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Article
7
Where a Member State considers it appropriate, it may provide that
groups or the public shall be consulted on any aspect of the proposed
deliberate release.
Article 8
After completion of a release, the notifier shall send to the competent
authority the result of the release in respect of any risk to human
health or the environment, with particular reference to any kind of
product that the notifier intends to notify at a later stage.
Article 9
1. The Commission shall set up a system of exchange of the information
contained in the notifications. The competent authorities shall send to
the Commission, within 30 days of its receipt, a summary of each
notification
received. The format of this summary will be established by the
Commission in accordance with the procedure laid down in Article 21.
2. The Commission shall immediately forward these summaries to the other
Member States, which may, within 30 days, ask for further information or
present observations through the Commission or directly.
3. The competent authorities shall inform the other Member States and
the Commission of the final decisions taken in compliance with Article 6
(2).
PART C
Placing on the market of products containing GMOs
Article 10
1. Consent may only be given for the placing on the market of products
containing, or consisting of, GMOs, provided that:
- written consent has been given to a notification under Part B or if a
risk analysis has been carried out based on the elements outlined in
that Part;
- the products comply with the relevant Community product legislation;
- the products comply with the requirements of this Part of this
Directive, concerning the environmental risk assessment.
2. Articles 11 to 18 shall not apply to any products covered by
Community legislation which provides for a specific environmental risk
assessment similar to that laid down in this Directive.
3. Not later than 12 months after notification of this Directive, the
Commission, in accordance with the procedure laid down in Article 21,
shall establish a list of Community legislation covering the products
referred to in paragraph 2. This list will be re-examined periodically
and, as necessary, revised in accordance with the said procedure.
Article
11
1. Before a GMO or a combination of GMOs are placed on the market as or
in a product, the manufacturer or the importer to the Community shall
submit a notification to the competent authority of the Member State
where such a product is to be placed on the market for the first time.
This notification shall contain:
- the information required in Annex II, extended as necessary to take
into account the diversity of sites of use of the product, including
information on data and results obtained from research and developmental
releases concerning the ecosystems which could be affected by the use of
the product and an assessent of any risks for human health and the
environment related to the GMOs or a
combination of GMOs contained in the product, including information
obtained from the research and development stage on the impact of the
release on human health and the environment;
- the conditions for the placing on the market of the product, including
specific conditions of use and handling and a proposal for labelling and
packaging which should comprise at least the requirements laid down in
Annex III.
If on the basis of the results of any release notified under Part B of
this Directive, or on substantive, reasoned scientific grounds, a
notifier considers that the placing on the market and use of a product
do not pose a risk to human health and the environment, he may propose
not to comply with one or more of the requirements of Annex III B.
2. The notifier shall include in this notification information on data
or results from releases of the same GMOs or the same combination of
GMOs previously or currently notified and/or carried out by the notifier
either inside or outside the Community.
3. The notifier may also refer to data or results from notifications
previously submitted by other notifiers, provided that the latter have
given their agreement in writing.
4. Each new product which, containing or consisting of the same GMO or
combination of GMOs, is intended for a different use, shall be notified
separately.
5. The notifier may proceed with the release only when he has received
the written consent of the competent authority in accordance with
Article 13, and in conformity with any conditions, including reference
to particular ecosystems/environments, required in that consent.
6. If new information has become available with regard to the risks of
the product to human health or the environment, either before or after
the written consent, the notifier shall immediately:
- revise the information and conditions specified in paragraph 1,
- inform the competent authority, and
- take the measures necessary to protect human health and the
environment.
Article
12
1. On receipt and after acknowledgement of the notification referred to
in Article 11, the competent
authority shall examine it for compliance with this Directive, giving
particular attention to the environmental risk assessment and the
recommended precautions related to the safe use of the product.
2. At the latest 90 days after receipt of the notification, the
competent authority shall either:
(a) forward the dossier to the Commission with a favourable opinion, or
(b) inform the notifier that the proposed release does not fulfil the
conditions of this Directive and that it is therefore rejected.
3. In the case referred to in paragraph 2 (a), the dossier forwarded to
the Commission shall include a summary of the notification together with
a statement of the conditions under which the competent authority
proposes to consent to the placing on the market of the product.
The format of this summary shall be established by the Commission in
accordance with the procedure laid down in Article 21.
In particular where the competent authority has acceded to the request
of the notifier, under the terms of the last subparagraph of Article 11
(1), not to comply with some of the requirements of Annex III B, it
shall at the same time inform the Commission thereof.
4. If the competent authority receives additional information pursuant
to Article 11 (6), it shall immediately inform the Commission and the
other Member States.
5. For the purpose of calculating the 90-day period referred to in
paragraph 2, any periods of time during which the competent authority is
awaiting further information which it may have requested from the
notifier shall not be taken into account.
Article 13
1. On receipt of the dossier referred to in Article 12 (3), the
Commission shall immediately forward it to the competent authorities of
all Member States together with any other information it has collected
pursuant to this Directive and advise the competent authority
responsible for forwarding the document of the distribution date.
2. The competent authority, in the absence of any indication to the
contrary from another Member State within 60 days following the
distribution date referred to in paragraph 1, shall give its consent in
writing to the notification so that the product can be placed on the
market and shall inform the other Member States and the Commission
thereof.
3. In cases where the competent authority of another Member State raises
an objection - for which the reasons must be stated - and should it not
be possible for the competent authorities concerned to reach an
agreement within the period specified in paragraph 2, the Commission
shall take a decision in accordance with the procedure laid down in
Article 21.
4. Where the Commission has taken a favourable decision, the competent
authority that received the original notification shall give consent in
writing to the notification so that the product may be placed on the
market and shall inform the other Member States and the Commission
thereof.
5. Once a product has received a written consent, it may be used without
further notification throughout the Community in so far as the specific
conditions of use and the environments and/or geographical areas
stipulated in these conditions are strictly adhered to.
6. Member States shall take all necessary measures to ensure that users
comply with the conditions of use specified in the written consent.
Article 14
Member States shall take all necessary measures to ensure that products
containing, or consisting of, GMOs will be placed on the market only if
their labelling and packaging is that specified in the written consent
referred to in Articles 12 and 13.
Article 15
Member States may not, on grounds relating to the notification and
written consent of a deliberate release under this Directive, prohibit,
restrict or impede the placing on the market of products containing, or
consisting of, GMOs which comply with the requirements of this
Directive.
Article 16
1. Where a Member State has justifiable reasons to consider that a
product which has been properly notified and has received written
consent under this Directive constitutes a risk to human health or the
environment, it may provisionally restrict or prohibit the use and/or
sale of that product on its territory. It shall immediately inform the
Commission and the other Member States of such action and give reasons
for its decision.
2. A decision shall be taken on the matter within three months in
accordance with the procedure laid down in Article 21.
Article 17
The Commission shall publish in the Official Journal of the European
Communities a list of all the products receiving final written consent
under this Directive. For each product, the GMO or GMOs contained
therein and the use or uses shall be clearly specified.
Article 18
1. Member States shall send to the Commission, at the end of each year,
a brief factual report on the control of the use of all products placed
on the market under this Directive.
2. The Commission shall send to the European Parliament and the Council,
every three years, a report on the control by the Member States of the
products placed on the market under this Directive.
3. When submitting this report for the first time, the Commission shall
at the same time submit a specific report on the operation of this Part
of this Directive including an assessment of all its implications.
PART D
Final provisions
Article 19
1. The Commission and the competent authorities shall not divulge to
third parties any confidential information notified or exchanged under
this Directive and shall protect intellectual property rights relating
to the data received.
2. The notifier may indicate the information in the notification
submitted under this Directive, the disclosure of which might harm his
competitive position, that should therefore be treated as confidential.
Verifiable justification must be given in such cases.
3. The competent authority shall decide, after consultation with the
notifier, which information will be kept confidential and shall inform
the notifier of its decisions.
4. In no case may the following information when submitted according to
Articles 5 or 11 be kept confidential:
- description of the GMO or GMOs, name and address of the notifier,
purpose of the release and location of release;
- methods and plans for monitoring of the GMO or GMOs and for emergency
response;
- the evaluation of foreseeable effects, in particular any pathogenic
and/or ecologically disruptive effects.
5. If, for whatever reasons, the notifier withdraws the notification,
the competent authorities and the Commission must respect the
confidentiality of the information supplied.
Article 20
According to the procedure laid down in Article 21, the Commission shall
adapt Annexes II and III to technical progress in particular by amending
the notification requirements to take into account the potential hazard
of the GMOs.
Article 21
The Commission shall be assisted by a committee composed of the
representatives of the Member States and chaired by the representative
of the Commission.
The representative of the Commission shall submit to the committee a
draft of the measures to be taken. The committee shall deliver its
opinion on the draft within a time limit which the chairman may lay down
according to the urgency of the matter. The opinion shall be delivered
by the majority laid down in Article 148 (2) of the Treaty in the case
of decisions which the Council is required to adopt on a proposal from
the Commission. The votes of the representatives of the Member States
within the committee shall be weighted in the manner set out in that
Article. The chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in
accordance with the opinion of the committee.
If the measures envisaged are not in accordance with the opinion of the
committee, or if no opinion is delivered, the Commission shall, without
delay, submit to the Council a proposal relating to the measures to be
taken. The Council shall act by a qualified majority.
If, on the expiry of a period of three months from the date of referral
to the Council, the Council has not acted, the proposed measures shall
be adopted by the Commission.
Article 22
1. Member States and the Commission shall meet regularly and exchange
information on the experience acquired with regard to the prevention of
risks related to the release of GMOs into the environment.
2. Every three years, Member States shall send the Commission a report
on the measures taken to implement the provisions of this Directive, the
first time being on 1 September 1992.
3. Every three years, the Commission shall publish a summary based on
the reports referred to in paragraph 2, the first time being in 1993.
Article 23
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directive before
23 October 1991.
2. Member States shall immediately inform the Commission of all laws,
regulations and administrative provisions adopted in implementation of
this Directive.
Article 24
This Directive is addressed to the Member States.
COMMISSION IMPLEMENTING MEASURES
Decision
91/274/EEC - Official Journal L 135, 30.05.1991
Commission Decision of 21 May 1991 on a list of Community legislation
referred to in Article 10 of Directive 90/220/EEC.
Decision
92/146/EEC - Official Journal L 60, 05.03.1992
Commission Decision of 11 February 1992 concerning the summary
notification information format referred to in Article 12 of Directive
90/220/EEC.
Commission Decision of 18 December
1992 concerning the placing on the market of products containing GMOs
pursuant to Article 13 of Directive 90/220/EEC.
Decision
93/572/EEC - Official Journal L 276, 09.11.1993
Commission Decision of 19 October 1993 concerning the placing on the
market of products containing GMOs pursuant to Article 13 of Directive
90/220/EEC.
Decision
93/584/EEC - Offical Journal L 279, 12.11.1993
Commission Decision of 22 October 1993 establishing the criteria for
simplified procedures concerning the deliberate release into the
environment of genetically modified plants pursuant to Article 6(5) of
Council Directive 90/220/EEC.
This text applies only to genetically modified plants, which is the
group of GMOs with which most of the experience has been acquired to
date.
Directive
94/15/EC - Official Journal L 103, 22.04.1994
Commission Directive of 15 April 1994 adapting to technical progress for
the first time Council Directive 90/220/EEC on the deliberate release
into the environment of genetically modified organisms.
Decision
94/211/EC - Official Journal L 105, 26.04.1994
Commission Decision of 15 April 1994 amending Council Decision
91/596/EEC concerning the summary notification information format
referred to in Article 9 of Council Directive 90/220/EEC.
This decision replaces the annex to Decision 91/596/EEC.
Decision
94/730/EC - Official Journal L 292, 12.11.1994
Commission Decision of 4 November 1994 establishing simplified
procedures concerning the deliberate release into the environment of
genetically modified plants pursuant to Article 6 (5) of Council
Directive 90/220/EEC.
Decision
96/158/EC - Official Journal L 37, 15.02.1996
Commission Decision of 6 February 1996 concerning the placing on the
market of a product consisting of a genetically modified organism,
hybrid herbicide-tolerant swede-rape seeds (Brassica napus L. oleifera
Metzq. MS1Bn × RF1Bn), pursuant to Council Directive 90/220/EEC.
Decision
96/281/EC - Official Journal L 107, 30.04.1996.
Commission Decision of 3 April 1996 concerning the placing on the
market of genetically modified soya beans (Glycine max L.) with
increased tolerance to the herbicide glyphosate, pursuant to Council
Directive 90/220/EEC. This Decision authorizes the United Kingdom to
place on the market a product consisting of soya beans derived from the
soya bean “Glycine max L cv A 5403”.
Decision
96/424/EC - Official Journal L 175, 13.07.1996
Commission Decision of 20 May 1996 concerning the placing on the market
of genetically modified male sterile chicory (Cichorium intybus L.) with
partial tolerance to the herbicide glufosinate ammonium pursuant to
Council Directive 90/220/EEC.
Decision
97/392/EC -Official Journal L 164, 21.06.1997
Commission Decision of 6 June 1997 concerning the placing on the market
of genetically modified swede- rape (Brassica napus L. oleifera Metzg.
MS1, RF1), pursuant to Council Directive 90/220/EEC.
Decision
97/393/EC - Official Journal L 164, 21.06.1997
Commission Decision of 6 June 1997 concerning the placing on the market
of genetically modified swede- rape (Brassica napus L. oleifera Metzg.
MS1, RF2), pursuant to Council Directive 90/220/EEC.
Decision
97/549/EC - Official Journal L 225, 15.08.1997
Commission Decision of 14 July 1997 concerning the placing on the market
of T102-test (Streptococcus thermophilus T102) pursuant to Council
Directive 90/220/EEC.
Decision
98/291/EC - Official Journal L 131, 05.05.1998
Commission Decision of 22 April 1998 concerning the placing on the
market of genetically modified spring swede rape (Brassica napus L. ssp.
oleifera), pursuant to Council Directive 90/220/EEC.
Decision
98/292/EC - Official Journal L 131, 05.05.1998
Commission Decision of 22 April 1998 concerning the placing on the
market of genetically modified maize (Zea mays L. line Bt-11), pursuant
to Council Directive 90/220/EEC.
Decision
98/293/EC - Official Journal L 131, 05.05.1998
Commission Decision of 22 April 1998 concerning the placing on the
market of genetically modified maize (Zea mays L. T25), pursuant to
Council Directive 90/220/EEC.
Decision
98/294/EC - Official Journal L 131, 05.05.1998
Commission Decision of 22 April 1998 concerning the placing on the
market of genetically modified maize (Zea mays L. line MON 810),
pursuant to Council Directive 90/220/EEC.
397R0258
Regulation (EC) No 258/97 of the
European Parliament and of the Council of 27 January 1997 concerning
novel foods and novel food ingredients
Official
Journal L 043 , 14/02/1997 p. 0001 - 0007
Article 1
1. This Regulation concerns the placing on the market within the
Community of novel foods or novel food ingredients.
2. This Regulation shall apply to the placing on the market within the
Community of foods and food ingredients which have not hitherto been
used for human consumption to a significant degree within the Community
and which fall under the following categories:
(a) foods and food ingredients containing or consisting of genetically
modified organisms within the meaning of Directive 90/220/EEC;
(b) foods and food ingredients produced from, but not containing,
genetically modified organisms;
(c) foods and food ingredients with a new or intentionally modified
primary molecular structure;
(d) foods and food ingredients consisting of or isolated from
micro-organisms, fungi or algae;
(e) foods and food ingredients consisting of or isolated from plants and
food ingredients isolated from animals, except for foods and food
ingredients obtained by traditional propagating or breeding practices
and having a history of safe food use;
(f) foods and food ingredients to which has been applied a production
process not currently used, where that process gives rise to significant
changes in the composition or structure of the foods or food ingredients
which affect their nutritional value, metabolism or level of undesirable
substances.
3. Where necessary, it may be determined in accordance with the
procedure laid down in Article 13 whether a type of food or food
ingredient falls within the scope of paragraph 2 of this Article.
Article 2
1. This Regulation shall not apply to:
(a) food additives falling within the scope of Council Directive
89/107/EEC of 21 December 1988 on the approximation of the laws of the
Member States concerning food additives authorized for use in foodstuffs
intended for human consumption (12);
(b) flavourings for use in foodstuffs, falling within the scope of
Council Directive 88/388/EEC of 22 June 1988 on the approximation of the
laws of the Member States relating to flavourings for use in foodstuffs
and to source materials for their production (13);
(c) extraction solvents used in the production of foodstuffs, falling
within the scope of Council Directive 88/344/EEC of 13 June 1988 on the
approximation of the laws of the Member States on extraction solvents
used in the production of foodstuffs and food ingredients (14).
2. The exclusions from the scope of this Regulation referred to in
paragraph 1, indents (a) to (c) shall only apply for so long as the
safety levels laid down in Directives 89/107/EEC, 88/388/EEC and
88/344/EEC correspond to the safety level of this Regulation.
3. With due regard for Article 11 the Commission shall ensure that the
safety levels laid down in the above Directives, as well as in the
implementing measures for these Directives and this Regulation,
correspond to the safety level of this Regulation.
Article 3
1. Foods and food ingredients falling within the scope of this
Regulation must not:
- present a danger for the consumer,
- mislead the consumer,
- differ from foods or food ingredients which they are intended to
replace to such an extent that their normal consumption would be
nutritionally disadvantageous for the consumer.
2. For the purpose of placing the foods and food ingredients falling
within the scope of this Regulation on the market within the Community,
the procedures laid down in Articles 4, 6, 7 and 8 shall apply on the
basis of the criteria defined in paragraph 1 of this Article and the
other relevant factors referred to in those Articles.
However, in the case of foods or food ingredients referred to in this
Regulation derived from plant varieties subject to Directives 70/457/EEC
and 70/458/EEC, the authorization decision referred to in Article 7 of
this Regulation shall be taken in accordance with the procedures
provided for in those Directives, provided they take account of the
assessment principles laid down in this Regulation and the criteria set
out in paragraph 1 of this Article, with the exception of the provisions
relating to the labelling of such foods or food ingredients, which shall
be established, pursuant to Article 8, in accordance with the procedure
laid down in Article 13.
3. Paragraph 2 shall not apply to the foods and food ingredients
referred to in Article 1 (2) (b) where the genetically modified organism
used in the production of the food or food ingredient has been placed on
the market in accordance with this Regulation.
4. By way of derogation from paragraph 2, the procedure laid down in
Article 5 shall apply to foods or food ingredients referred to in
Article 1 (2) (b), (d) and (e) which, on the basis of the scientific
evidence available and generally recognized or on the basis of an
opinion delivered by one of the competent bodies referred to in Article
4 (3), are substantially equivalent to existing foods or food
ingredients as regards their composition, nutritional value, metabolism,
intended use and the level of undesirable substances contained therein.
Where necessary, it may be determined in accordance with the procedure
laid down in Article 13 whether a type of food or food ingredient falls
under this paragraph.
Article 4
1. The person responsible for placing on the Community market
(hereinafter ‘the applicant`) shall submit a request to the Member
State in which the product is to be placed on the market for the first
time. At the same time, he shall forward a copy of the request to the
Commission.
2. An initial assessment as provided for in Article 6 shall be carried
out.
Following the procedure referred to in Article 6 (4), the Member State
referred to in paragraph 1 shall inform the applicant without delay:
- that he may place the food or food ingredient on the market, where the
additional assessment referred to in Article 6 (3) is not required, and
that no reasoned objection has been presented in accordance with Article
6 (4), or
- that, in accordance with Article 7, an authorization decision is
required.
3. Each Member State shall notify to the Commission the name and address
of the food assessment bodies responsible in its territory for preparing
the initial assessment reports referred to in Article 6 (2).
4. Before the date of entry into force of this Regulation, the
Commission shall publish recommendations concerning the scientific
aspects of:
- the information necessary to support an application and the
presentation of such information,
- the preparation of the initial assessment reports provided for in
Article 6.
5. Any detailed rules for implementing this Article shall be adopted in
accordance with the procedure laid down in Article 13.
Article 5
In the case of the foods or food ingredients referred to in Article 3
(4), the applicant shall notify the Commission of the placing on the
market when he does so. Such notification shall be accompanied by the
relevant details provided for in Article 3 (4). The Commission shall
forward to Member States a copy of that notification within 60 days and,
at the request of a Member State, a copy of the said relevant details.
The Commission shall publish each year a summary of those notifications
in the ‘C` series of the Official Journal of the European Communities.
With respect to labelling, the provisions of Article 8 shall apply.
Article 6
1. The request referred to in Article 4 (1) shall contain the necessary
information, including a copy of the studies which have been carried out
and any other material which is available to demonstrate that the food
or food ingredient complies with the criteria laid down in Article 3
(1), as well as an appropriate proposal for the presentation and
labelling, in accordance with the requirements of Article 8, of the food
or food ingredient. In addition, the request shall be accompanied by a
summary of the dossier.
2. Upon receipt of the request, the Member State referred to in Article
4 (1) shall ensure that an initial assessment is carried out. To that
end, it shall notify the Commission of the name of the competent food
assessment body responsible for preparing the initial assessment report,
or ask the Commission to arrange with another Member State for one of
the competent food assessment bodies referred to in Article 4 (3) to
prepare such a report.
The Commission shall forward to the Member States without delay a copy
of the summary provided by the applicant and the name of the competent
body responsible for carrying out the initial assessment.
3. The initial assessment report shall be drawn up within a period of
three months from receipt of a request meeting the conditions laid down
in paragraph 1, in accordance with the recommendations referred to in
Article 4 (4), and shall decide whether or not the food or food
ingredient requires additional assessment in accordance with Article 7.
4. The Member State concerned shall without delay forward the report of
the competent food assessment body to the Commission, which shall
forward it to the other Member States. Within a period of 60 days from
the date of circulation of the report by the Commission, a Member State
or the Commission may make comments or present a reasoned objection to
the marketing of the food or food ingredient concerned. The comments or
objections may also concern the presentation or labelling of the food or
food ingredient.
Comments or objections shall be forwarded to the Commission, which shall
circulate them to Member States within the period of 60 days referred to
in the first subparagraph.
The applicant shall, where a Member State so requests, provide a copy of
any pertinent information appearing in the request.
Article 7
1. Where an additional assessment is required in accordance with Article
6 (3) or an objection is raised in accordance with Article 6 (4), an
authorization decision shall be taken in accordance with the procedure
laid down in Article 13.
2. The decision shall define the scope of the authorization and shall
establish, where appropriate:
- the conditions of use of the food or food ingredient,
- the designation of the food or food ingredient, and its specification,
- specific labelling requirements as referred to in Article 8.
3. The Commission shall without delay inform the applicant of the
decision taken. Decisions shall be published in the Official Journal of
the European Communities.
Article 8
1. Without prejudice to the other requirements of Community law
concerning the labelling of foodstuffs, the following additional
specific labelling requirements shall apply to foodstuffs in order to
ensure that the final consumer is informed of:
(a) any characteristic or food property such as:
- composition,
- nutritional value or nutritional effects,
- intended use of the food,
which renders a novel food or food ingredient no longer equivalent to an
existing food or food ingredient.
A novel food or food ingredient shall be deemed to be no longer
equivalent for the purpose of this Article if scientific assessment,
based upon an appropriate analysis of existing data, can demonstrate
that the characteristics assessed are different in comparison with a
conventional food or food ingredient, having regard to the accepted
limits of natural variations for such characteristics.
In this case, the labelling must indicate the characteristics or
properties modified, together with the method by which that
characteristic or property was obtained;
(b) the presence in the novel food or food ingredient of material which
is not present in an existing equivalent foodstuff and which may have
implications for the health of certain sections of the population;
(c) the presence in the novel food or food ingredient of material which
is not present in an existing equivalent foodstuff and which gives rise
to ethical concerns;
(d) the presence of an organism genetically modified by techniques of
genetic modification, the non-exhaustive list of which is laid down in
Annex I A, Part 1 of Directive 90/220/EEC.
2. In the absence of an existing equivalent food or food ingredient,
appropriate provisions shall be adopted where necessary in order to
ensure that consumers are adequately informed of the nature of the food
or food ingredient.
3. Any detailed rules for implementing this Article shall be adopted in
accordance with the procedure laid down in Article 13.
Article 9
1. Where a food or food ingredient falling within the scope of this
Regulation contains or consists of a genetically modified organism
within the meaning of Article 2 (1) and (2) of Directive 90/220/EEC, the
information required in the request for placing on the market referred
to in Article 6 (1) shall be accompanied by:
- a copy of the written consent, if any, from the competent authority,
to the deliberate release of the genetically modified organisms for
research and development purposes provided for in Article 6 (4) of
Directive 90/220/EEC, together with the results of the release(s) with
respect to any risk to human health and the environment;
- the complete technical dossier supplying the relevant information
requested in Article 11 of Directive 90/220/EEC and the environmental
risk assessment based on this information, the results of any studies
carried out for the purposes of research and development or, where
appropriate, the decision authorizing the placing on the market provided
for in part C of Directive 90/220/EEC.
Articles 11 to 18 of Directive 90/220/EEC shall not apply to foods or
food ingredients which contain or consist of genetically modified
organisms.
2. In the case of foods or food ingredients falling within the scope of
this Regulation containing or consisting of genetically modified
organisms, the decision referred to in Article 7 shall respect the
environmental safety requirements laid down by Directive 90/220/EEC to
ensure that all appropriate measures are taken to prevent the adverse
effects on human health and the environment which might arise from the
deliberate release of genetically modified organisms. During evaluation
of requests for the placing on the market of products containing or
consisting of genetically modified organisms, the necessary
consultations shall be held by the Commission or the Member States with
the bodies set up by the Community or the Member States in accordance
with Directive 90/220/EEC.
Article 10
Detailed rules for the protection of the information provided by the
applicant shall be adopted in accordance with the procedure laid down in
Article 13.
Article 11
The Scientific Committee for Food shall be consulted on any matter
falling within the scope of this Regulation likely to have an effect on
public health.
Article 12
1. Where a Member State, as a result of new information or a
reassessment of existing information, has detailed grounds for
considering that the use of a food or a food ingredient complying with
this Regulation endangers human health or the environment, that Member
State may either temporarily restrict or suspend the trade in and use of
the food or food ingredient in question in its territory. It shall
immediately inform the other Member States and the Commission thereof,
giving the grounds for its decision.
2. The Commission shall examine the grounds referred to in paragraph 1
as soon as possible within the Standing Committee for Foodstuffs; it
shall take the appropriate measures in accordance with the procedure
laid down in Article 13. The Member State which took the decision
referred to in paragraph 1 may maintain it until the measures have
entered into force.
Article 13
1. Where the procedure defined in this Article is to be implemented, the
Commission shall be assisted by the Standing Committee for Foodstuffs,
hereinafter referred to as the ‘Committee`.
2. Matters shall be referred to the Committee by the Chairman either on
his own initiative or at the request of the representative of a Member
State.
3. The representative of the Commission shall submit to the Committee a
draft of the measures to be taken. The Committee shall deliver its
opinion on the draft within a time limit which the Chairman may lay down
according to the urgency of the matter. The opinion shall be delivered
by the majority laid down in Article 148 (2) of the Treaty in the case
of decisions which the Council is required to adopt on a proposal from
the Commission. The votes of the representatives of the Member States
within the Committee shall be weighted in the manner set out in that
Article. The Chairman shall not vote.
4. (a) The Commission shall adopt the measures envisaged if they are in
accordance with the opinion of the Committee.
(b) If the measures envisaged are not in accordance with the opinion of
the Committee, or if no opinion is delivered, the Commission shall,
without delay, submit to the Council a proposal relating to the measures
to be taken. The Council shall act by a qualified majority.
If, on the expiry of a period of three months from the date of referral
to the Council, the Council has not acted, the proposed measures shall
be adopted by the Commission.
Article 14
1. No later than five years from the date of entry into force of this
Regulation and in the light of experience gained, the Commission shall
forward to the European Parliament and to the Council a report on the
implementation of this Regulation accompanied, where appropriate, by any
suitable proposal.
2. Notwithstanding the review provided for in paragraph 1, the
Commission shall monitor the application of this Regulation and its
impact on health, consumer protection, consumer information and the
functioning of the internal market and, if necessary, will bring forward
proposals at the earliest possible date.
Article 15
This Regulation shall enter into force 90 days following its publication
in the Official Journal of the European Communities.
COMMISSION STATEMENT - AD ARTICLE 2
The Commission confirms that should it appear, in the light of
experience, that there are gaps in the system of protection of public
health provided for by the existing legal framework, in particular in
respect of processing aids, it will formulate appropriate proposals in
order to fill those gaps.
398R1139
Council
Regulation (EC) No 1139/98 of 26 May 1998 concerning the compulsory
indication of the labelling of certain foodstuffs produced from
genetically modified organisms of particulars other than those provided
for in Directive 79/112/EEC
Official Journal L 159 ,
03/06/1998 p. 0004 - 0007
Amendments:
Amended by 300R0049
(OJ L 006 11.01.00 p.13)
Text:
COUNCIL REGULATION (EC) No 1139/98
of 26 May 1998 concerning the compulsory indication of the labelling of
certain foodstuffs produced from genetically modified organisms of
particulars other than those provided for in Directive 79/112/EEC
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 79/112/EEC of 18 December 1978 on the
approximation of the laws of the Member States relating to the labelling,
presentation and advertising of foodstuffs (1), and in particular
Article 4(2) thereof,
Having regard to the proposal from the Commission,
(1) Whereas, in accordance with the provisions of Part C of Council
Directive 90/220/EEC of 23 April 1990 on the deliberate release into the
environment of genetically modified organisms (2), consents have been
given for the placing on the market of certain genetically modified
products by Commission Decision 96/281/EC of 3 April 1996 concerning the
placing on the market of genetically modified soya beans (Glycine max
L.) with increased tolerance to the herbicide glyphosate, pursuant to
Council Directive 90/220/EEC (3), and by Commission Decision 97/98/EC of
23 January 1997 concerning the placing on the market of genetically
modified maize (Zea mays L.) with the combined modification for
insecticidal properties conferred by the Bt-endotoxin gene and increased
tolerance to the herbicide glufosinate ammonium pursuant to Council
Directive 90/220/EEC (4);
(2) Whereas in accordance with Directive 90/220/EEC there were no safety
grounds for mentioning on the label of genetically modified soya beans (Glycine
max L.) or of genetically modified maize (Zea mays L.) that they were
obtained by genetic modification techniques;
(3) Whereas Directive 90/220/EEC does not cover non-viable products
derived from genetically modified organisms (hereinafter referred to as
‘GMOs`);
(4) Whereas certain Member States have taken measures in respect of the
labelling of foods and food ingredients produced from the products
concerned; whereas differences between those measures are liable to
impede the free movement of those foods and food ingredients and thereby
adversely affect the functioning of the internal market; whereas it is
therefore necessary to adopt uniform Community labelling rules for the
products concerned;
(5) Whereas Regulation (EC) No 258/97 of the European Parliament and of
the Council of 27 January 1997 concerning novel foods and novel food
ingredients (5), lays down, in Article 8, additional specific labelling
requirements in order to ensure proper information for the final
consumer; whereas those additional specific labelling requirements do
not apply to foods or food ingredients which were used for human
consumption to a significant degree within the Community before the
entry into force of Regulation (EC) 258/97 and are for that reason
considered not to be novel;
(6) Whereas, in order to prevent distortions of competition, labelling
rules for the information of the final consumer based on the same
principles should apply to foods and food ingredients consisting of or
derived from GMOs which were placed on the market before the entry into
force of Regulation (EC) No 258/97 pursuant to a consent given under
Directive 90/220/EEC, and to foods and food ingredients which are placed
on the market thereafter;
(7) Whereas, therefore, Commission Regulation (EC) No 1813/97 of 19
September 1997 concerning the compulsory indication on the labelling of
certain foodstuffs produced from genetically modified organisms of
particulars other than those provided for in Directive 79/112/EEC (6)
laid down general labelling rules for the abovementioned products;
(8) Whereas it is now urgent to lay down detailed uniform Community
rules for the labelling of the foodstuffs covered by Regulation (EC) No
1813/97;
(9) Whereas, in particular, drawing on the approach taken in Article 8
of Regulation (EC) No 258/97, it is necessary to ensure that the final
consumer is informed of any characteristic or food property, such as
composition, nutritional value or nutritional effects or the intended
use of the food, which renders a food or food ingredient no longer
equivalent to an existing food or food ingredient; whereas, for that
purpose, foods and food ingredients produced from genetically modified
soya beans or from genetically modified maize which are not equivalent
to conventional counterparts should be subject to labelling
requirements;
(10) Whereas, drawing on the approach taken in Article 8 of Regulation
(EC) No 258/97, it is necessary that labelling requirements are based on
scientific evaluation;
(11) Whereas it is necessary to establish clear labelling rules for the
abovementioned products, allowing official control on a reliable,
readily repeatable and practicable basis; whereas common scientifically
validated testing methods should be developed;
(12) Whereas it is also necessary to ensure that the labelling
requirements are no more burdensome than necessary but sufficiently
detailed to supply consumers with the information they require;
(13) Whereas at this stage the presence in foods and food ingredients of
protein or DNA resulting from genetic modification constitutes the
criterion best complying with the abovementioned requirements; whereas
such an approach could be reconsidered in the light of future
developments in scientific knowledge;
(14) Whereas adventitious contamination of foodstuffs with DNA or
protein resulting from genetic modification cannot be excluded; whereas
labelling as a result of such contamination could be avoided by setting
a threshold for the detection of DNA and protein;
(15) Whereas urgent consideration must be given, in the light of any
relevant scientific advice, to the question of whether a de minimis
threshold for the presence of DNA or protein resulting from genetic
modification can be set and, if so, at what level;
(16) Whereas foods and food ingredients produced from genetically
modified soya beans (Glycine max L.) or from genetically modified maize
(Zea mays L.), in which DNA resulting from genetic modification is
present, are not equivalent and should therefore be subject to labelling
requirements;
(17) Whereas it is possible that protein or DNA resulting from genetic
modification has been destroyed by successive stages of processing;
whereas, in that case, foods and food ingredients should be considered
equivalent for labelling purposes; whereas they should therefore not be
subject to labelling requirements; whereas a list of such products
should be drawn up;
(18) Whereas, nevertheless, some processing methods may eliminate DNA
but not proteins; whereas the possibility cannot be excluded that such
methods may be capable of being applied to food uses; whereas foods and
food ingredients in which DNA resulting from genetic modification is not
present but in which proteins resulting from genetic modification are
present, cannot be considered to be equivalent; whereas therefore, they
should be subject to labelling requirements;
(19) Whereas the necessary information should be provided in the list of
ingredients except in the case of products for which no such list
exists, in which case it should appear clearly on the labelling of the
product;
(20) Whereas this Regulation is without prejudice to the operators’
right to include voluntary claims in the labels of their products as to
particulars other than those laid down in this Regulation (such as the
absence of foods and food ingredients produced from genetically modified
soya beans and maize, or the presence of such foods and food ingredients
in cases where it is not scientifically verifiable but evidence of it is
available through other means), provided that such claims are made in
compliance with the provisions of Directive 79/112/EEC;
(21) Whereas, having regard to their scope and effects, the Community
measures introduced by this Regulation are not only necessary but
essential if the objectives set are to be attained; whereas those
objectives cannot be attained by the Member States acting individually;
(22) Whereas this Regulation replaces Commission Regulation (EC) No
1813/97, which should therefore be repealed;
(23) Whereas in pursuance of the procedure laid down in Article 17 of
Directive 79/112/EEC, a draft of this text was submitted to the Standing
Committee on Foodstuffs, which was unable to deliver an opinion, and
whereas in accordance with the same procedure the Commission addressed a
proposal to the Council, concerning the measures to be adopted,
HAS ADOPTED THIS REGULATION:
Article 1
1. This Regulation shall apply to foods and food ingredients which are
to be delivered as such to the final consumer (hereinafter referred to
as ‘the specified foodstuffs`) produced, in whole or in part, from:
- genetically modified soya beans covered by Decision 96/281/EC,
- genetically modified maize covered by Decision 97/98/EC.
2. This Regulation shall not apply to food additives, flavourings for
use in foodstuffs or extraction solvents used in the production of
foodstuffs as referred to in Article 2(1) of Regulation (EC) No 258/97.
Article 2
1. The specified foodstuffs shall be subject to the additional specific
labelling requirements laid down in paragraph 3.
2. However, the specified foodstuffs in which neither protein nor DNA
resulting from genetic modification is present shall not be subject to
the said additional specific labelling requirements.
A list of products not subject to the additional specific labelling
requirements shall be drawn up under the procedure laid down in Article
17 of Directive 79/112/EEC, taking account of technical developments,
the opinion of the Scientific Committee on Food and any other relevant
scientific advice.
3. The additional specific labelling requirements shall be the
following:
(a) where the food consists of more than one ingredient, the words
‘produced from genetically modified soya` or ‘produced from
genetically modified maize`, as appropriate, shall appear in the list of
ingredients provided for by Article 6 of Directive 79/112/EEC in
parentheses immediately after the name of the ingredient concerned.
Alternatively, these words may appear in a prominently displayed
footnote to the list of ingredients, related by means of an asterisk (*)
to the ingredient concerned. Where an ingredient is already listed as
being produced from soya or maize the words ‘produced from genetically
modified` may be abbreviated to ‘genetically modified`; if the
abbreviated form of words is used as a footnote, the asterisk shall be
directly attached to the word ‘soya` or ‘maize`. Where either form
of words is used as a footnote, it shall have a typeface of at least the
same size as the list of ingredients itself;
(b) in the case of products for which no list of ingredients exists, the
words ‘produced from genetically modified soya` or ‘produced from
genetically modified maize`, as appropriate, shall appear clearly on the
labelling of the food;
(c) where in accordance with the provisions of the first indent of
Article 6(5)(b) of Directive 79/112/EEC an ingredient is designated by
the name of a category, that designation shall be completed by the words
‘contains . . . (*) produced from genetically modified soya/genetically
modified maize
(*) Ingredient(s) to be specified.`, as appropriate;
(d) where an ingredient of a compound ingredient is derived from the
specified foodstuffs, it shall be mentioned on the labelling of the
final product, with the addition of the wording set out in point (b).
4. This Article shall be without prejudice to the other requirements of
Community law concerning the labelling of foodstuffs.
Article 3
Commission Regulation (EC) No 1813/97 is hereby repealed.
Article 4
1. The labelling requirements of this Regulation shall not apply to
products which have been lawfully manufactured and labelled in the
Community, or which have been lawfully imported into the Community and
put into free circulation, before the entry into force of this
Regulation.
2. The application of Article 2 to products placed on the market with
labelling complying with Commission Regulation (EC) No 1813/97 so as to
indicate the presence of genetically modified material may be postponed
until six months after the entry into force of this Regulation.
Article 5
This Regulation shall enter into force 90 days after its publication in
the Official Journal of the European Communities.
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