natgillin/translations-raw huggingface dataset:
Når videnskabelige og teknologiske fremskridt gør det muligt, bør der fastsættes passende lavere tærskelværdier.
As and when advances in science and technology allow, appropriately lower thresholds should be established.
Der bør fastlægges systemer for udvikling og tildeling af entydige koder for GMO'er, inden foranstaltningerne vedrørende sporbarhed og mærkning anvendes.
Systems for the development and assignment of unique codes for GMOs should be established before the measures relating to traceability and labelling can be applied.
I denne forordning overholdes de grundlæggende rettigheder og de principper, som bl.a. Den Europæiske Unions charter om grundlæggende rettigheder anerkender -
This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union,
UDSTEDT FØLGENDE FORORDNING: Artikel 1 Formål
HAVE ADOPTED THIS REGULATION: Article 1 Subject matter
Denne forordning fastsætter rammebestemmelser for sporbarhed af genetisk modificerede organismer (GMO'er) og
This Regulation provides a framework for the traceability of genetically modified organisms (GMOs), and food and feed produced from GMOs, with the objective of
at beskytte menneskers og dyrs sundhed
protecting human and animal health,
at beskytte miljøet og økosystemer
protecting the environment and ecosystems,
at sikre, at det indre marked fungerer godt, og i den forbindelse fastholde målsætningen om at give høj prioritet til menneskers sundhed og miljøet og til forbrugernes ret til at få den nødvendige information, således at de kan træffe et frit og selvstændigt valg, samt at føre kontrol med produkterne gennem sporing og mærkning
ensuring the smooth operation of the internal market, while recognising the priority which must be accorded to human health and the environment and to the right of the consumer to be given the necessary information to make a free and independent choice, and monitoring the products by means of tracing and labelling,
at sikre forbrugernes ret til at træffe et frit og selvstændigt valg
giving consumers the right of free and independent choice,
at muliggøre indførelse af effektive foranstaltninger til hindring af utilsigtet tilstedeværelse af GMO'er eller produkter heraf i andre fødevarer eller foderstoffer og
allowing effective measures to be introduced to prevent the unintended presence of GMOs or products thereof in other food or feed, and
at gennemføre øjeblikkelig, hurtig og total tilbagetrækning, hvis disse produkter viser sig at være skadelige eller farlige.
enabling such products to be withdrawn immediately, rapidly and totally in the event that they should prove harmful or hazardous.
Denne forordning finder anvendelse på alle stadier i markedsføringen af:
This Regulation shall apply, at all stages of the placing on the market, to:
produkter, der består af eller som indeholder GMO'er, og som er markedsført i overensstemmelse med fællesskabslovgivningen
products consisting of, or containing GMOs, placed on the market in accordance with Community legislation;
fødevarer og fødevareingredienser herunder fødevaretilsætningsstoffer og -aromaer, der er fremstillet af GMO'er, og som er markedsført i overensstemmelse med fællesskabslovgivningen
foods and food ingredients, including food additives and flavourings, produced from GMOs, placed on the market in accordance with Community legislation;
fodermidler, foderblandinger og tilsætningsstoffer til foder, der er fremstillet af GMO'er, og som er markedsført i overensstemmelse med fællesskabslovgivningen.
feed materials, compound feedingstuffs and feed additives, produced from GMOs, placed on the market in accordance with Community legislation.
I denne forordning:
For the purpose of this Regulation:
defineres "genetisk modificeret organisme" (
'genetically modified organism'
som i artikel 2, stk. 2, i direktiv 2001/18/EF
means genetically modified organism as defined in Article 2(2) of Directive 2001/18/EC
forstås ved "fremstillet af GMO'er": helt eller delvis afledt af
'produced from GMOs' means derived, in whole or in part, from
forstås ved "sporbarhed": muligheden for at spore GMO'er og produkter fremstillet af GMO'er på alle stadier i markedsføringen heraf gennem produktions- og distributionskæden
"traceability' means the ability to trace GMOs and products produced from GMOs at all stages of their placing on the market through the production and distribution chains;
forstås ved "entydig kode": en simpel numerisk eller alfanumerisk kode, som tjener til at identificere en GMO på grundlag af den godkendte transformationsbegivenhed, ud fra hvilken GMO'en er udviklet, og som giver mulighed for at indhente specifikke oplysninger vedrørende den pågældende GMO
'unique code' means a simple numeric or alphanumeric code which serves to identify a GMO on the basis of the authorised transformation event from which it was developed and providing the means to retrieve specific information pertinent to that GMO;
forstås ved "virksomhed": en person, som markedsfører et produkt, og også en person, der i et hvilket som helst led i produktions- og distributionskæden modtager et produkt
'operator' means a person who places a product on the market and also a person who receives a product that has been placed on the market in the Community
fra en EU-medlemsstat eller fra et tredjeland
, either from a Member State of the EU or from a third country,
, som er markedsført i Fællesskabet, men ikke den endelige forbruger
at any stage of the production and distribution chain, but does not include the ultimate consumer;
forstås ved "fødevarer": fødevarer som defineret i artikel 2
'food' means food as defined in Article 2 of
i Europa-Parlamentets og Rådets forordning (EF) nr. 178/2002
European Parliament and Council Regulation (EC) No 178/2002
defineres "aroma" som i artikel 1, stk. 2, i Rådets direktiv 88/388/EØF EFT L 184 af 15.7.1988, s. 61.
'flavouring' means flavouring as defined in Article 1(2) of Council Directive 88/388/EEC OJL 184, 15.7.1988, p.
defineres "foder" eller "foderstoffer" som i artikel 3,
'feed' or 'feedingstuff' means feed or feedingstuff as defined in Article 3(4)
stk. 4, i forordning (EF) nr. 178/2002
of Regulation (EC) No 178/2002;
forstås ved "foderblandinger": produkter som defineret i artikel 2, litra b), i Rådets direktiv 79/373/EØF EFT L 86 af 6.4.1979, s. 30.
'compound feedingstuffs' means compound feedingstuffs as defined in Article 2(b) of Council Directive 79/373/EEC OJ L 86, 6.4.1979, p.
forstås ved "fodermidler": produkter som defineret i artikel 2, litra a), i Rådets direktiv 96/25/EF EFT L 125 af 23.5.1996, s. 35
'feed materials' means feed materials as defined in Article 2(a) of Council Directive 96/25/EC OJ L 125, 23.5.1996, p.
forstås ved "markedsføring": stillen til rådighed for tredjemand, mod eller uden vederlag
"placing on the market' means making available to third parties, whether in return for payment or free of charge;
Det betragtes ikke som markedsføring, at genetisk modificerede mikro-organismer stilles til rådighed for aktiviteter reguleret i Rådets direktiv 90/219/EØF
Making available genetically modified micro-organisms for activities regulated under Council Directive 90/219/EEC
, herunder afgrødesamlinger.
, including culture collections, shall not be regarded as placing on the market;
forstås ved "det første stadium i markedsføringen af et produkt": den første transaktion i produktions- og distributionskæden, hvor et produkt stilles til rådighed for tredjemand
'the first stage of the placing on the market of a product' means the initial transaction in the production and distribution chains, where a product is made available to a third party;
forstås ved "færdigpakket produkt": en vare, der udbydes til
'pre-packaged' means any single item for
af et produkt og den emballage, produktet blev pakket i, inden det blev udbudt til salg, uanset om emballagen omslutter produktet helt eller kun delvis, men forudsat at indholdet ikke kan ændres, uden at emballagen åbnes eller ændres.
of a product and the packaging into which it was put before being offered for sale, whether such packaging encloses the product completely or only partially, but in such a way that the contents cannot be altered without opening or changing the packaging.
Artikel 4 Krav til sporbarhed og mærkning af GMO'er
Article 4 Traceability and labelling requirements for GMOs
Ved markedsføring af færdigpakkede produkter, der består af eller indeholder GMO'er, sikrer virksomhederne, at ordene "Dette produkt indeholder genetisk modificerede organismer"
When placing pre-packaged products consisting of, or containing, GMOs on the market, operators shall ensure that the words 'This product contains genetically modified organisms'
eller "Dette produkt indeholder genetisk modificeret (eller GM) ... [navn på afgrøde eller GMO]"
or 'This product contains genetically modified (or GM) ... (name of crop or GMO)'
optræder på mærkningen.
appear on the label.
at det indeholder eller består af GMO'er
that it contains or consists of GMOs;
de entydige
the unique
koder, der er tildelt de pågældende GMO'er i overensstemmelse med
code(s) assigned to those GMOs in accordance with
alle efterfølgende stadier i markedsføringen af de i stk. 2 omhandlede produkter sikrer virksomhederne, at de oplysninger, de har modtaget i overensstemmelse med stk. 2, videregives til de virksomheder, der modtager produkterne.
all subsequent stages of the placing on the market of products referred to in paragraph 2, operators shall ensure that the information received in accordance with paragraph 2 is transmitted to the operators receiving the products.
Uden at dette berører artikel 6, indfører virksomhederne systemer og
Without prejudice to Article 6, operators shall have in place systems and
, der i et tidsrum på
procedures to allow the identification, for a period of
efter hver transaktion gør det muligt at fastslå, fra hvem og til hvem de i stk. 2 omhandlede produkter er stillet til rådighed.
years from each transaction, of the person from whom and to whom the products referred to in paragraph 2 have been made available.
Artikel 5 Særlige krav for produkter fremstillet af GMO'er
Article 5 Traceability requirements for products produced from GMOs
angivelse af hver af de fødevareingredienser, herunder tilsætningsstoffer og aromaer, som er fremstillet af GMO'er
an indication of each of the food ingredients, including additives and flavouring(s), which is produced from GMOs;
angivelse af hvert af de fodermidler eller tilsætningsstoffer til foderstoffer, som er fremstillet af GMO'er
an indication of each of the feed materials or additives which is produced from GMOs;
for produkter, for hvilke der ikke findes nogen ingrediensliste: angivelse af, at produktet er fremstillet af GMO'er.
in the case of products for which no list of ingredients exists, an indication that the product is produced from GMOs.
berører ikke andre særlige krav i fællesskabslovgivningen.
are without prejudice to other specific requirements in Community legislation.
Artikel 6 Undtagelser
Article 6 Exemptions
I tilfælde, hvor fællesskabslovgivningen indeholder bestemmelser om særlige identifikationssystemer, som f.eks. parti- eller batchnummerering af færdigpakkede produkter, er
In cases where Community legislation provides for specific identification systems, such as lot or batch numbering for pre-packaged products, operators
de virksomheder, der modtager det færdigpakkede produkt,
who receive the pre-packaged product shall be
Uanset artikel 4, stk. 3 og 4, og artikel 5,
By way of derogation from Articles 4(3), 4 (4) and 5(
, er virksomheder, som leverer fødevarer til den endelige forbruger, ikke forpligtet til at opbevare dokumentation for, hvem produkterne er solgt til.
), operators delivering food to the ultimate consumer shall not be obliged to retain documentation detailing to whom products were sold.
som indeholder spor af stoffer fremstillet af GMO'er, er
which contain traces of materials produced from GMOs shall
ikke omfattet af bestemmelserne i
be exempt from the requirements of
Artikel 8
8 Unique codes
om nødvendigt tilpasse det i litra a) nævnte system under hensyntagen til den yderligere udvikling i de internationale fora.
adapt the system provided for in point (a), as appropriate, taking into account further developments in international fora.
Artikel 9 Tilsyns- og kontrolforanstaltninger
Article 9 Inspection and control measures
Medlemsstaterne sørger for, at
Member States shall ensure that inspections,
tilsyn samt risikovurdering på grundlag af stikprøvekontrol og (kvantitativ og kvalitativ) afprøvning
risk assessment on the basis of sample checks and testing (quantitative and qualitative)
og andre kontrolforanstaltninger gennemføres i nødvendigt omfang til sikring af, at denne forordning efterkommes.
and other control measures, as appropriate, are carried out to ensure compliance with this Regulation.
finder anvendelse
, the Commission shall
Kommissionen tager under udarbejdelsen af de tekniske retningslinjer hensyn til det arbejde, der udføres af den komité, der er omhandlet af artikel 58, stk. 1, i forordning (EF) nr. 178/2002, samt bestemmelser om oprettelse af det fællesskabslaboratorium, der er fastsat i forordning (EF) nr. .../2002 [om genetisk modificerede levnedsmidler og foderstoffer].
In developing the above technical guidance, the Commission shall take account of the work of the committee referred to in Article 58(1) of Regulation (EC) No 178/2002 and of the rules of the Community reference laboratory laid down pursuant to Regulation (EC) No .../2002 [on genetically modified food and feed].
Artikel 10 Udvalg
Article 10 Committee
Kommissionen bistås af
The Commission shall be assisted by the committee
Når der henvises til dette stykke anvendes forskriftsproceduren i artikel 5 i afgørelse 1999/468/EF, jf. dennes artikel 7 og 8.
Where reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Articles 7 and 8 thereof.
Medlemsstaterne meddeler disse bestemmelser til Kommissionen senest ...
Member States shall notify those provisions to the Commission, by ....
180 dage efter datoen for offentliggørelsen af denne forordning i De Europæiske Fællesskabers Tidende.
180 days following the date of publication of this Regulation in the Official Journal of the European Communities.
Artikel 12 Ikrafttræden
Article 12 Entry into force
Artikel 1-6
Articles 1 to
og skal være i overensstemmelse med direktiv 2001/18/EF.
and must be consistent with Directive 2001/18/EC.
European Parliament legislative resolution on the proposal for a European Parliament and Council regulation on genetically modified food and feed ( COM(2001) 425 – C5-0368/2001 – 2001/0173(COD))
European Parliament legislative resolution on the proposal for a European Parliament and Council regulation on genetically modified food and feed ( COM(2001) 425 – C5-0368/2001 – 2001/0173(COD))
(Codecision procedure: first reading)
(Codecision procedure: first reading)
having regard to Article 251(2) and Articles 37, 95 and 152(4) of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C5-0368/2001 )
having regard to Article 251(2) and Articles 37, 95 and 152(4) of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C5-0368/2001 )
having regard to Rule 67 of its Rules of Procedure,
having regard to Rule 67 of its Rules of Procedure,
having regard to the report of the Committee on the Environment, Public Health and Consumer Policy
having regard to the report of the Committee on the Environment, Public Health and Consumer Policy
and the opinions of the Committee on Legal Affairs and the Internal Market
and the opinions of the Committee on Legal Affairs and the Internal Market
and the Committee on Agriculture and Rural Development ( A5-0225/2002 ),
and the Committee on Agriculture and Rural Development ( A5-0225/2002 ),
Approves the Commission proposal as amended;
Approves the Commission proposal as amended;
Asks to be consulted again should the Commission intend to amend the proposal substantially or replace it with another text;
Asks to be consulted again should the Commission intend to amend the proposal substantially or replace it with another text;
Having regard to the Treaty establishing the European Community, and in particular Articles 37, 95 and 152 (4) (b) thereof,
Having regard to the Treaty establishing the European Community, and in particular Articles 37, 95 and 152 (4) (b) thereof,
Having regard to the proposal from the Commission OJ C
Having regard to the proposal from the Commission OJ C
Having regard to the opinion of the Economic and Social Committee OJ C
Having regard to the opinion of the Economic and Social Committee OJ C
Having regard to the opinion of the Committee of the Regions OJ C
Having regard to the opinion of the Committee of the Regions OJ C
Position of the European Parliament of 3 July 2002.
Position of the European Parliament of 3 July 2002.
The free movement of safe and wholesome food and feed is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.
The free movement of safe and wholesome food and feed is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.
A high level of protection of human life and health should be
A high level of protection of human life and health should be
in the pursuit of Community policies.
in the pursuit of Community policies.
Account must be taken of the precautionary principle in implementing this Regulation.
Account must be taken of the precautionary principle in implementing this Regulation.
In exceptional cases, where there is a risk to health or the environment, but where scientific data is as yet uncertain, the precautionary principle may be used to decide which risk management measures or other steps will be taken to ensure the high level of health protection that the Community desires.
In exceptional cases, where there is a risk to health or the environment, but where scientific data is as yet uncertain, the precautionary principle may be used to decide which risk management measures or other steps will be taken to ensure the high level of health protection that the Community desires.
In order to protect human and animal health, food and feed consisting of, containing or produced from genetically modified organisms (hereunder called "genetically modified food and feed") should undergo a safety assessment through a Community procedure before being placed on the market within the Community.
In order to protect human and animal health, food and feed consisting of, containing or produced from genetically modified organisms (hereunder called "genetically modified food and feed") should undergo a safety assessment through a Community procedure before being placed on the market within the Community.
Differences between national laws, regulations and administrative provisions concerning the assessment and authorisation of genetically modified food and feed may hinder their free movement, creating conditions of unequal and unfair competition.
Differences between national laws, regulations and administrative provisions concerning the assessment and authorisation of genetically modified food and feed may hinder their free movement, creating conditions of unequal and unfair competition.
The requirements arising from the directives, regulations and administrative provisions concerning the evaluation and authorisation of food and feed and of raw materials intended for their production should be identical for all products imported into the European Union, in order to avoid the creation of unequal and unfair conditions of competition.
The requirements arising from the directives, regulations and administrative provisions concerning the evaluation and authorisation of food and feed and of raw materials intended for their production should be identical for all products imported into the European Union, in order to avoid the creation of unequal and unfair conditions of competition.
An authorisation procedure involving Member States and the Commission has been established for genetically modified foods in
An authorisation procedure involving Member States and the Commission has been established for genetically modified foods in
European Parliament and Council
European Parliament and Council
Regulation (EC) No 258/97
Regulation (EC) No 258/97
of 27 January 1997
of 27 January 1997
This procedure should be streamlined and made more transparent.
This procedure should be streamlined and made more transparent.
Regulation (EC) No 258/97 also provides for a notification procedure for novel foods which are substantially equivalent to existing foods.
Regulation (EC) No 258/97 also provides for a notification procedure for novel foods which are substantially equivalent to existing foods.
Whilst substantial equivalence is a key step in the safety assessment process of genetically modified foods, it is not a safety assessment in itself.
Whilst substantial equivalence is a key step in the safety assessment process of genetically modified foods, it is not a safety assessment in itself.
In order to ensure clarity, transparency and a harmonised framework for authorisation of genetically modified food, this notification procedure should be abandoned in respect of genetically modified foods.
In order to ensure clarity, transparency and a harmonised framework for authorisation of genetically modified food, this notification procedure should be abandoned in respect of genetically modified foods.
Feed consisting of or containing genetically modified organisms (GMOs)
Feed consisting of or containing genetically modified organisms (GMOs)
so far been authorised in accordance with
so far been authorised in accordance with
Directive 90/220/EEC
Directive 90/220/EEC
of 23 April 1990
of 23 April 1990
; no authorisation procedure exists for feed produced from GMOs; a single, efficient and transparent Community authorisation procedure for feed consisting of, containing or produced from GMOs should be established.
; no authorisation procedure exists for feed produced from GMOs; a single, efficient and transparent Community authorisation procedure for feed consisting of, containing or produced from GMOs should be established.
The new authorisation procedures for genetically modified food and feed should include the new principles introduced in
The new authorisation procedures for genetically modified food and feed should include the new principles introduced in
Directive 2001/18/EC
Directive 2001/18/EC
of 12 March 2001
of 12 March 2001
They should further make use of the new framework for risk assessment in matters of food safety set up by
They should further make use of the new framework for risk assessment in matters of food safety set up by
178/2002 of 28 January 2002
178/2002 of 28 January 2002
laying down the general principles and requirements of food law, establishing the European Food
laying down the general principles and requirements of food law, establishing the European Food
Authority, and laying down procedures in matters of food safety OJ L
Authority, and laying down procedures in matters of food safety OJ L
Thus, genetically modified food and feed should only be authorised for placing on the Community market after a scientific evaluation of the highest possible standard, to be undertaken under the responsibility of the European Food
Thus, genetically modified food and feed should only be authorised for placing on the Community market after a scientific evaluation of the highest possible standard, to be undertaken under the responsibility of the European Food
Authority, of any risks which they present for human and animal health and, as the case may be, for the environment.
Authority, of any risks which they present for human and animal health and, as the case may be, for the environment.