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Royal Decree 1111 / 1991, Of 12 July, Amending The Reglamentación Of Food Additives, Approved By Royal Decree 3177/1983, Of 16 November, And Amended By Royal Decree 1339 / 1988, Of 28 October.

Original Language Title: Real Decreto 1111/1991, de 12 de julio, por el que se modifica la Reglamentación Técnico-Sanitaria de aditivos alimentarios, aprobada por Real Decreto 3177/1983, de 16 de noviembre, y modificada por Real Decreto 1339/1988, de 28 de octubre.

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TEXT

The adoption by the Council of the European Communities of Directive 89 /107/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to food additives authorised in the foodstuffs intended for human consumption (Official Journal of the European Communities No L 40 of 11 February 1989) obliges Spain as a Member State to carry out its transposition into national law by virtue of the provisions of the Article 12 of the same.

This Royal Decree is dictated by the provisions of Article 149.1.16.a of the Spanish Constitution and of the jurisdiction attributed to the State by Article 40.4 of Law 14/1986, of 25 April, General of Health.

In its virtue, on a proposal from the Ministers for Economic Affairs and Finance, Industry Trade and Tourism, Agriculture, Fisheries and Food and Health and Consumer Affairs, the sectors concerned, issued the Commission's mandatory report Interministerial for Food Management, in agreement with the Council of State and, after deliberation by the Council of Ministers, at its meeting on 12 July 1991,

D I S P O N G O:

Single item.

Articles 1, 2, 3, 3 and 8 are amended and Annex 3 is added to the technical-health regulation of food additives approved by Royal Decree 3177/1983 of 16 November 1983 (Official State Gazette of 28 September 1983). (December), and amended by Decree 1339/1988 of 28 October (Official Gazette of the State of November). The articles to be amended and the annexed annexed thereto shall be drawn up in the following terms

" Article 1. Application Scope.

This Regulation shall apply to the food additives listed in the categories set out in Article 3. which are used or intended to be used as components in the manufacture or preparation of foodstuffs and which continue to be present in the products produced, possibly in an amended form, hereinafter referred to as 'food additives'.

This regulation obliges those natural or legal persons who engage in the manufacture, manufacture, handling, circulation, marketing or import of the products defined in Article

.

This regulation will not apply to:

-Technological interveners, being understood as such to any substance that is not consumed as a food ingredient itself, that is intentionally used in the processing of raw materials, of food products or its ingredients, in order to meet a particular technological objective during the processing or processing, and which may result in the unintended but technically unavoidable presence of residues of that substance or its derivatives in the finished product, provided that such residues do not present a health risk and have no technological effects on the finished product.

-The substances used for the protection of plants and plant products in accordance with the technical-sanitary regulations for the manufacture, marketing and use of pesticides, approved by Royal Decree 3349/1983, of 30 November (Official Gazette of the State of 24 January 1984) and other provisions implementing it.

-The flavourings intended for use in foodstuffs and regulated by Royal Decree 1477/1990 of 2 November 1990 (Official Journal of the State of 22) approving the technical and health regulations of the the flavourings used in the food products and the basic materials for their production.

-Substances added to food products as nutritional products (such as minerals, trace elements, or vitamins). "

" Article 2. Definition and general criteria.

2.1 For the purposes of this Regulation, 'food additive' means any substance which is normally not consumed as a food in itself, nor is used as a characteristic ingredient in food, independently whether or not it has nutritional value, and whose intended addition to foodstuffs, for a technological purpose at the stage of its manufacture, processing, preparation, processing, packaging, transport or storage, or may be expected reasonably to have, directly or indirectly, as a result of the additive or its by-products are converted into a component of such foodstuffs.

Only those included in the positive lists approved by the Ministry of Health and Consumption may be used and shall be subject to the maximum conditions and doses laid down in those positive lists.

2.2 For the inclusion of an "additive" in the above "positive lists" it is essential that the product is adapted to the general criteria for the use of additives, as set out in Annex 3.

2.3 If, as a result of new information or the review of existing information on authorised additives, there are specific grounds for considering that the use of an additive in foodstuffs, The Ministry of Health and Consumer Affairs may temporarily suspend or restrict the authorisation of such an additive. The other Member States and the Commission of the European Communities shall be informed immediately, indicating the reasons for their decision.

2.4 In order to adapt to scientific or technical developments, the Ministry of Health and Consumer Affairs may authorise on a provisional basis the trade and use of additives not included in the specific lists of the categories listed in the Annex. Article 3. of this Regulation, provided that the following conditions are met:

(a) The authorisation shall be limited to a maximum of two years.

(b) The competent Sanitary Administrations shall carry out official controls on the foodstuffs in which the authorised additive has been used.

(c) A special indication may be given in the authorisation for the labelling of the foodstuffs manufactured with the authorised additive.

Within two months from the date on which that decision takes effect, the text of the authorisation adopted shall be communicated to the other Member States and to the Commission of the European Communities.

2.5 No food shall contain additives which are not included in the relevant positive list, unless its presence in it is solely due to the fact that it is contained in one or more of its ingredients, for which it is they are legally authorized and provided that they do not fulfil technological function in the final product. "

" Article 3. Classification.

The following categories of food additives are established according to your action:

Colorant.

Conservative.

Antioxidant.

Emulsifiers.

Cast Sales.

Thickener.

Gelling.

Stabilizer (foam stabilizers are included in this category).

Flavor Enhancer.

Acidulant.

Acidity correction (pH regulations can be performed in both directions).

Anti-caking.

Modified starch.

Sweetener.

Gasifying.

Antifoaming.

Coating agent (dismolders are included in this category).

flour treatment agent.

Hardening.

Moisturizer.

Sequester.

Enzymes (only enzymes that have additive function are included in this category).

Agent, load.

Propelling gas and packaging gas.

The inclusion of food additives in any of these categories will be carried out according to the main function normally associated with them. However, classification in a particular category shall not exclude the possibility that the additive may be authorised for other functions. '

" Article 8. Tagged.

8.1 Food additives that are not intended for sale to the final consumer.

These additives may be marketed only if their packaging or packaging bears visible, clearly legible and indelible characters and expressed at least in the official Spanish language of the State, the following indications:

8.1.1 Naming.

8.1.1.1 Food additives sold separately or mixed together.

For each additive, it must be in descending order of the weight weight relative to the total:

-The name set on the corresponding positive list and its CEE number. In the case of no EEC number, the number assigned in the Resolution of 23 July 1987 on the identification numbers of food additives ("Official State Gazette" of 4 August 1987) is replaced by the number assigned in the Resolution of 23 July 1987. 1987).

-If the data listed in the preceding paragraph are not available, a description of the additive shall be included which is sufficiently precise to allow it to be distinguished from other additives with which it may be confused.

8.1.1.2 Food additives to which other substances are incorporated:

-When other substances, materials or food ingredients are incorporated into the additives, in order to facilitate the storage, sale, standardisation, dilution or dissolution of one or more food additives, the name the additive, in accordance with the provisions of 8.1.1.1, as well as the indication of each component, in descending order with respect to the weight of the total.

8.1.2 The indication "for use in foodstuffs" or "for food products, limited use", or a more specific indication of the food use to which the additive is intended.

8.1.3 Specific conservation and utilization conditions, where necessary.

8.1.4 Instructions for use, if the omission of these instructions does not allow the use of the additive.

8.1.5 Identification of the manufacturing batch.

8.1.6 The name or the name and the name and address of the manufacturer or packer or a seller established in the European Economic Community.

8.1.7 The indication of the percentage of any component whose incorporation into a food is subject to a quantitative limitation, or adequate information on the composition so that the buyer can abide by the provisions or, failing that, the national provisions applicable to the food in question. Where the same quantitative limitation applies to a group of components used separately or in combination, the combined percentage may be indicated by a single figure.

8.1.8 Net quantity.

8.1.9 Without prejudice to the foregoing paragraphs, the particulars referred to in the second indent of 8.1.1.1 and paragraphs 8.1.4, 8.1.5, 8.1.6 and 8.1.7 may appear only in the commercial documents relating to the the consignment, which must be submitted at the time of delivery or before delivery, provided that, instead of the packaging or packaging of the product in question, the indication ' for the manufacture of foodstuffs, with exclusion, is given of any retail sale ".

8.2 Food additives intended for direct sale to the final consumer.

These additives may be placed on the market only if the packages or packages containing them bear, in visible, clearly legible and indelible characters, expressed in the form provided for in Article 19 of Royal Decree 1122/1988, 23 September, approving the general rule on the labelling, presentation and advertising of packaged food products, the following indications:

8.2.1 The sales denomination of the product. This name shall be composed of the name in the positive lists and their EEC number or, failing that, the number assigned in the Resolution of 23 July 1987 updating the identification numbers of the additives. food ("Official State Gazette" of 4 August) or a description of the additive which is sufficiently precise to allow it to be distinguished from other additives with which it may be confused.

8.2.2 The information required in paragraphs 8.1.1 to 8.1.6 and 8.1.8.

8.2.3 The date of minimum duration to be expressed in accordance with the provisions of Royal Decree 1122/1988 of 23 September 1988 on the general rule of labelling, presentation and advertising of products packaged food.

8.3 The provisions contained in paragraphs 8.1 and 8.2 do not affect the most detailed or most comprehensive laws, regulations or administrative provisions relating to metrology or presentation, classification, packaging and labelling of dangerous substances and preparations or the transport of such substances. "

" ATTACHED 3

General criteria for the use of food additives

1. Food additives may only be approved when:

-A sufficient technological need can be demonstrated and when the objective sought cannot be achieved by other economically and technologically usable methods.

-Do not pose any danger to the consumer in the proposed doses, in so far as it is possible to judge on the scientific data available.

-Do not mislead the consumer.

2. The use of a food additive can only be considered once proven that the proposed use of the additive reports to the consumer demonstrable advantages; in other words it is advisable to test what is commonly called a "necessity". The use of food additives shall meet the objectives set out in points (a) to (d), and shall only be justified where those objectives cannot be achieved by other economic methods and are practically usable and are not at risk. for the health of the consumer.

a) Preserve the nutritional quality of food: The deliberate reduction of the nutritional quality of a food will only be justified if the food does not constitute an important element of a normal regime, or if the additive is necessary for the production of food intended for groups of consumers with special nutritional needs.

b) Provide the ingredients or constituents needed for food products manufactured for consumer groups that have special nutritional needs.

c) Increase the storage time or stability of a food or improve its organoleptic properties, provided that the nature, essence or quality of the food is not altered in a way that may mislead the consumer.

d) Assist in the manufacture, processing, preparation, processing, packaging, transport or storage of food; provided that the additive is not used to conceal defects in the use of defective raw materials or methods undesirable (including unhygienic) along any of those activities.

3. In order to determine the possible harmful effects of a food additive or its derivatives, it shall be subjected to appropriate toxicological tests. Such an assessment should also take into account any cumulative, synergistic or reinforcing effects dependent on their use, as well as the phenomenon of human intolerance to substances that are foreign to the organism.

4. All food additives must be kept under permanent observation and be evaluated again whenever necessary, taking into account variations in conditions of use and new scientific data.

5. Food additives must always comply with the approved purity criteria.

6. The approval of food additives shall:

(a) Specify the food products to which such additives may be added, as well as the conditions for such addition.

b) Limit to the minimum dose needed to achieve the desired effect.

(c) Take into account any acceptable daily doses or equivalent data, established for the food additive, and the likely daily contribution of that additive in all foodstuffs. Where the food additive is to be used in products consumed by special groups of consumers, account should be taken of the possible target dose of that additive for that group of consumers. '

ADDITIONAL DISPOSITION

This Royal Decree is dictated by the provisions of article 149.1.16. of the Spanish Constitution.

TRANSIENT DISPOSITION

The provisions of Article 8. 'Labelling' of the rules shall not be required until 28 December 1991, in addition to products labelled in accordance with the provisions of Article 8. Royal Decree 3177/1983 of 16 November 1983, which is amended, may continue to be placed on the market until the date set out above.

REPEAL PROVISION

Repealed:

-Chapters XXXI, XXXII, XXXIII and XXXIV of the Spanish Food Code, approved by Decree 2484/1967, of 21 September.

-The references made to paragraph 3.2.9 in Article 5., to paragraph 8.4 of Article 7 (3) (3), and paragraphs 7.4.4 of Article 7 (4) of Article 11 of the technical-health regulation of additives food approved by Royal Decree 3177/1983 of 16 November ("Official State Gazette" of 28 December).

Given in Madrid to July 12, 1991.

JOHN CARLOS R.

The Minister of Relations with the Courts and the Government Secretariat,

VIRGILIO ZAPATERO GOMEZ