The processing aids authorized in the production of edible vegetable oils are included in the Order of 13 January 1986 approving the positive list of additives and processing aids. for use in the manufacture of edible vegetable oils.

Following the approval of Royal Decree 472/1990 of 6 April 1990 regulating extraction solvents used in the manufacture of foodstuffs and their ingredients and of Royal Decree 145/1997 of 31 January 1997, approving the positive list of additives other than colours and sweeteners for use in the production of foodstuffs, as well as their conditions of use, paragraphs 1 and 2.1 of Annex 1 to the Order of 13 were repealed. of January 1986, referring to the additives permitted in olive oil and extraction solvents olive-pomace oils and oilseeds. Currently, the rules applicable to food additives are approved by Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives and on food additives. extraction, by means of Royal Decree 1101/2011 of 22 July 2011, approving the positive list of extraction solvents which can be used in the manufacture of foodstuffs and their ingredients, which expressly repealed the Royal Decree 472/1990 of 6 April.

It should also be taken into account that Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and establishing a common organisation of the market in agricultural products Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 exclude the use of chemical or biochemical action in the production of virgin olive oil.

On the other hand, the Order of 13 January 1986 has been amended three times in order to adapt it to scientific or technical knowledge, the last of which is the Order of 18 December 1995 amending on 13 January 1986 approving the positive list of additives and processing aids for use in the manufacture of edible vegetable oils. By that standard, the filtration aids for virgin olive oils were added to the above positive list.

For the sake of greater rationality and clarity, the Order of 13 January 1986 should be repealed, replacing it with the present royal decree which will recast in a single text all the changes produced since its publication in the year 1986.

Additionally, provisions concerning the specifications of the processing aids are laid down, as a requirement that guarantees the safety of the food obtained through the use of these substances, and is incorporated formally to the Scientific Committee of the Spanish Agency for Consumption, Food Safety and Nutrition (AECOSAN) as the body responsible for assessing the risk of technological adjuvants not listed in Annex I and the inclusion of which may to be asked in the future.

The list of authorized processing aids for the manufacture of edible vegetable oils is also updated, incorporating the kaolinitic clay, which has been evaluated by the Scientific Committee of the Spanish Agency of Consumption, Food Security and Nutrition and whose favorable report has been published on the AECOSAN website (http://www.aecosan.msssi.gob.es/).

Article 3 (2) (b) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 provides that 'technological aid' shall mean, inter alia, any substance which may give rise to the inadvertent, but technically unavoidable, presence in the final product of residues of the substance or its derivatives, provided that they do not present any risk to health and do not have any technological effect on the Final product, which makes the health concern low. However, its importance for the process of making edible vegetable oils can be high, with a great impact on the sector, and its impact on final quality can be of great relevance, even if (i) technological aids which are safe from the point of view of consumer risk assessment, in accordance with the opinion of the Scientific Committee of the Spanish Agency for Consumption, Food Safety and Nutrition, cannot be incorporated into the list of authorised processing aids. It is therefore necessary to have a favourable report from the Ministry of Agriculture, Food and the Environment before starting the risk assessment procedures and the inclusion of a new technological co-adjuvant in the list.

Additionally, it is necessary to amend point 5 of paragraph V Royal Decree 308/1983, of 25 January, approving the Technical-Health Regulations of edible vegetable oils, in order to eliminate the references to the extraction solvents, which are regulated by Royal Decree 1101/2011 of 22 July.

Finally, this provision is adopted on a regulatory basis, since, in accordance with the Constitutional Court's doctrine, it is considered that the regulated matter makes the formal law not the ideal instrument for regulating exhaustively all the basic aspects due to the markedly technical nature and the cyclical and changing nature of this matter.

This royal decree has been subject to the procedure of information in the field of technical norms and regulations and regulations concerning the services of the information society, regulated in Royal Decree 1337/1999, For the purposes of implementing Directive 98 /34/EC of the European Parliament and of the Council of 22 June 1998, as amended by Directive 98 /48/EC of the European Parliament and of the Council of 20 July 1998

Directive 98 /34/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 affected, the Council of Consumers and Users and has issued precept report the Inter-Ministerial Commission for the Food.

In its virtue, on the proposal of the Minister of Health, Social Services and Equality, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting of July 10, 2015,

DISPONGO:

Article 1. Object.

This royal decree aims to approve the list of technological adjuvants authorised for the production of edible vegetable oils, listed in Annex I, as well as the criteria for their identity and purity, listed in Annex II, with the exception of extraction solvents, which are regulated by Royal Decree 1101/2011 of 22 July 2011 approving the positive list of extraction solvents which can be used in the manufacture of food products and their ingredients.

Article 2. Definitions.

For the purposes of this royal decree, the definition of the technological aid referred to in Article 3 (2) (b) of Regulation 1333/2008 of the European Parliament and of the Council of 16 December 2008 shall apply. on food additives, as well as the definitions contained in Royal Decree 308/1983 of 25 January, approving the Technical-Health Regulations for edible vegetable oils.

Article 3. Conditions of use.

1. Only the processing aids listed in Annex I to this royal decree, under the conditions specified therein, and meeting the identity and purity criteria of the Annex, may be used in the manufacture of edible vegetable oils. II of this royal decree.

2. The processing aids shall be used in such a way that the quantity used shall be limited to the minimum dose required to obtain the desired effect.

Article 4. Identity and purity criteria.

1. The processing aids set out in Annex I shall comply with the identity and purity criteria set out in Annex II.

2. Without prejudice to paragraph 1, the processing aids shall be manufactured so that, under normal or foreseeable conditions of use, they do not transfer to the oils component which may present a risk to the human health.

Article 5. Sanctioning regime.

Failure to comply with this royal decree may be the subject of an administrative penalty, subject to the instruction of the appropriate administrative file, in accordance with the provisions of Law 17/2011 of 5 July, food security and nutrition.

Additional disposition first. Mutual recognition clause.

The requirements of this royal decree shall not apply to edible vegetable oils lawfully manufactured or marketed in the other Member States of the European Union, or to products originating in the countries of the European Union. European Free Trade Association (EFTA), Contracting Parties to the Agreement on the European Economic Area (EEA), or to States which have a Customs Association Agreement with the European Union.

Additional provision second. Public expenditure.

The regulation included in this rule will not be able to increase public spending.

Single repeal provision. Regulatory repeal.

The Order of 13 January 1986 approving the positive list of additives and processing aids for use in the manufacture of edible vegetable oils, as well as all those standards of equal or equal treatment, is hereby repealed. lower rank as soon as they object to the provisions of this royal decree.

Final disposition first. Competence title.

This royal decree is dictated by the provisions of article 149.1.16. of the Constitution, which attributes to the State exclusive competence in the field of bases and general coordination of health.

Final disposition second. Amendment of Royal Decree 308/1983 of 25 January on the approval of the Technical-Health Regulations for edible vegetable oils.

Point 5 of paragraph V of the Technical-Health Regulations for Edible Vegetable Oils, approved by Royal Decree 308/1983 of 25 January, is amended as follows:

" 5 Technology adjuvants:

The Government shall approve the positive list of technological adjuvants that may be used in the products covered by this Regulation. "

Final disposition third. Regulatory enablement.

1. The person holding the Ministry of Health, Social Services and Equality is hereby authorised to make the necessary arrangements for updating and amending Annexes I and II to this royal decree in the field of their powers. adapt it to scientific and technical knowledge, and to the rules of the European Union which are adopted, where appropriate, on the subject.

2. The processing aids not listed in Annex I to this royal decree shall, for approval and inclusion in Annex I, be subject to an assessment by the Scientific Committee of the Spanish Agency for Consumer Protection. Food and Nutrition to establish the safety of the intended use, prior to the favorable report of the Food Industry Directorate General of the Ministry of Agriculture, Food and Environment.

Final disposition fourth. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, July 10, 2015.

FELIPE R.

The Minister of Health, Social Services and Equality,

ALFONSO ALONSO ARANEGUI

ANNEX I

List of authorised processing aids for the production of edible vegetable oils

	Category	Oil Type	Usage/Function Conditions	Maximum residual
hydrated magnesium silicate (natural talc).	Extraction Coadjuvant.	Olive Oils virgins.	Dose strictly necessary to achieve the technological effect.	Technically unavoidable
Extraction Coadjuvant.		Virgin olive oils.	Dose strictly necessary to achieve the technological effect.		Citric acid, including its sodium salts.
Clarification agent.	Refined plant oils.	Dose strictly necessary to achieve the technological effect.	Technically unavoidable.
L (+)-tartaric acid, including its salts	Clarification agent.	Refined vegetable oils.	Dose strictly necessary for achieve the technological effect.	Technically unavoidable
phosphoric acid, including its sodium salts.	Clarification Agent.	Vegetable Aceites refined.	Dose strictly necessary to achieve the technological effect.	Technically unavoidable
Sodium hydroxide.	Neutralization agent.	Refined vegetable oils.	Dose strictly necessary to achieve the technological effect.	Technically unavoidable
Potassium hydroxide.	Neutralization agent.	Refined Vegetable Oils.	Dose strictly necessary to achieve the technological effect.	Technically unavoidable.
carbonate.	Neutralization Agent.	Refined vegetable oils.	Dose strictly necessary to achieve the technological effect.	Technically unavoidable.
Potassium carbonate.	Neutralization agent.	Refined vegetable oils.	Dosage strictly necessary to achieve the technological effect.	Technically unavoidable.
chloride (salt for power).	Neutralization agent.	Refined vegetable oils.	Strictly required dosage to achieve the technological effect.	Technically unavoidable
activated decolorants (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.
Bentonite.	Decoloring agent.	Refined vegetable oils.	Dose strictly necessary to achieve the technological effect.	Technically unavoidable
activated (activated by heat or acid citric, tartaric, phosphoric, hydrochloric or sulphuric.	Decolorating Agent.	Refined vegetable oils.	Dose strictly necessary to achieve the technological effect.	Technically unavoidable.
dioxide (silica gel).	Decoloring agent.	Refined vegetable oils.	Dosage strictly necessary to achieve the technological effect.	Technically unavoidable.
Nitrogen.	Conservation aid.	Vegetable oils.	Dose strictly necessary to achieve the effect	Technically unavoidable
Cotton filters.	Filtering adjuvant.	Vegetable oils.	Dosage strictly necessary to achieve the technological effect.	Technically unavoidable
cellulose filters.	Filtering adjuvant.	Aceites	Dose strictly necessary to achieve the technological effect.	Technically unavoidable
Earth of infusoriums or diatoms.	Filtering adjuvant.	Vegetable oils.	Dosage strictly necessary to achieve the technological effect.	Technically unavoidable

ANNEX II

Identity and purity criteria of the processing aids

1. The substances used as processing aids provided for in Annex I listed below shall comply with the following identity and purity criteria:

1.1 Caolinitic Clay.

Definition.

The kaolinitic clay is a purified white plastic clay composed of kaolinite (at least the 80%), montmorillonite, ilite and quartz. Treatment should not include calcination. The level of dioxins of the raw kaolinitic clay used in the production should not be harmful to health or unfit for human consumption
Einecs.	215 -286-4 (kaolinite).
Formula.	[Al2If2Or5(OH)4] (kaolinite)
Weight.	264
Determination.	Not less than 90% (sum of silica and alumina, after combustion). Silice (Si02): Between 45% and 55%. Alumina (Al203). Between 30 and 39%.
Description.	A fine, white, or white gray powder. The kaolinitic clay is composed of loose aggregates of randomly oriented blocks of caolinite esbed or isolated hexagonal scales
Identification: A. Positive tests for alumina and silicate.
B. X-ray diffraction.	Typical values at 7 ,18/3.58/2, 38/1, 78 A.
C. IR absorption.	Maximum values to 3,700 and 3,620 cm-1
purity: humidity.		Between 10% and 14% (1000 °C, constant weight)
	Not more than 0.3%.
-soluble matter.	No more than 2%.
.	No more than 3%.
Potassium Oxide (K20).	No more than 2%.
	Not more than 0.5%
No more than 3 mg/kg.
.	Not more than 70 mg/kg.
Mercury.	No more than 1 mg/kg.
Cadmium.	No more than 2 mg/kg.

1.2 Bentonite.

Definition.

The bentonite is a natural clay with great content in smectite, a native hydrated silicate of aluminum in which some aluminum and silicon atoms were naturally replaced by other atoms, such as magnesium and iron. Calcium and sodium ions are trapped between the mineral layers. There are four common types of bentonite: natural sodium bentonite, natural calcium bentonite, sodium-activated bentonite, and acid-activated bentonite.
N. Einecs.	215 -108-5.
Formula.	(Al, Mg)8 (If4Or10)4 (OH)8 12H2
Weight.	819.
Content.	Esmectite: no less than 80%.
Description.	Very fine, yellowish, or greyish white powder. The structure of the bentonite allows you to absorb water inside and on the surface (swelling properties)
Identification: A. Test methylene blue.
B. X-ray diffraction.	Maximum values characteristic at 12 ,5/15 A
C. IR absorption.	Maximum values at 428/470/530/1 110-1 020/3 750-3400 cm-1
	Purity: Loss by desiccation.	No more than 15.0% (105 orC, 2 h).
arsenic.	No more than 2 mg/kg.
..	No more than 20 mg/kg.

2. If the substances used as processing aids as provided for in Annex I are not included in paragraph 1 of this Annex but are included in Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council, On 16 December 2008, on food additives, they shall comply with the identity and purity criteria adopted in Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for additives. food listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives.

3. If the substances used as processing aids as provided for in Annex I are not included in paragraph 1 of this Annex or in Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008, 2008, the identity and purity criteria laid down by the European Pharmacopoeia or by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) or, in the absence thereof, shall apply with the following general purity criteria:

Lead: < 5 mg/kg.

Arsenic: < 1 mg/kg.

Mercury: < 1 mg/kg.

Cadmium: < 1 mg/kg.