph 1 shall not be compulsory, if it can be established that compliance with the overall migration limit laid down in Article 2 implies that the specific migration limits are not exceeded.

Article 6 1. At the marketing stages other than the retail stages, the plastics materials and articles which are intended to be placed in contact with foodstuffs shall be accompanied by a written declaration in accordance with Article 6 (5) of Directive 89/109/EEC.

2. Paragraph 1 does not apply to plastics materials and articles which by their nature are clearly intended to come into contact with foodstuffs.

Article 7 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1990. They shall forthwith inform the Commission thereof.

2. Member States shall:

- permit the trade in and use of plastics materials and articles complying with this Directive before 1 January 1991,

- prohibit trade in and use of plastics materials and articles intended to come into contact with foodstuffs and which do not comply with this Directive as from 1 January 1993.

Article 8 This Directive is addressed to the Member States.

Done at Brussels, 23 February 1990.

For the Commission Martin BANGEMANN Vice-President ANNEX I FURTHER PROVISIONS APPLICABLE WHEN CHECKING COMPLIANCE WITH THE MIGRATION LIMITS General provisions 1. When comparing the results of the migration tests specified in the Annex to Directive 82/711/EEC, the specific gravity of all the simulants should conventionally be assumed to be 1. Milligrams of substance(s) released per litre of simulant (mg/l) will thus correspond numerically to milligrams of substance(s) released per kilogram of simulant and, taking into account the provisions laid down in Directive 85/572/EEC, to milligrams of substance(s) released per kilogram of foodstuff.

2. Where the migration tests are carried out on samples taken from the material or article or on samples manufactured for the purpose, and the quantities of foodstuff or simulant placed in contact with the sample differ from those employed in the actual conditions under which the material or article is used, the results obtained should be corrected by applying the following formula: >TABLE POSITION>

Where: >TABLE>

3. The determination of migration is carried out on the material or article or, if that is impracticable, using either specimens taken from the material or article or, where appropriate, specimens representative of this material or article.

The sample shall be placed in contact with the foodstuff or simulant in a manner representing the contact conditions in actual use. For this purpose, the test shall be performed in such a way that only those parts of the sample intended to come into contact with foodstuffs in actual use will be in contact with the foodstuff or simulant. This condition is particularly important in the case of materials and articles comprising several layers, for closures, etc.

The migration testing of caps, gaskets, stoppers or similar devices for sealing must be carried out on these articles by applying them to the containers for which they are intended in a manner which corresponds to the conditions of closing in normal or foreseeable use.

It shall in all cases be permissible to demonstrate compliance with migration limits by the use of a more severe test.

4. In accordance with the provisions set out in Article 5 of the present Directive, the sample of the material or article is placed in contact with the foodstuff or appropriate simulant for a period and at a temperature which are chosen by reference to the contact conditions in actual use, in accordance with the rules laid down in Directives 82/711/EEC and 85/572/EEC. At the end of the prescribed time,. the analytical determination of the total quantity of substances (overall migration) and/or the specific quantity of one or more substances (specific migration) released by the sample is carried out on the foodstuff or simulant.

5. Where a material or article is intended to come into repeated contact with foodstuffs, the migration test(s) shall be carried out three times on a single sample in accordance with the conditions laid down in Directive 82/711/EEC using another sample of the food or simulant(s) on each occasion. Its compliance shall be checked on the basis of the level of the migration found in the third test. However, if there is conclusive proof that the level of the migration does not increase in the second and third tests and if the migration limit(s) is (are) not exceeded on the first test, no further test is necessary.

Special provisions relating to overall migration 6. If the aqueous simulants specified in Directives 82/711/EEC and 85/572/EEC are used, the analytical determination of the total quantity of substances released by the sample may be carried out by evaporation of the simulant and weighing of the residue.

If rectified olive oil or any of its substitutes is used, the procedure given below may be followed.

The sample of the material or article is weighed before and after contact with the simulant. The simulant absorbed by the sample is extracted and determined quantitatively. The quantity of simulant found is subtracted from the weight of the sample measured after contact with the simulant. The difference between the initial and corrected final weights represents the overall migration of the sample examined.

Where a material or article is intended to come into repeated contact with foodstuffs and it is technically impossible to carry out the test described in paragraph 5, modifications to that test are acceptable, provided that they enable the level of migration occurring during the third test to be determined. One of these possible modifications is described below.

The test is carried out on three identical samples of the material or article. One of these shall be subjected to the appropriate test and the overall migration determined (M1). The second and third samples shall be subjected to the same conditions of temperature but the period of contact shall be two and three times that specified and overall migration determined in each case (M2 and M3, respectively).

The material or article shall be deemed to be in compliance provided that either M1 or M3 PM2 do not exceed the overall migration limit.

7. A material or article that exceeds the overall migration limit by an amount not greater than the analytical tolerance mentioned below should therefore be deemed to be in compliance with this Directive.

The following analytical tolerances have been observed:

- 20 mg/kg or 3 mg/dm2 in migration tests using rectified olive oil or substitutes,

- 6 mg/kg or 1 mg/dm2 in migration tests using the other simulants referred to in Directives 82/711/EEC and 85/572/EEC.

8. Without prejudice to the provisions of Article 3 (2) of Directive 82/711/EEC, migration tests using rectified olive oil or substitutes shall not be carried out to check compliance with the overall migration limit in cases where there is conclusive proof that the specified analytical method is inadequate from a technical standpoint.

In any such case, for substances exempt from specific migration limits or other restrictions in the list provided in Annex II, a generic specific migration limit of 60 mg/kg or 10 mg/dm2, according to the case, is applied. However the sum of all specific migrations determined shall not exceed the overall migration limit.

ANNEX II LIST OF MONOMERS AND OTHER STARTING SUBSTANCES WHICH MAY BE USED IN THE MANUFACTURE OF PLASTIC MATERIALS AND ARTICLES General introduction 1. This Annex contains the list of monomers or other starting substances. The list includes:

- substances undergoing polymerization, which includes polycondensation, polyaddition or any other similar process, to manufacture macromolecules,

- natural or synthetic macromolecular substances used in the manufacture of modified macromolecules, if the monomers or the other starting substances required to synthesize them are not included in the list,

- substances used to modify existing natural or synthetic macromolecular substances.

2. The list does not include the salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc of the authorized acids, phenols or alcohols which are also authorized. However, names containing '. . . acid(s), salts` appear in the lists if the corresponding free acid(s) is (are) not mentioned. In such cases the meaning of the term 'salts` is 'salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc`.

3. The list also does not include the following substances although they may be present:

(a) substances which could be present in the finished product as:

- impurities in the substances used,

- reaction intermediates,

- decomposition products;

(b) oligomers and natural or synthetic macromolecular substances as well as their mixtures, if the monomers or starting substances required to synthesize them are included in the list;

(c) mixtures of the authorized substances.

The materials and articles which contain the substances indicated under (a), (b) and (c) shall comply with the requirements stated in Article 2 of Directive 89/109/EEC.

4. Substances shall be of good technical quality.

5. The list contains the following information:

- column 1 (PM/REF. No): the EEC packaging material reference number of the substances on the list,

- column 2 (CAS No): the CAS (Chemical Abstracts Service) Registry number,

- column 3 (Name): the chemical name,

- column 4 (Restrictions). These may include:

- specific migration limit (SML),

- maximum permitted quantity of the 'residual` substance in the material or article (QM),

- any other restriction specifically mentioned.

6. If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions applying to this substance shall be those indicated for the individual compound.

7. Where there is any inconsistency between the CAS number and the chemical name, the chemical name shall take precedence over the CAS number. If there is an inconsistency between the CAS number reported in EINECS and the CAS Registry, the CAS number in the CAS Registry shall apply.

8. A number of abbreviations or expressions are used in column 4 of the table, the meanings of which are as follows: >TABLE>

SECTION A LIST OF AUTHORIZED MONOMERS AND OTHER STARTING SUBSTANCES >TABLE>

SECTION B LIST OF MONOMERS AND OTHER STARTING SUBSTANCES WHICH MAY CONTINUE TO BE USED PENDING A DECISION ON INCLUSION IN SECTION A >TABLE>

>TABLE>