Real Decree 640 / 2015, Of 10 Of July, By Which Is Approves The List Of Co-Formulants Technological Authorized For The Elaboration Of Oils Vegetable Edible And Their Criteria Of Identity And Purity, And By Which Is Modifies The Real Decree 308 / 1...

Original Language Title: Real Decreto 640/2015, de 10 de julio, por el que se aprueba la lista de coadyuvantes tecnológicos autorizados para la elaboración de aceites vegetales comestibles y sus criterios de identidad y pureza, y por el que se modifica el Real Decreto 308/1...

Read the untranslated law here: http://www.boe.es/buscar/doc.php?id=BOE-A-2015-8443

Them adjuvants technological authorized in the elaboration of oils vegetable edible is are collected in the order of 13 of January of 1986 by which is approves the list positive of additives and adjuvants technological for use in the elaboration of oils vegetable edible.

Following the approval of Royal Decree 472/1990, of 6 April, which regulates extraction solvents used in the production of foodstuffs and ingredients and of the Royal Decree 145/1997, 31 January, which approves the positive list of additives other than colorants and sweeteners for use in the manufacture of food products as well as their conditions of use, were repealed paragraphs 1 and 2.1 of annex 1 of the order of 13 January 1986, referred to the additives permitted in olive oil and pomace oils and oilseeds extraction solvents. Food additives legislation is currently approved by Regulation (EC) No. 1333 / 2008 of the European Parliament and of the Council of 16 December 2008 on food additives, and the relative to extraction, by the Royal Decree 1101 solvents / 2011, 22 of July, which approves the positive list of extraction solvents which can be used in the manufacture of food products and food ingredients , that repealed expressly the Royal Decree 472 / 1990, of 6 in April.

Also, keep in mind Regulation (EU) No. 1308 / 2013 of the European Parliament and of the Council of 17 December 2013, by establishing the common organisation of markets in agricultural products and that repealing Regulations (EEC) No. 922/72, (EEC) No. 234/79, (EC) No. 1037 / 2001 and (EC) No. 1234 / 2007 It excludes the use of chemical or biochemical action in Virgin olive oil obtaining AIDS.

Moreover, the order of 13 of January of 1986 has been modified in three occasions for its adaptation to them knowledge scientific or technical, the last of them through it order of 18 of December of 1995 by which is modifies it of 13 of January of 1986 by which is approves it list positive of additives and adjuvants technological for use in the elaboration of oils vegetable edible. By this standard were incorporated into the positive list before mentioned adjuvants filtration for Virgin olive oils.

For the sake of clarity and rationality it should be repealed the order of 13 January 1986, replaced by the present Royal Decree that recast in a single text all the changes since its publication in 1986.

Additionally, is established provisions relating to them specifications of them adjuvants technological, as requirement that guarantees the security of them food obtained through the employment of these substances, and is incorporates formally to the Committee scientific of the Agency Spanish of consumption, security food and nutrition (AECOSAN) as body responsible of the evaluation of the risk of them adjuvants technological that not listed in the annex I and whose inclusion can ask is in the future.

Also is updated it list of adjuvants technological authorized for it development of oils vegetable edible, incorporating it clay filosilicate, that has been evaluated by the Committee scientific of it agency Spanish of consumption, security food and nutrition and whose report Pro has been published in the website of the AECOSAN (http://www.aecosan.msssi.gob.es/).

Article 3, paragraph 2, letter b) of Regulation (EC) No. 1333 / 2008 of the European Parliament and of the Council of 16 December 2008, establishes that by «adjuvant technology» shall mean, inter alia, any substance that may result in the unintentional, but technically unavoidable presence in the final product of residues of the substance itself or its derivatives provided that they do not present any health risk and do not have any technological effect in the final product, which makes the health concern low. However, its importance of face to the process of elaboration of them oils vegetable edible can be high, with a great impact on the sector, and its incidence in the quality end can be of great relevance, determining even that adjuvants technological that are safe from the point of view of evaluation of the risk to the consumer, in accordance with the opinion of the Committee scientific of the Agency Spanish of consumption , Food security and nutrition, not may be in the list of co-Formulants technological authorized. It is therefore necessary to have a favourable report from the Ministry of agriculture, food and environment before the steps of the risk assessment and inclusion of a new technological adjuvant in the list.

Additionally, is necessary modify the point 5 of the paragraph V Real Decree 308 / 1983, of 25 of January, by which is approves the regulations health of oils vegetable edible, to delete them references to them solvents of extraction, that is are regulated by the Real Decree 1101 / 2011, of 22 of July.

Finally, this provision is adopted on a regulatory basis, since, in accordance with the doctrine of the Constitutional Court, is considered making the regulated matter that formal law is not the ideal instrument to regulate exhaustively all basic aspects due to the markedly technician and conjunctural and changing nature of this matter.

This real Decree has been subject to the procedure of information in matter of standards and regulations technical and of regulations relating to them services of the society of the information, regulated in the Real Decree 1337 / 1999, of 31 of July, to them effects of give compliance to it willing in the Directive 98 / 34 / EC of the Parliament European and of the Council June 22, 1998, as amended by Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998.

In its processing have been heard the autonomous communities and the cities of Ceuta and Melilla, the sectors concerned, the Council of consumers and users and it has issued mandatory report of the inter-ministerial Commission for food management.

In his virtue, a proposal from the Minister of health, social services and equal, according to the Council of State and after deliberation by the Council of Ministers at its meeting of July 10, 2015, HAVE: article 1. Object.

This Royal Decree is intended to approve the list of co-Formulants technological authorized for the manufacture of edible vegetable oils, contained in annex I, as well as the criteria for identity and purity of them, listed in annex II, with the exception of extraction solvents, which are regulated by the Royal Decree 1101 / 2011, 22 July , by which is approves the list positive of the solvents of extraction that is can use in the manufacturing of products food and of their ingredients.

Article 2. Definitions.

(For the purposes of the present real Decree is apply the definition of adjuvant technological that figure in the letter b) of the paragraph 2 of the article 3 of the regulation 1333 / 2008 of the Parliament European and of the Council, of 16 of December of 2008, on additives food, as well as them definitions included in the Real Decree 308 / 1983, of 25 of January, by which is approves the regulations health of oils vegetable edible.

Article 3. Conditions of use.

1. only may use is in the processing of oils vegetable edible them adjuvants technological that listed in the annex I of this real Decree, in them conditions there specified, and that comply with them criteria of identity and purity of the annex II of this real Decree.

2. them adjuvants technological is used so the amount used is limited to the dose minimum required to get the effect desired.

Article 4. Identity and purity criteria.

1. the technological adjuvants referred to in annex I must meet the identity and purity criteria set out in annex II.

2. without prejudice to the provisions of paragraph 1, the technological adjuvants shall be made so that, in the normal or foreseeable conditions of use, they do not transfer oils components that may pose a risk to human health.

Article 5. Sanctioning regime.

Failure to comply with the provisions of this Royal Decree shall be subject to sanction, administrative instruction of the appropriate administrative proceedings, in accordance with the provisions of the law 17/2011, July 5, of food security and nutrition.

First additional provision. Mutual recognition clause.

The requirements of this Royal Decree shall not apply to vegetable edible oils lawfully manufactured or marketed in the other Member States of the European Union, or to products originating in countries of the European Association of free trade (EFTA), Contracting Parties to the agreement on the European economic area (EEA), or States that have an agreement of Association customs with the European Union.

Provision additional second. Expenditure public.

The regulation included in this standard do not can assume increase of expenditure public.

Sole repeal provision. Repeal legislation.


The order of 13 January 1986 which approves the list of positive additives and processing aids shall be repealed technology for use in the manufacture of edible vegetable oils, as well as all provisions of equal or lower rank insofar as they oppose the provisions of this Royal Decree.

Available end first. Title competence.

This Royal Decree is dictates to the amparo of it established in the article 149.1.16. ª of the Constitution, that attributed to the State the competition exclusive in matter of bases and coordination general of it health.

Available to finish second. Modification of the Real Decree 308/1983, of 25 January, which approves the Reglamentación of edible vegetable oils.

He point 5 of the paragraph V of it regulation health of oils vegetable edible, approved by the Real Decree 308 / 1983, of 25 of January, is modified as follows: «5 adjuvants technological: he Government approve it list positive of adjuvants technological that may use is in them products regulated in the present regulation.»

Available to finish third. Enabling legislation.

1 authorizing the titular person of the Ministry of health, social services and equality to dictate, in the field of its competences, the necessary arrangements for the updating and modification of annexes I and II of this Royal Decree to adapt it to scientific and technical knowledge, and the rules of the European Union that are approved, if , on the matter.

2. them adjuvants technological that not listed in the annex I of this real decree must be object, for its approval e inclusion in said Annex I, of an evaluation from the Committee scientific of the Agency Spanish of consumption, security food and nutrition that set the security of the use planned, prior report favorable of the address General of it industry food of the Ministry of agriculture , Power and environment.

Fourth final provision. Entry into force.

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

Given in Madrid, the 10 of July from 2015.

PHILIP R.

The Minister of health, services social e equality, ALFONSO ALONSO ARANEGUI ANNEX I list of adjuvants technological authorized for the elaboration of oils vegetable edible name category type of oil conditions of use / function quantity maximum residual silicate magnesico hydrated (TALC natural).





Adjuvant of extraction.





Oils of olive Virgin.





Dose strictly necessary to achieve the effect technology.





Technically unavoidable.






Clay filosilicate.





Adjuvant of extraction.





Virgin olive oils.





Dose strictly necessary to achieve the technological effect.





Technically unavoidable.






Citric acid, including their sodium salts.





Fining agent.





Refined vegetable oils.





Dose strictly necessary to achieve the technological effect.





Technically unavoidable.






Acid L(+) - tartaric, including their sodium salts.





Fining agent.





Refined vegetable oils.





Dose strictly necessary to achieve the technological effect.





Technically unavoidable.






Phosphoric acid, including their sodium salts.





Fining agent.





Refined vegetable oils.





Dose strictly necessary to achieve the technological effect.





Technically unavoidable.






Sodium hydroxide.





Neutralization agent.





Refined vegetable oils.





Dose strictly necessary to achieve the effect technology.





Technically unavoidable.






Hydroxide potassium.





Agent of neutralization.





Oils vegetable refined.





Dose strictly necessary to achieve the effect technology.





Technically unavoidable.






Carbonate sodium.





Agent of neutralization.





Refined vegetable oils.





Dose strictly necessary to achieve the technological effect.





Technically unavoidable.






Potassium carbonate.





Neutralization agent.





Refined vegetable oils.





Dose strictly necessary to achieve the technological effect.





Technically unavoidable.






Sodium chloride (salt for food).





Neutralization agent.





Oils vegetable refined.





Dose strictly necessary to achieve the effect technology.





Technically unavoidable.






Land bleaching activated (activated by heat or acid citric, tartaric, phosphoric, hydrochloric or sulfuric).





Agent bleaching.





Oils vegetable refined.





Dose strictly necessary to achieve the effect technology.





Technically unavoidable.






Bentonite.





Agent bleaching.





Refined vegetable oils.





Dose strictly necessary to achieve the technological effect.





Technically unavoidable.






Activated charcoal (activated by heat or citric, tartaric, phosphoric, hydrochloric or sulfuric acid).





Bleaching agent.





Refined vegetable oils.





Dose strictly necessary to achieve the technological effect.





Technically unavoidable.






Dioxide of Silicon (Silica Gel).





Bleaching agent.





Oils vegetable refined.





Dose strictly necessary to achieve the effect technology.





Technically unavoidable.






Nitrogen.





Adjuvant of conservation.





Oils vegetable.





Dose strictly necessary to achieve the effect technology.





Technically unavoidable.






Filters of cotton.





An aid of filtration.





Vegetable oils.





Dose strictly necessary to achieve the technological effect.





Technically unavoidable.






Cellulose filters.





Filtration adjuvant.





Vegetable oils.





Dose strictly necessary to achieve the technological effect.





Technically unavoidable.






Diatomite or diatomaceous earth.





Filtration adjuvant.





Oils vegetable.





Dose strictly necessary to achieve the effect technology.





Technically unavoidable.





ANNEX II criteria for identity and purity of the adjuvants technology 1. The substances used as adjuvants technological planned in the annex I that appear related then must meet the following criteria of identity and purity: 1.1 clay filosilicate.




Definition.





The clay filosilicate is a clay plastic white purified composed by kaolinite (at least the 80%), Montmorillonite, illite and quartz. The treatment not must include the calcination. He level of dioxin of the clay filosilicate in gross used in the production not must make it harmful for the health or not suitable for the consumption human.






No. Einecs.





215-286-4 (kaolinite).






Chemical formula.





[Al2Si2O5 (OH) 4] (kaolinite).






Molecular weight.





264 determination.





Not less than 90% (sum of silica and alumina, after combustion).

Silica (Si02): Between 45% and 55%.

Alumina (Al203). Between 30% and 39%.






Description.





Unctuous powder fine, white or greyish white. Clay filosilicate is composed of loose aggregates of randomly oriented blocks of kaolinite or insulated hexagonal scales flake.






ID: A. positive tests for alumina and silicate.





 






B. x-ray diffraction.





Characteristic peaks at 7.18/3.58/2.38/1.78 to.






C. IR absorption.





Peaks at 3,700 and 3,620 cm-1 purity: moisture.