Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80 /590/EEC and 89 /109/EEC is the regulatory framework in force in all the countries of the European Union on materials and articles intended to come into contact with food.

This Regulation lays down in Article 11 that the Community authorisation of one or more substances must be carried out by means of a specific measure, but in the absence of specific measures, nothing prevents to maintain or adopt national provisions, provided that they are in accordance with the provisions of the Treaty establishing the European Community, as provided for in Article 6 thereof.

Annex I to the Regulation sets out a list of seventeen groups of materials and articles for which specific measures may be introduced, although there are currently only specific measures established at Community level. for plastic materials, regenerated cellulose films and ceramic objects, which means that Member States may maintain or adopt national provisions for the remaining fourteen groups of materials and articles.

The Resolution of 4 November 1982, by the Under-Secretary for Health, approving the positive list of substances intended for the manufacture of macromolecular compounds, the list of maximum migrations in tests for the disposal of some of them, the purity conditions for colouring matters used in the same products and the list of polymeric materials suitable for the manufacture of packaging and other utensils which may be in contact with food and food products, is a national provision applicable to the groups of the Annex I to the Regulation consisting of polymeric materials such as adhesives, rubber, ion exchange resins, silicones, waxes and varnishes and coatings.

These materials are very used today, mainly the varnishes and coatings that are used inside containers, tanks, etc., so it is necessary to update the resolution, whose only modification is produced by the Order of 3 July 1985 amending the positive list of substances intended for the manufacture of macromolecular compounds and the list of maximum migrations, in tests for disposal, of components of materials Polymer in contact with food. In the light of this, account should be taken of the evaluation work carried out by the Council of Europe in recent years for this type of material, in particular as regards coating on the basis of the varnishes and paints, ion exchange resins, rubbers and silicones, as well as assessments carried out in other European assessment bodies, such as the German Federal Institute for Risk Assessment (BFR) and the French Agency for Food Security (AFSSA).

It is also necessary to delete from the Resolution of 4 November 1982 the provisions applicable to plastic materials as they are regulated by Commission Regulation (EU) No 10/2011 of 14 January 2011, on plastic materials and articles intended to come into contact with food, but taking into account that some of the polymer materials other than plastic materials may also incorporate in their composition monomers, additives and other starting substances included in Regulation (EU) No 10/2011, as a result appropriate to authorize their use.

With regard to media for the production of polymerisation used in plastic materials, Regulation (EU) No 10/2011 provides, in Article 6, that those not listed in its Annex may continue to be used. I, in accordance with national law.

Thus, the Resolution of 4 November 1982 included some supports for the production of polymerisation used in plastic materials, and it is therefore necessary to keep them in force until they are reviewed and establish at Community level. Since their use is essential, either to create the right medium for polymerization or to directly influence the formation of polymers, it is necessary to authorize their use, regardless of whether these supports are not intentionally intended to remain in the final product and cannot have a technological effect on it, in contrast to monomers, additives and other starting substances.

On the other hand, and on the basis of the principle of mutual recognition, it is necessary to clarify the situation of permitted substances for the manufacture of polymeric materials intended to come into contact with food products that are legally authorised in other Member States of the European Union, allowing their use with the same restrictions and restrictions as they exist, without prejudice to the responsibility which the food business operators have on the basis of the Community rules.

In short, this royal decree comes to update the list of permitted substances for the manufacture of polymeric materials intended to come into contact with food.

Finally, the provision is adopted with a regulatory range since, according to the Constitutional Court, this royal decree is considered an essential complement to ensure the lowest common denominator. established in national and Community rules which are applicable to regulated matters.

This royal decree has been submitted to the procedure for information on technical standards and regulations and regulations concerning the services of the information society, provided for in Directive 98 /34/EC of the European Parliament and of the Council of European Parliament and the Council of 22 June, as well as Royal Decree 1337/1999 of 31 July, which incorporates this Directive into the Spanish legal order.

In its treatment, the autonomous communities, the sectors affected, the consumer associations have been heard and the Interministerial Commission for Food Management has issued a mandatory report.

In its virtue, on the proposal of the Minister of Health, Social Policy and Equality, with the prior approval of the Minister of the Presidency, in agreement with the Council of State and after deliberation of the Council of Ministers in its June 17, 2011 meeting,

DISPONGO:

Article 1. Object.

This royal decree is intended to approve:

(a) The positive list of monomers, additives and other starting substances authorised for the manufacture of polymeric materials and articles intended to come into contact with foodstuffs.

(b) Their maximum permitted migrations obtained in migration tests and determine the test conditions thereof.

(c) The conditions of identity and purity of colouring matters.

Article 2. Definitions.

For the purposes of this royal decree, it is understood by:

(a) polymeric material: the organic macromolecular compound obtained by polymerisation, polycondensation, polyaddition or other similar process from lower molecular weight molecules or by chemical modification of Natural macromolecules. Other substances or substances may be added to that macromolecular compound, considered additives.

(b) Additive: any substance incorporated in polymers during the processes of synthesis, processing or processing in order to facilitate such processes and/or to conveniently modify the final properties of the finished product. These additives, with the exception of colours, must appear on the corresponding positive lists.

c) Supports for the production of polymerisation: additives used in the process of polymerisation, either for direct intervention in the reaction (polymerisation aids, such as catalysts and initiators) or for creating a suitable medium (auxiliary for the production of polymers, such as suspension agents and pH regulators). These media are not intentionally intended to remain in the finished object nor can they have a technological effect on it.

Article 3. Scope of application.

1. This royal decree applies to the following materials and articles which, in the state of finished products, are intended to come into contact with or contact foodstuffs, and are intended for this purpose:

a) Adhesives.

b) Elastomers and natural and synthetic rubbers.

c) Ionic exchange resins.

d) Siliconas.

e) Barnices and coatings.

(f) Plastic materials in cases where they act as polymerisation production supports not listed in Annex I to Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food.

g) Ceras.

2. This royal decree will not apply to:

(a) Plastic materials and articles, regulated by Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food, with the exception of media production of the polymerisation provided for in paragraph 1 (f) above.

(b) Regenerated cellulose films, regulated by Royal Decree 1413/1994 of 25 June 1994 laying down the technical-health rules on materials and articles of regenerated cellulose film for use food.

Article 4. Positive list of monomers, additives and other starting substances.

Monomers, additives and other starting substances that can be used for the manufacture of polymeric materials and articles are:

(a) those listed in Annex I to this royal decree, with the restrictions of use listed therein.

(b) those listed in Annex I to Regulation (EU) No 10/2011, with the restrictions of use listed therein.

c) substances legally authorised in other Member States of the European Union, in the countries of the European Free Trade Association (EFTA), Contracting Parties to the Agreement on the European Economic Area (EEA), and States which have a customs association agreement with the European Union, with the same restrictions and restrictions as there are, for the same purpose, in accordance with the principle of mutual recognition established by the Treaty of The functioning of the European Union, all without prejudice to the responsibility of the operators of the Food business is based on the provisions of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, the European Food Safety Authority and procedures relating to food safety, in particular in Section 4 of Chapter II on general requirements of food law.

To demonstrate such compliance, appropriate documentation will be available. Such documentation shall be made available to the competent official control authorities if they so request.

(d) the supports for the production of polymerisation, as defined in Article 2 (c).

Article 5. Conditions for the use of supports for the production of polymerisation.

1. The use of supports for the production of polymerisation is possible as long as it is demonstrated:

(a) which are legally authorised in other Member States of the European Union, with the same restrictions and limitations as there are, for that same purpose, in accordance with the principle of mutual recognition, or

b) which were set out in the Resolution of 4 November 1982.

2. By way of derogation from the above paragraph, the use of other supports for the production of polymerisation is possible, provided that the operator can demonstrate compliance with the conditions laid down in Article 2 (c). In order to demonstrate that conformity, as well as its legal authorisation in other EU Member States, appropriate documentation shall be available. Such documentation shall be made available to the competent official control authorities if they so request.

Article 6. Criteria for identity and purity of colouring matters.

The colouring matters used in the manufacture of the polymeric materials in contact with food shall meet the criteria of identity and purity laid down in Annex II to this royal decree.

Article 7. Global and specific migration limit.

1. Materials and articles must not give up their components to foodstuffs in quantities exceeding 10 milligrams of constituents released per square tenths of the food contact surface (mg/dm2).

2. For materials and articles intended to come into contact with food intended for infants and young children, or who are already in contact with them, as defined in Royal Decree 490/1998 of 27 March 1998 on the Technical-Health Regulations Specific to Food Elaborated On The Basis Of Cereals and Food Infants for Infants and Children of Short Age and Royal Decree 867/2008 of 23 May 2008, for which the Technical-Health Regulations are approved specific to infant formulae and follow-on formulae, the overall migration limit shall be as follows: 60 mg/kg food product.

3. Materials and articles shall not give up their constituents to foodstuffs in quantities exceeding the specific migration limits (SML) set out in Annex I, limits which are expressed in mg/kg of food.

4. For substances that do not have a specific migration limit, or any other restriction, a generic specific migration limit of 60 mg/kg. shall apply to them.

Article 8. Expression of the results of the migration tests.

1. The specific migration values shall be expressed in mg/kg, applying the relationship between the actual surface and the volume in the current or intended use.

2. However, this limit shall be expressed in mg/kg by applying a ratio between the surface and the volume of 6 dm² per kg of food, to:

(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 or grams or more than 10 litres.

b) Materials and articles for which it is not possible to calculate the ratio between the surface of such materials and articles and the amount of food product in contact with them.

c) Laminas and films that are not yet in contact with food.

(d) Lamines and films containing less than 500 millilitres or grams or more than 10 litres.

3. The above paragraph shall not apply to materials and articles intended to come into contact with food intended for infants and young children, or who are already in contact with them, as defined in Royal Decree 490/1998 of 27 June 1998. March, and Royal Decree 867/2008, of 23 January.

Article 9. Conditions of the migration tests.

1. The migration tests may be carried out either in foodstuffs or in simulants.

2. The verification of compliance with the migration limits shall be carried out in accordance with Annexes III and V to Regulation (EU) No 10/2011. It may also be carried out by determining the quantity of a substance in the material or the finished object, provided that a relationship has been defined between that quantity and the value of the specific migration of the substance through of appropriate experimentation or through the application of commonly recognised models of dissemination, based on scientific evidence.

To demonstrate the non-compliance of a material or object it will be mandatory to confirm by experimental analysis the estimated migration value.

3. Verification of compliance with the specific migration limits provided for in paragraph 2 shall not be mandatory where it can be demonstrated that the quantity of residual substance in the material or object, even considering the complete migration of that substance does not exceed the specific migration limit.

4. The tests to check whether the migration to the food products is in accordance with the maximum permitted limits shall be carried out under the most extreme conditions of foreseeable duration and temperature of actual use.

Article 10. Food additives and flavourings.

The additives referred to in Article 4 which are also authorised as food additives by Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives, or as flavourings, in accordance with Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties used in food, migrate:

a) To food products in quantities that have a technological effect on the final food product.

(b) to foodstuffs in which their use is authorised as additives or flavourings in quantities exceeding the restrictions laid down in the rules governing food additives, or flavourings, or the provisions laid down in Article 4 of this royal decree, taking into account the one that establishes the greatest restriction.

(c) Food products in which their use as food additives or flavourings is not authorised in quantities exceeding the restrictions laid down in Article 4.

Article 11. Evaluation of the Scientific Committee of the Spanish Food Safety and Nutrition Agency.

The basic materials for the manufacture of polymeric materials not listed in Annex I to this royal decree shall, for approval and inclusion in that Annex, be subject to evaluation by the Scientific Committee of the Spanish Agency for Food Safety and Nutrition with a view to its inclusion in the Agency.

Article 12. Sanctioning regime.

Without prejudice to other provisions which may be applicable, failure to comply with this royal decree may be the subject of an administrative penalty, subject to the instruction of the appropriate file In accordance with the provisions of Royal Decree 1945/1983 of 22 June 1983 governing infringements and penalties in respect of the defence of the consumer and agri-food production and in Title IV of the European Economic and Social Committee, of the Royal Decree of Law 1/2007 of 16 November, approving the recast of the Law General for the Defense of Consumers and Users and other complementary laws.

Single additional disposition. Mutual recognition clause.

The requirements laid down in this royal decree shall not apply to finished materials and articles which are legally manufactured or marketed in accordance with other specifications in the other Member States of the Union. European, or products originating in the countries of the European Free Trade Association (EFTA) which are contracting parties to the Agreement on the European Economic Area (EEA) or States which have a Customs Association Agreement with the European Union.

Single repeal provision. Regulatory repeal.

The Resolution of 4 November 1982 of the Secretariat for Health, which approves the positive list of substances intended for the manufacture of macromolecular compounds, is hereby repealed. maximum in tests for the disposal of some of them, the purity conditions for colouring matters used in the same products and the list of polymeric materials suitable for the manufacture of packaging and other utensils which may be in contact with food and food products, with the exception of waxes and food supports for the production of polymerization.

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. Powers of development.

The Minister for Health, Social Policy and Equality is empowered to make the necessary arrangements for updating and amending the annexes to this royal decree in accordance with the advances of scientific knowledge and technical and to adapt them to the provisions and amendments introduced by the European Union legislation.

Final disposition third. Entry into force.

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

Given in Madrid, on June 17, 2011.

JOHN CARLOS R.

The Minister of Health, Social Policy and Equality,

LEIRE PAJIN IRALA

ANNEX I

Positive list of monomers, additives and other starting substances that can be used in the manufacture of polymeric materials

General Introduction

1. This Annex sets out the list of monomers, additives and other starting substances which may be used in the manufacture of polymeric materials. This list contains:

(a) Substances intended to be subjected to polymerization, including polycondensation, polyaddition or any other similar process, to produce macromolecules.

(b) natural or synthetic macromolecular substances used in the manufacture of modified macromolecules, provided that the monomers or other starting substances necessary for the synthesis of those substances are not included in the the list.

(c) Substances used to modify existing natural or synthetic macromolecular substances.

2. The list does not include the following substances that could be found in the finished product:

a) Substances that might be found in the finished product such as:

i) impurities of the substances used.

ii) Intermediate reaction products.

iii) Decomposition products.

(b) Oligomers and natural or synthetic macromolecular substances as well as their mixtures, if the monomers or starting substances necessary to synthesise them are already included in the list.

c) Mixtures of the authorised substances.

The materials and articles containing the substances referred to in paragraphs (a), (b) and (c) of this paragraph shall comply with the requirements laid down in Article 3 of Regulation (EC) No 1935/2004 of the European Parliament and of the Council. Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80 /590/EEC and 89 /109/EEC.

3. The authorised substances must be of good technical quality as regards the purity criteria.

4. The list contains the following data:

a) Column 1 (Num. Ref.): the EEC reference number of the substance.

b) Column 2 (CAS number): the Chemical Abstracts Service (CAS) registration number.

c) Column 3 (name): the chemical name.

d) Column 4 (Restrictions and/or Specifications): These may include:

i) The specific migration limit (LME).

ii) The maximum allowed amount of substance in the finished material or object (CM).

iii) Any other specifically mentioned restrictions.

iv) Any other type of specifications linked to the substance or polymer.

5. If a substance listed as an isolated compound is also included in a generic name, the restrictions applicable to this substance shall be those for the isolated compound.

6. In case of disagreement between the CAS number and the chemical name, the chemical name shall prevail against the first. If there is a disagreement between the CAS number collected in the EINECS (European Inventory of Existing Chemical Substances) and the CAS record will apply the latter.

7. Column 4 of the table uses a series of abbreviations whose meaning is as follows:

LD = detection limit of the analysis method.

PT = material or finished object.

NCO = isocyanate functional group.

ND = not detectable. For the purposes of this royal decree the expression 'not detectable' means that the substance should not be detected by a validated analytical method which will detect it with the indicated limit of detection (LD). If there is no such method at the time of the analysis, an analytical method with due characteristics may be used for the detection limit, pending the development of a validated method.

CM = Maximum amount allowed of "residual" substance in the material or object. For the purposes of this royal decree, the quantity of substance in the material or object shall be determined by a validated method of analysis. In the absence of such a method, an analytical method that has the appropriate sensitivity to determine in a reliable and accurate manner the specified limit could be used while a validated method is developed.

CM (T) = maximum allowed amount of "residual" substance in the material or object, expressed as a total of the indicated groups or substances; for the purposes of this royal decree, the quantity of the substance in the material or object is determine by a validated analytical method; if such a method does not exist for the time being, an analytical method may be used which has the necessary sensitivity to reliably determine the specified limit, pending the preparation of a method validated.

LME = Specific migration limit in food or in food simulants, unless otherwise stated; for the purposes of this royal decree, the specific migration of the substance will be determined by an analytical method. validated; if such method does not exist for the time being, an analytical method may be used which has the necessary sensitivity to reliably determine the specified limit, pending the preparation of a validated method.

SML (T) = Specific migration limit in food or in food simulants, expressed as a total of the indicated groups or substances; for the purposes of this royal decree, the specific migration of the substances will be determined by a validated analytical method; if such a method does not exist for the time being, an analytical method may be used which has the necessary sensitivity to reliably determine the specified limit, pending the preparation of a validated method.

Part A. Base materials for the manufacture of silicones

1. Silicone oils:

Linear or branched and/or cyclic organopolysiloxanes with methyl groups linked to the silicon atoms, which may be partially substituted by n-alkyl groups (C₂-C₃₂), phenyl and/or hydroxyl, and their Condensation products with polyethylene glycol and/or polypropylene glycol.

Linear or branched organopolysiloxanes mentioned in the previous paragraph with the addition of up to 5% of hydrogen and/or alkoxyl groups (C₂-C₄) and/or carboalkoxyalkyl (-(CH₂)_2-17-CO-O-(CH₂)_0-17CH₃) and/or hydroxyalkyl linked to the silicon atom.

2. Silicone resins:

Linear or branched organopolysiloxanes with methyl and/or n-alkyl groups (C₂-C₃₂), and/or phenyl, and/or vinyl, and/or hydroxyl, and/or alkoxyl (C₁-C₄), and/or hydrogen, and/or carboalkoxyalkyl (-(CH₂)_2-17-CO-O-(CH₂)_0-17CH₃), and/or hydroxyalkyl (C₁-C₃) linked to the silicon atom and its condensation products with polyethylene and/or polypropylene glycol, alone or in combination with polycondensation products (esters) of: acid isophthalic, terephthalic acid, ethylene glycol, trimethylol propane, bisphenol A, glycerol or pentaerythritol.

3. Silicone elastomers:

Organopolysiloxanes of paragraph 1.

Organopolysiloxanes with vinyl groups attached to the silicon atom.

Addition products of trivinylcyclohexane and α, ω-dihydrogen-polyhydrogenmethyldimethyl-siloxanes, max. 10%.

1-Dodecene, max. 20%.

Polymers of polydimethyl-siloxanes and -silicones, terminated in 3-aminopropyl groups, with 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane (1).

Polymers of polydimethyl-siloxanes and -silicones, terminated in 3-aminopropyl groups, with bis (4-isocyanatocyclohexyl) methane (2).

(1) They must comply with the restrictions and/or specifications laid down in Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with foods for 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane and 1-amino-3-aminomethyl-3,5,5-trimethylcyclohexane substances.

(2) They must comply with the restrictions and/or specifications laid down in Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food for Bis (4-isocyanatocyclohexyl) methane and bis (4-aminocyclohexyl) methane substances.

Part B. Other components for the manufacture of materials in contact with food in the scope of this royal decree

1. Definitive list of monomers, additives and other starting substances:

Num. Ref.

17215

24045

25208

56080

63240

64300

CAS	Chemical name	Restrictions and/or specifications
	25383-99-7	25383-99-7
12980	08015 -74-5	beech nut oil.
12983/1	-
13250		13250		13250		13250		00101-77-9	Bis (4-aminophenyl) methane.	LME= ND (LD=0.01mg/kg).
13520	00116-37-0	2,2-Bis (4-hydroxyphenyl) propane bis (2-hydroxypropyl) ether.	LME= 0,05 mg/kg (for use in the manufacture of adhesives only)
13845	00075-65-0	Terc-butyl alcohol.
14445	061789-44-4	fatty acids from oil castor.
14450/1	-	fatty acids from the castor oil, dehydrated.
14453	061790-39-4	castor oil fatty acids, hydrogenated.
14470	008001-78-3	hydrogenated castor oil.
	14505	09004-35-7	Cellulose acetate.
14508	09004-36-8	cellulose Acetobutyrate.
14512	09004-39-1	Acetopropionate cellulose.
14587	001204-28-0	LME= 0.05 mg/kg (as chloride, determined as trimelitic acid).
14685	08001-31-8	Coconut oil.
	14693	08001-30-7	Corn Oil.
	14695/1	-	Fatty Acids from Corn Oil.
14698	8001-29-4	Cotton seed oil.
14700/1	-	Cotton seed oil fatty acids.
15780	00111-90-0	Eter Diethylene glycol monoethyl.	LME (T) = 3 mg/kg (Group formed by 15780, 16993, 16996, 17002, 48030, 48050, and 53765)
16925	09004-57-3	Etilcellulose.
16993	00111-76-2	monobutyl Eter diethylene glycol.	LME (T) = 3 mg/kg (Group consisting of 15780, 16993, 16996, 17002, 48030, 48050, and 53765)
16996	00110-80-5	ethylene glycol monoethyl ether.	LME (T) = 3 mg/kg (15780, 16993, 16996, 17002, 48030, 48050, and 53765)
17002	00109-86-4	ethylene glycol monomethyl Eter.	LME (T) = 3 mg/kg (Group formed by 15780, 16993, 16996, 17002, 48030, 48050, and 53765)
17175	68938-15 -8	Coconut fatty acids, hydrogenated.
	Sunflower oil fatty acids.
17245	08016-13-5	Fish oil.
17247/1	-	fatty acids from oil fish.
17275	00064-18-6	Acid formic.
18115	31566-31-1	glycerol Monostearate.
18124	008016-24-8	Hemp seed oil.
18126/1	-	Hemp seed oil fatty acids.
18455 18457 (for combined monomers)	107-46-0 (hexamethyldisiloxane) 999-97-3	Silicone Dioxide (SiOx) Coating Formed by hexamethyldisiloxane and hexamethyldisilazane monomers.	LME= 0.05 mg/kg (measured as hexamethyldisiloxane) For use only as a surface treatment agent on PET.
18900	00106-14-9	Acid 12-hydroxystearic.
19532	08001-26-1	Linseed Oil.
19534/1	-	Flax Seed Oil Fatty Acids.
19972	00087-78-5	Mannitol.
21827	00078-93-3	Metil ethyl ketone.	LME= 5 mg/kg.
22190	002163-42-0	2-Methyl-1,3-propanediol.	LME= 5 mg/kg.
22333	000079-11-8	Monochloroacetic acid.	LME= 0.05 mg/kg.
22766	00143-28-2	oleic alcohol.
22932	001187-93-5	perfluoromethyl Eter perfluorovinil.	LME= 0.05 mg/kg (Only for use as a coating anti-adherent)
23173	01314-56-3	Phosphorus pentoxide.
	23730	08002-11-7	poppy oil.
08016-49-7	Pumpkin seed oil.
24055	00089-05-4	pyromelitic acid.	LME= 0.05 mg/kg.
24260	08001-23-8	Oil cartamo.
24435	08008-74-0	Oil sesame.
24440	09000-59-3	Goma lacquer.
24895	08001-21-6	Sunflower oil.
24905	08002-26-4	Pine oil (tall oil) oil.
25205	00108-88-3	LME= 1.2 mg/kg.
26471-62-5	(T) = 1 mg/kg in PT (expressed as NCO) LME (T) = 0.01 mg/Kg (expressed as NCO)
25573	16938-22-0	2,2,4-Trimethylhexane-1,6-diisocyanate.	CM (T) = 1 mg/kg in PT (expressed as NCO) LME (T) = 0.01 mg/Kg (expressed as NCO).
25574	15646-96-5	2,4,4-Trimethylhexane-1,6-diisocyanate.	CM (T) = 1 mg/kg in PT (expressed as NCO) SML (T) = 0.01 mg/Kg (expressed as NCO)
26340	08024-09-7	Nogal nut oil.
26345/1	-	Nogal nut oil fatty acids.
26370	01330-20-7	xylene.	LME (T) = 1.2 mg/kg, with 95945.
35520	12125-02-9	Ammonium Chloride.
37520	002634-33-5	1,2-Bencysotiazolin-3-one.	LME= 0.5 mg/kg. Only for use in aqueous dispersions and emulsions of polymers at concentrations that do not result in an antimicrobial effect on the surface of the polymer or on the food
43120	08001-78-3	castor oil, hydrogenated.
47520	-	Copolymer dicyclopentadiene-indeno-styrene-alpha-methylstyrene-vinyltoluene-isobutylene, hydrogenated.	LME = 5 mg/kg.
48030	00112-34-5	Diethylene glycol monobutyl ether.	LME (T) = 3 mg/kg (Group consisting of 15780, 16993, 16996, 17002, 48030, 48050, and 53765)
48050	00111-90-0	Diethylene glycol monoethyl ether.	LME (T) = 3 mg/kg (Group consisting of 15780, 16993, 16996, 17002, 48030, 48050, and 53765)
49225	00124-40-3	Dimethylamine.	LME= 0.06 mg/kg.
53765	00111-76-2	ethylene glycol monobutyl Eter.	LME (T) = 3 mg/kg (15780, 16993, 16996, 17002, 48030, 48050, and 53765)
54730/1	-	Fatty Acids Cobalt sales of the resin oil.	LME (T) = 0.05 mg/kg (expressed as cobalt) along with all compounds of cobalt.
56000	025395-31-7	glycerol Diacetate.
025637-84-7	glycerol dioleate.
56320	01323-83-7	glycerol diestearate.
56960	25496-72-4	glycerol Monooleate.
57520	31566-31-1	Monostearate glycerol.
57760	00102-76-1
58240	00555-43-1	Glycerol Tristearate.
59960	07705-08-0	Ferric chloride.
62160	07681-53-0	Sodium Hypophosphite.
62220	10045-89-3	LME = 48 mg/kg (expressed as iron).
08006-54-0	Lanolin.
64160	08001-26-1	Linseed Oil.
01310-65-2	Lithium hydroxide.	LME (T) = 0.6 mg/kg (expressed as lithium) along with all lithium compounds
64400	01345-05-7	Litopon.	Free of soluble barium in water
64560	007786-30-3	Magnesium chloride.
	66620	00075-09-2	Methylene chloride.	LME = 0.05 mg/kg.
66655	00078-93-3	Metil ethyl ketone.	LME = 5 mg/kg.
66725	00108-10-1	Metil isobutyl ketone.	LME = 5 mg/kg.
66950	068441-37-2	Copolymer Alpha-methylstyrene-styrene, hydrogenated.	LME = 5 mg/kg.
66960	068441-38-3	Alpha-methylstyrene-vinyltoluene copolymer, hydrogenated.	LME = 5 mg/kg.
67280	00108-90-7	Monochlorobenzene.	LME = 36 mg/kg.
68070	52270-44-7	Neodecanoate cobalt (II).	LME (T) = 0.05 mg/kg (expressed as cobalt) along with all cobalt compounds.
68140	07697-37-2	nitric acid.
68225	00112-92-5	1-Octadecanol.
68650	06700-85-2	n-Octanoate.	LME (T) = 0.05 mg/kg (expressed as cobalt) along with all cobalt compounds.
68680	16577-52-9	n-Octanoate of lithium.
68690	06535-19-9	manganese n-Octanoate.	LME (T) = 0.6 mg/kg (expressed as (manganese) along with all manganese compounds
71960	03825-26-1	Perfluoroctanoate Ammonium.	Only for use in repeated use items, sintered at high temperatures
77280	09005-02-1	polyethylene glycol Dilaurate.
77360	09005-07-6	Dioleate polyethylene glycol.
77660	-	You are polyethylene glycol of natural fatty acids.
78160	09004-96-0	polyethylene glycol monooleate.
79520	-	polyethylene glycol stearate.
79550	009014-85-1	Polyethylene Glycol 2,4,7,9-tetramethyl-5-decin-4,7-diol, ether.
80160	37349-34-1	Polyglycerol monostearate.
80320	09009-32-9	stearate polyglycerol.
83580/1	08002-13-9
83650	09008-34-8	LME (T) = 0,6 mg/kg body of the resynchronized acid and the colophony acids.	LME (T) (expressed as manganese) along with all manganese compounds.
84420	65997-06-0
85550		85550	85550	85550	Table_table_izq"> 09000-59-3	Goma lacquer.
		-
-	Sodium Aluminium
91185	00057-50-1
	92100
61789-97-7
92430	00109-99-9	= 0.6 mg/kg.
93420	07646-78-8	tin chloride (IV).
93540	00108-88-3	Toluene.	LME = 1.2 mg/kg.
94000	00102-71-6	LME= 0.05 mg/kg (including hydrohydrochloric adduct)
	95680	00121-33-5	Vainillina.
95810	00088-12-0	Vinylpyrrolidone.	LME= ND (LD= 0.01 mg/kg).
95870	-	Wheat protein.
96180	-	Zinc powder.
	96200	55799-16-1	Zinc Hydroxiphosphite.

2. Provisional list of monomers, additives and other starting substances:

The substances which form part of this list correspond to substances listed in lists 7, 8 and 9 of the SCF (Scientific Committee on Food), which do not yet have a favourable assessment, and therefore their use in the The manufacture of polymeric materials is restricted to the fact that their migration is lower than the analytical detection level, with a general level of 0,01 mg/Kg being established. In the event that these conditions cannot be guaranteed, the substance cannot be used. The guarantee of compliance with these conditions must be endorsed by the appropriate documentation, which shall be made available to the competent official control authorities if they so request.

Num. Ref.

68185

00131-11-3

-

CAS	Chemical name
13465	00126-00-1	pentanoic 4,4-bis (4-hydroxyphenyl) Acid.
14185	08015 -80-3	Candela Nut
14520	08001-20-5	tung (or China wood) oil
15735	00111-42-2	Diethanolamine.
16190	00121-69-7	N, N-Dimethylaniline.
17505	00098-00-0	Furfuryl Alcohol (Furfurol).
25105	00112-57-2	Tetraethylentamine.
25520	00112-24-3	25915
	25915		00090-72-2	2,4,6-Tris [(dimethylamino) methyl] phenol.
30350	00141-97-9	Etil Acetetateate.
40640	00098-29-3	4-ter-Butilcatecol.
43760	26172-55-4	5-Chloro-2-methyl-4-isothiazolin-3-one.
51870	34590-94-8	dipropylene glycol monomethyl Eter
60640	00150-39-0	N-hydroxyethyl ethylenediamine triacetic acid and its alkaline salts.
61340	00149-44-0	Sodium salt of hydroximetanosulfinic acid.
64240	08016-11-3	epoxidado.Oxirane linseed oil <6.
66740	00814-78-8	Metil isopropenil ketone (=2-Methyl-2-penten-4-one)
67930	61789-51-3	naphthenic acid cobalt salts.
67946	01336-93-2	naphthenic acid manganese sales.
68175	25154-52-3	68185
	00104-40-5	4-Nonylphenol
68640	07435-02-1	cerium octanoate.
68730	18312-04-4	Octanoate zirconium.
69120	00142-77-8	butyl Oleate.
71120	08012-95-1	paraffin oil.
71200		synthetic paraffin
71280	08002-74-2 63231-60-7	Hydrocarbonated, paraffin, and microcrystalline Ceras.
72135	00092-84-2	Fenothiazine.
75120	00084-66-2	75600
	00131-11-3	Dimethyl phthalate.
76980	24938-37-2	polyethylene glycol Adiduck.
80360	09003-27-4	81120
		Polyterpenes.
81260	-	Partially hydrolyzed polyvinyl acetate (degree of minimum hydrolysis 20% molar)
81280	09002-89-5	Polyvinyl alcohols (in which the viscosity of an aqueous solution at 4% and at 20 ° C is at least 2 centipoises)
88680	08002-23-1	Whale sperm Cera.
93585	00104-15 -4	sulfonic p-toluen acid.
96400	53801-45-9	zirconium Oxide.

ANNEX II

Conditions of identity and purity to be met by colouring matters for use in polymeric materials in contact with food

1. Maximum tolerances for impurities soluble in hydrochloric acid 0,1 N in relation to the colouring agent (mg/kg):

Lead: 100.

Arsenic: 100.

Mercury: 50.

Selenium: 100.

Barium: 100.

Chrome: 1000.

Cadmium: 100.

Antimony: 500.

2. Content in free primary aromatic amines:

The maximum content of free primary aromatic amines, expressed in aniline, shall be at most 500 mg/kg in relation to the colouring matter. This limitation relates only to primary aromatic amines, which do not contain carboxylic or sulfonic groups. In any event, the migration limitations for these substances set out in Annex II to Regulation (EU) No 10/2011 (should not release primary aromatic amines in detectable quantity-LD = 0,01mg/kg of food or food simulant).

3. Carbon black (or smoke black):

Removable toluene content: maximum of 0,1%, determined according to the ISO 6209 method.

UV absorption of cyclohexane extract at 386 nm: < 0.02 AU for a 1 cm cell or < 0.1 AU for a 5 cm cell, determined according to a method of analysis with general recognition.

Benzo (a) pyrene content: maximum of 0.25 mg/kg carbon black.

Maximum level of use of carbon black in the polymer: 2.5% w/w.