1982L0711 — EN — 22.03.1993 — 001.001 — 1
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►B COUNCIL DIRECTIVE
of 18October 198 2
laying down the basic rules necessary for testing migration of the constituents of plastic materials
and articles intended to come into contact with foodstuffs
(82/711/EEC)
(OJ L 297, 23.10.1982, p. 26)
Amended by:
OfficialJournal
No page date
►M1 Commission Directive 93/8/EEC of 15 March 1993 L 90 22 14.4.1993
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▼B
COUNCIL DIRECTIVE
of 18October 198 2
laying down the basic rules necessary for testing migration of the
constituents of plastic materials and articles intended to come into
contact with foodstuffs
(82/711/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community,
Having regard to CouncilDirective 76/893/EEC of 23 November 1976
on the approximation of the laws of the Member States relating tomaterials and articles intended to come into contact with foodstuffs (
1),
and in particular Article 3 thereof,
Having regard to the proposalfrom the Commission,Having regard to the opinion of the European Parliament (
2),
Having regard to the opinion of the Economic and SocialCommittee (3),
Whereas Article 2 of Directive 76/893/EEC laid down inter alia that
materials and articles must not transfer their constituents to foodstuffs inquantities which could endanger human health or bring about an unac-ceptable change in the composition of the foodstuffs;
Whereas in order to achieve this objective in the case of plastic mate-
rials the suitable instrument is a specific directive within the meaning ofArticle 3 of Directive 76/893/EEC, the general rules of which shall alsobe applicable to the case in question;
Whereas, given the complexity of the problem, the Directive should
initially be limited to fixing the basic rules for verification of constit-uent migration; whereas further directives, to be adopted in accordancewith the procedure laid down in Article 10 of Directive 76/893/EEC,will establish the methods of analysis necessary for the verification ofsuch migration;
Whereas this Directive does not affect all aspects of plastic materials
and articles; whereas it is therefore necessary to authorize the MemberStates, on the one hand, not to impose the labelling particulars laiddown in Article 7 of Directive 76/893/EEC in accordance with para-graphs 4 and 5 of that Article and, on the other hand, to prohibit themarketing of materials and articles which, although conforming with thestandards laid down by that Directive, do not comply with nationalprovisions regarding other possible standards referred to in Article 3 orin the absence of these, with Article 2 of the Directive in question;
Whereas, in view of the analytical difficulties connected with the deter-
mination of the migration levels in food products, conventional testsshould be chosen (liquids capable of simulating the attack on foodstuffsand standard test conditions) in order to reproduce, as far as possible,the migration phenomena which may occur in contact between thearticle and the foodstuff;
Whereas if such tests subsequently prove not to reflect reality Member
States should be authorized to amend them provisionally, pending aCommunity decision;
Whereas, in the current state of analytical techniques, it is not possible
to determine al lthe conditions under which conventionalmigration testsshould be performed on materials and articles consisting of two or morelayers, one or more of which does not consist entirely of plastics;
(1) OJ No L 340, 9. 12. 1976, p. 19.
(2) OJ No C 140, 5. 6. 1979, p. 173.
(3) OJ No C 227, 10. 9. 1979, p. 31.
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▼B
whereas a decision on the application of this Directive to such materials
and articles should therefore be taken at a later date;
Whereas the adaptation of this Directive to technicalprogress is an
implementing measure; whereas, in order to simplify and accelerate theprocedure, this should be the responsibility of the Commission;
Whereas in al lcases in which the Councilconfers on the Commission
authority to implement the provisions relating to plastic materials andarticles intended to come into contact with foodstuffs, a procedureshould be laid down establishing close cooperation between MemberStates and the Commission within the Standing Committee for Food-stuffs set up under Decision 69/414/EEC (
1),
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive is a specific Directive within the meaning of Article
3 of Directive 76/893/EEC.
2. This Directive shall apply to plastic materials and articles, that is
to say to 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 ofadhesives 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 thatpurpose.
3. For the purposes of this Directive, ‘plastics'shall mean the organic
macromolecular compounds obtained by polymerization, polycondensa-tion, polyaddition or any other similar process from molecules with alower molecular weight or by chemical alteration of natural macromole-cules. Silicones and other similar macromolecular compounds shall alsobe regarded as plastics. Other substances or matter may be added tosuch macromolecular compounds.
However, the following shall not be regarded as ‘plastics':
(i) varnished or unvarnished regenerated cellulose film;
(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.
4. This Directive shall not apply to materials and articles composed
or two or more layers, one or more of which does not consist exclu-sively of plastics, even if the one intended to come into direct contactwith foodstuffs does consist exclusively of plastics.
A decision on the application of this Directive to the materials and
articles referred to in the first subparagraph and on any adaptations tothe Directive that may become necessary shall be taken at a later date.
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Article 2
The overall and specific migration levels of constituents of the materials
and articles referred to in Article 1 into or onto foodstuffs or food
(1) OJ No L 291, 19. 11. 1969, p. 9.
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simulants must not exceed the limits laid down in Commission
Directive 90/128/EEC (1) or in any other relevant specific directive.
Article 3
1. Verification of compliance of migration into foodstuffs with the
migration limits shall be carried out under the most extreme conditionsof time and temperature foreseeable in actual use.
Verification of compliance of migration into food simulants with the
migration limits shall be carried out using conventional migration tests,the basic rules for which are laid down in the Annex to this Directive.
2. (a) However, where a Member State, as a result of new information
or of a reassessment of existing information made since thisDirective was adopted, has detailed grounds for establishing thatfor a given plastic material or article the basic rules laid down inthe Annex for migration tests are technically unsuitable orbecause the actual conditions of use are basically different fromthe test conditions specified in the table in the Annex, thatMember State may, within its territory and only for the particularcase, temporarily suspend application of the basic rules referredto in the Annex and permit the use of more appropriate basicrules. It shall immediately inform the other Member States andthe Commission thereof and give the reasons for its decision.
(b) The Commission shall examine, as soon as possible, the reasons
given by the Member States concerned and shall consult theMember States within the Standing Committee for Foodstuffsand shall then deliver its opinion forthwith and amend thisDirective, if necessary. In that case, the Member State which hasadopted the more appropriate basic rules may retain them untilthe said amendments enter into force.
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B
Article 4
Adaptations to be made to Chapter II of the Annex to this Directive in
the light of progress in scientific and technical knowledge shall beadopted in accordance with the procedure laid down in Article 10 ofDirective 76/893/EEC.
Article 5
This Directive shal lnot affect nationalprovisions rel ating to the other
rules provided for in Article 3 of Directive 76/893/EEC nor the optionsopen to Member States under Article 7 (4) and (5) of that Directive.
Article 6
Member States shall comply with this Directive not later than such time
as a specific directive laying down the limits referred to in Article 2 (1)is implemented.
Article 7
This Directive is addressed to the Member States.
(1) OJ No L 75, 21. 3. 1990, p. 19, amended by OJ No L 349, 13. 12. 1990,
p. 26.
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ANNEX
BASIC RULES FOR TESTING MIGRATION IN FOOD SIMULANTS
The determination of migration in food simulants shall be carried out using the
food simulants laid down in Chapter I of Annex and under the test conditionsspecified in Chapter II of Annex. However the determination of migration shallbe restricted to the food simulant(s) and to the condition(s) of test which, in thespecific case under examination, may be considered to be the most severe on thebasis of experience.
CHAPTER I
Food simulants
1.General case: plastic materials and articles intended to come into contact
with foodstuffs of all types
The tests shall be carried out using the food simulants mentioned below,
taking a fresh sample of the plastic material or article for each simulant:
— distilled water or water of equivalent quality (= simulant A),
— 3 % acetic acid (w/v) in aqueous solution (= simulant B),— 15 % ethanol (v/v) in aqueous solution (= simulant C),— rectified olive oil (
1) (= simulant D); if for technical reasons connected
with the method of analysis it is necessary to use different food simulants,olive oil shall be replaced by a mixture of synthetic triglycerides (
2).or by
sunflower oil. If all the food simulants provided in this indent are inap-propriate, other food simulants and conditions of time and temperaturemay be used.
However, the simulant A shall be used only in the cases mentioned specifi-
cally in the Table of this Annex.
2.Special case: plastic materials and articles intended to come into contact with
a single foodstuff or a specific group of foodstuffs
The tests shall be carried out:— using only the food simulant(s) specified as appropriate for the foodstuff
or group of foodstuffs in the Directive 85/572/EEC (
3),
— where the foodstuff or group of foodstuffs is not included in the list
referred to in the first indent, selecting the food simulant(s) prescribed inSection 1 which correspond most closely to the extractive capacity of thefoodstuff or group of foodstuffs.
CHAPTER II
Test conditions (times and temperatures)
1. The migration tests are to be carried out, selecting from the times and
temperatures specified in the table those which correspond most closely to,but are not less than, the normal or foreseeable conditions of contact for theplastic materials or articles being studied.
2. Where a materialor articl e passes a test at a given time and temperature, it
need not to be tested for a shorter time at the same temperature, nor for thesame time at a lower temperature.
3. However if a plastic material or article is intended for a food contact applica-
tion covered by two or more combinations of time and temperature takenfrom the Table, migration will be determined by subjecting that material orarticle successively to all the applicable test conditions, using the same aliquotof food simulant.
4. If a plastic material or article is intended to come into contact with foodstuffs
at any condition of time, the conditions for testing will be the following:
(1) Characteristics of rectified olive oil:
— iodine index (Wijs) = 80 to 88,— refraction index at 25 °C = 1,4665 to 1,4679,
— acidity (expressed in % of oleic acid) = 0,5 % maximum,— peroxide index (expressed in milli-equivalents of oxygen per kg of oil) = 10
maximum.
(
2) Characteristics of the standard synthetic triglycerides mixture as described in K.
Figge’s article, ‘Food Cosmet. Toxicol' 10 (1972) 81.5.
(3) OJ No L 372, 31. 12. 1985, p. 14.
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Conditions of contact in actualuse Test condition(a) where the plastic material or article may in actual use be employed at any
temperature up to and including 70 °C and that is indicated by an
appropriate labelling or instructions, only the 10 day test(s) at 40 °C shall
be carried out;
(b) where a plastic material or article may in actual use be employed at a
temperature above 70 °C:
(i) where no labelling or instructions are given to indicate temperature
expected in real use, simulants B and C shall be used at refluxtemperature, if possible, or at two-hour test(s) at 100 °C and simulant
D shall be used for two hours at 175 °C;
(ii) where labelling or instructions are given to indicate conditions
expected in real use, time and temperatures from the Table shall beselected.
5. By derogation from the conditions provided in the table and in paragraph 2, if
the plastic material or article may in actual use be employed for periods ofless than 15 minutes at temperatures between 70 °C and 100 °C and that is
indicated by an appropriate labelling or instructions, only the two-hour test at70°C and the 10-day test at 40 °C shall be carried out. These tests shall be
carried out separately taking different samples. For each of these two types oftest, use a new sample of the same material or article to be examined.
6. If it is found that carrying out the tests under the conditions specified in the
table causes physical or other changes in the plastic material or article whichdo not occur under normalof foreseeabl e conditions of use of that materialorarticle, the migration tests shall be carried out under conditions more appro-priate to the specific case.
7. For materials and articles intended for use in microwave ovens, migration
testing shall use a conventional oven and appropriate time and temperatureconditions selected from the Table.
Table
Contact time Test time
t≤0,5 hour 0,5 hour
0,5 hour <t≤1 hour 1 hour
1 hour<t≤2 hours 2 hours
2 hours<t≤24 hours 24 hours
t>24 hours 10 days
Contact temperature Test temperature
T≤5°C5 °C
5°C<T≤20 °C2 0 °C
20 °C<T≤40 °C4 0 °C
40 °C<T≤70 °C7 0 °C
70 °C<T≤100 °C 100 °C or reflux temperature
100 °C<T≤121 °C 121 °C(1)
121 °C<T≤130 °C 130 °C(1)
130 °C<T≤150 °C 150 °C(2)
T>150 °C 175 °C(2)
(1) Use simulant C at reflux temperature.
(2) Use simulant D at 150 °Co r1 7 5 °C, in addition to simulants A, B and C used as appropriate at 100 °Co ra t
reflux temperature.