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Royal Decree 1262 / 2005, Of 21 October, Amending The Royal Decree 118/2003, 31 January, Which Approves The List Of Substances Permitted For The Manufacture Of Plastic Materials And Articles Intended To Come Into Contact...

Original Language Title: Real Decreto 1262/2005, de 21 de octubre, por el que se modifica el Real Decreto 118/2003, de 31 de enero, por el que se aprueba la lista de sustancias permitidas para la fabricación de materiales y objetos plásticos destinados a entrar en contacto ...

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Royal Decree 118/2003 of 31 January approving the list of permitted substances for the manufacture of plastic materials and articles intended to come into contact with food and are regulated test conditions, in a single text fuses the Royal Decrees 2207/1994 of 16 November, 1752/1998 of 31 July 1998, and 442/2001 of 27 April, and incorporates into Spanish law the Commission Directive 2001 /62/EC of 9 August 2001. of 2001. Furthermore, the provisions of Commission Directive 2002/72/EC of 6 August 2002 on the codification of Directive 90 /128/EEC and its subsequent amendments, other than those introduced, are laid down in that Royal Decree. by Directive 2002/17/EC of the European Parliament and of the Council of 21 February 2002.

Subsequently, Order SCO/983/2003, of 15 April, amending the Annexes to Royal Decree 118/2003, of 31 January, incorporates in our legal order the aforementioned Directive 2002/17/EC, in order to adapt the provisions in force on new information available on plastic materials and articles intended to come into contact with foodstuffs. The use of azodicarbonamide as a foaming agent or expander of plastic materials and articles intended to come into contact with foodstuffs is authorised in Royal Decree 118/2003 of 31 January 2003, in accordance with the Opinion of the Scientific Committee for Food. Azodicarbonamide is used as an expander agent in the manufacture of plastic gaskets intended for metal lids of glass flasks. New studies have shown that azodicarbonamide is broken down into semicarbacid (hereinafter SEM) by heat action applied during the manufacture of the inflated joint and during the sterilisation of the sealed glass bottle. According to the existing scientific information, it has been concluded that SEM presents a slight carcinogenic activity in laboratory animals and some in vitro genotoxicity, but that the current state of scientific knowledge does not allows to determine whether SEM presents a carcinogenic risk to humans. However, taking into account current information on the levels of SEM in food, their intake and toxicology, as well as the likely risk for both young children and adults, it is recommended to reduce the levels of SEM in food. I would like to point out that the Commission has not been able to do so. Therefore, taking into account the scientific uncertainty that still exists in this respect, in order to achieve the high level of health protection to which the European Union is aiming, the use of the azodicarbonamide of the Union should be provisionally suspended. incomplete list of fully harmonised additives at Community level, in accordance with the precautionary principle set out in Article 7 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002, set out the principles and general requirements of food law, the creation of European Food Safety Authority and procedures relating to food safety, as amended by Regulation (EC) No 1642/2003 of the European Parliament and of the Council of 22 July 2003. The said provisional suspension will take effect as long as the European Community seeks more complete information from other sources, which can clarify the doubts existing in the current knowledge of the SEM. Alternatives to the possible substitution of azodicarbonamide in food packaging materials are being considered without compromising the microbiological safety of food. It is therefore appropriate to provide for a transitional period of 18 months in order to take into account the minimum storage time for such packaged foods. A transitional period should also be established for materials and articles which come into contact with food before the date of application of this Royal Decree. This transitional period should take account of the general rules for the labelling, presentation and advertising of foodstuffs. For the above reasons, Commission Directive 2004 /1/EC of 6 January 2004 amending Directive 2002/72/EC as regards the suspension of the use of azodicarbonamide as an expanding agent. On the other hand, the existence of new scientific data and a review of existing scientific data, based on the evaluations of the European Food Safety Authority (hereinafter the Authority), has led to an update of the lists. Community of authorised substances for plastic materials and articles, including new monomers and additives, and the restrictions and/or specifications laid down for certain substances are amended. To complete the list in force at Community level of additives and to make it a harmonised positive list, data may be submitted to the Authority on additives placed on the market in one or more Member States for the Authority to assess its security. The deadline for submitting such data is 31 December 2006. If the data comply with the requirements of the Authority, the additives may continue to be used in accordance with national legislation until the completion of their assessment. If the data do not comply with the requirements of the Authority or have been submitted after 31 December 2006, the additives should not be included in the first positive list. The date on which the list of additives becomes a positive list should be set within a period of 31 December 2007, taking into account the time required by the Authority to assess all applications submitted within the deadline. Certain substances used to make plastic materials and articles intended to come into contact with food are also directly added to food products, when used as food additives. Those substances, where they are also authorised as a food additive in the foodstuff, must not pass from materials or articles to food in quantities exceeding the limits laid down in the current food law, or in the case of plastic materials and articles intended to come into contact with the food, according to which it establishes the least restriction. In any case, such substances should not pass from materials and articles to foodstuffs in quantities which have a technological effect on the final food. Users of materials and articles that can release such substances into food products should be adequately informed in order to be able to comply with relevant food law. All these considerations have led to the amendment of Directive 2002/72/EC by Commission Directive 2004 /19/EC of 1 March 2004 amending Directive 2002/72/EC on plastic materials and articles intended to come into contact with foodstuffs. This Royal Decree incorporates into our legal order Commission Directive 2004 /19/EC of 1 March 2004, as well as the aforementioned Commission Directive 2004 /1/EC of 6 January 2004. This entails the modification of the contents of several articles of Royal Decree 118/2003 of 31 January, the addition to Section A of Annex II of certain substances, used as monomers and other starting substances, and the deletion of other substances. of Section B of that Annex, as well as the amendment of the restrictions for certain of those substances. In this regard, substances are added to the list of additives in Sections A and B of Annex V to that Royal Decree, others are deleted and the content of the column of restrictions and/or specifications laid down for certain additives is amended. in Annexes V and VI. In addition, the specifications for certain substances in Annex VII are amended and new specifications for other substances are added. The list of additives included in this Royal Decree, which replaces the one set out in Royal Decree 118/2003 of 31 January, and which will be extended in successive stages until a full list is obtained, replaces in part the one contained in the Resolution of The Deputy Secretary for Health, dated 4 November 1982, as amended by the Order of the Ministry of Health and Consumer Affairs of 3 July 1985. Therefore, only additives included in Annex V to this Royal Decree with the restrictions and/or specifications identified therein, as well as those listed in Annex V, may be used in the manufacture of plastic materials and articles. (a) resolution and amendment, which are not provided for in that Annex. This Royal Decree is dictated by the provisions of article 149.1.16. of the Constitution and in accordance with the provisions of article 40.2 and 4 of Law 14/1986 of 25 April, General of Health. In its preparation, the sectors concerned have been heard and the Inter-Ministerial Commission for Food Management has issued its mandatory report. In its virtue, on a proposal from the Ministers for Health and Consumer Affairs, Industry, Tourism and Trade and Agriculture, Fisheries and Food, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 21 March. October 2005,

D I S P O N G O:

Single item. Amendment of Royal Decree 118/2003 of 31 January approving the list of permitted substances for the manufacture of plastic materials and articles intended to come into contact with food and subject to certain conditions test.

Royal Decree 118/2003, dated January 31, is amended as follows: One. Article 5 is worded as follows:

" Article 5. Specific migration limits.

1. The specific migration limits indicated in Annexes II and V are expressed in mg/kg. However, such limits are expressed in mg/dm2 in the following cases: (a) Objects which are packaging or which are comparable to packaging or which can be filled in, of a capacity of less than 500 millilitres (ml) or more than 10 litres. (b) Lamines, films or other materials which cannot be completed or for which it is not possible to calculate the ratio between the surface of such materials and the quantity of food product in contact with them. 2. In the cases referred to in paragraph 1, the limits set out in Annexes II and V, expressed in mg/kg, shall be divided by six, as a conventional conversion factor, to be expressed in mg/dm2. '

Two. Article 6 (3) is worded as follows:

" 3. Verification of compliance with the specific migration limits provided for in paragraph 2 shall not be mandatory if one of the following assumptions can be demonstrated: (a) The value of the overall migration determination implies that the specific migration limits referred to in that paragraph are not exceeded. (b) that the quantity of residual substance in the material or object, even considering the complete migration of the substance or object, does not exceed the specific migration limit. "

Three. Article 7 (1) shall be read as

:

" 1. Only monomers and other starting substances listed in Section A of Annex II may be used for the manufacture of plastic materials and articles, with the restrictions specified therein. However, the monomers and other starting substances included in Section B of Annex II may continue to be used until 31 December 2004 at the latest, pending the completion of the European Food Safety Authority by the European Food Safety Authority. evaluation. "

Four. Article 8 is worded as follows:

" Article 8. Positive list of additives.

1. Additives which may be used in the manufacture of plastic materials and articles, together with the restrictions and, where appropriate, specified specifications, are those set out in Annex V, as well as those contained in the Resolution of the Sub-Secretary for Health, 4 November 1982, and its amendment to the Order of 3 July 1985, which are not provided for in this Royal Decree. The list of additives provided for in Annex V shall be converted into a positive list of single authorised additives, excluding all other additives, when the Community positive list of authorised additives is approved. For the substances of Section B of Annex V, the verification of compliance with the specific migration limits shall apply from 1 July 2006 when it is carried out in simulants D or in the test means of replacement analysis, 2. The lists set out in Sections A and B of Annex V do not yet include the following additives: (a) Additives used solely for the manufacture of: 1. Coatings of surfaces obtained from resinous or polymerized products in liquid form, powder or dispersion, such as varnishes, lacquers, paints. 2. Epoxy resins. 3. Adhesive and adhesion activators. 4. Tintas of printing. b) Colorants. (c) solvents. However, as long as there is no provision to the contrary, all the colouring matters used for the manufacture or manufacture of plastic materials and articles complying with the provisions of paragraph 7.5 of the Article 7 of the Technical-Health Regulations for the elaboration, circulation and trade of plastic materials intended to come into contact with food and food products, approved by Royal Decree 1425/1988 of 25 November. 3. The criteria laid down in this Royal Decree shall apply to the values admitted for specific migrations of additives in which the functional duality of monomer or substance of departure and additive may be presented.

Five. A new Article 9 is added, with the following wording:

" Article 9. Community procedure for the inclusion of additives in the single Community positive list.

1. Those interested in the inclusion of an additive in the next single Community list of authorised additives shall, within a period of 30 September 2006, submit their application together with the precise data for the assessment of the additive. Security for the Spanish Food Safety Agency (AESA), which will transfer those to the European Food Safety Authority. 2. To this end, it will be necessary for the additive to be provided for in the Resolution of the Subsecretariat of Health of 4 November 1982, as amended by the Order of 3 July 1985. 3. The following guidelines of the European Food Safety Authority shall be taken into account for the presentation of the safety assessment data: " Guidelines of the Scientific Committee for Food for the presentation of applications for the safety assessment of a substance to be used in materials intended to be in contact with food prior to authorisation ', which can be found at the following electronic address: http://europea.eu.int/comm/food/sc/scf/out82-en.pdf. 4. With effect from 31 December 2006, EASA may refuse the authorisation of additives for plastic materials intended to come into contact with food which is included in the Resolution of 4 November 1982, as amended by the Order of 3 July 1985, and which have never been evaluated or which have not been evaluated favourably by the Scientific Committee for Food or by the European Food Safety Authority. '

Six. The current Article 9, Products obtained by means of bacterial fermentation, becomes Article 10.

Seven. A new Article 11 is added, with the following wording:

" Article 11. Food additives and flavourings.

1. The additives referred to in Article 8 which are also authorised as food additives by the legislation of food additives, that is, Royal Decree 3177/1983 of 16 November, approving the regulation (a) technical-health food additives, or as flavourings in accordance with Royal Decree 1477/1990 of 2 November 1990 on the technical and health regulation of flavourings used in foodstuffs and materials of the base for their production, they should not migrate: (a) foodstuffs in quantities which have a technological effect on the final foodstuff. (b) foodstuffs in which their use is authorised as additives or flavourings in quantities exceeding the restrictions laid down in the legislation on food additives by Royal Decree 142/2002 of 1 February 2002, approves the positive list of additives other than colours and sweeteners for use in the manufacture of foodstuffs, as well as their conditions of use and subsequent amendments, by Royal Decree 2001/1995 of 7 December 1995, by approving the positive list of colours authorised for use in the preparation of food products, as well as their conditions of use, and successive amendments, and by Royal Decree 2002/1995 of 7 December 1995 approving the positive list of additives authorised for use in the manufacture of food products, as well as their conditions of use, and successive modifications; or of flavourings as provided for in Royal Decree 1477/1990 of 2 November; or in Article 8 of this Royal Decree, taking into account the one established by the largest restriction. (c) foodstuffs in which their use is not authorised as food additives or flavourings in quantities exceeding the restrictions laid down in Article 8. 2. In the marketing stages other than the retail stages, plastic materials and articles intended to be brought into contact with foodstuffs or foodstuffs containing additives or flavourings mentioned in the paragraph 1 shall be accompanied by a written declaration including the information requirements referred to in Article 13.2. "

Eight. The current Article 10, Specifications, becomes Article 12.

Nine. The current Article 11 becomes Article 13 and is worded as follows:

" Article 13. Declaration for marketing.

1. In the marketing stages other than the retail stages, plastic materials and articles intended to be brought into contact with foodstuffs or foodstuffs shall be accompanied by a written declaration that certify that they conform to the rules in force in the matter that apply to them. 2. Where the plastic material contains substances subject to a restriction in the rules of food additives or flavourings or foodstuffs, the said declaration should inform the level of migration of such substances. the food product, either from experimental data or from theoretical estimates of its specific level of migration and, where appropriate, the purity criteria in accordance with Royal Decree 1917/1997 of 19 December 1997, for which the lay down the rules of identity and purity of food additives other than colours and Sweeteners used in foodstuffs, and successive amendments to the Annexes to the said Royal Decree, with Royal Decree 2107/1996 of 20 September 1996 laying down the rules for the identity and purity of colours used in foodstuffs, and successive amendments to the Annexes to the said Royal Decree, as well as to Royal Decree 2106/1996 of 20 September 1996 laying down the rules for the identity and purity of sweeteners used in foodstuffs, and successive amendments to the Annexes to the said Royal Decree. This information should allow the user of such materials and articles to comply with the relevant rules applicable to foodstuffs. "

Ten. Annexes II, V, VI and VII to Royal Decree 118/2003 of 31 January are hereby replaced as set out in the Annex to this Royal Decree.

Single transient arrangement. Dates of application and extensions of marketing.

1. From the entry into force of this Royal Decree, the marketing and import of plastic materials and articles intended to come into contact with foodstuffs containing azodicarbonamide will be prohibited.

However and without prejudice to the general rule on the labelling, presentation and advertising of foodstuffs, plastic materials and articles intended to come into contact with foodstuffs which contain azodicarbonamide and which have been packaged before the entry into force of this Royal Decree may continue to be placed on the market until stocks are exhausted, provided that the date of packaging appears on them, which may be replaced by another an indication provided that the date of packaging is identified. Upon request, the date of packaging shall be provided to the competent authorities and to any person responsible for enforcing the requirements of this Royal Decree. 2. From 1 March 2006, the manufacture and import of plastic materials and articles intended to come into contact with foodstuffs which do not comply with the provisions of this Royal Decree shall be prohibited. However, plastic materials and articles intended to come into contact with foodstuffs, which are on the market before 1 March 2006 and which comply with the provisions of the legislation in force before the end of the year, The entry into force of this Royal Decree, may continue to be placed on the market until the end of its stock.

Single repeal provision. Regulatory repeal.

As many provisions of equal or lower rank are repealed, they oppose the provisions of this Royal Decree and, in particular, Order SCO/983/2003 of 15 April, amending the Royal Decree 118/2003 of 31 January, approving the list of permitted substances for the manufacture of plastic materials and articles intended to come into contact with food and for certain test conditions.

Final disposition first. Competence title.

This Royal Decree is dictated by the provisions of article 149.1.16. of the Constitution and in accordance with the provisions of article 40.2 and 4 of Law 14/1986 of 25 April, General of Health.

Final disposition second. Entry into force.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Given in Madrid, on October 21, 2005.

JOHN CARLOS R.

First Vice-President of the Government and Minister of the Presidency, MARIA TERESA FERNÁNDEZ DE LA VEGA SANZ

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