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Royal Decree 2207 / 1994, Of 16 November, Which Approves The List Of Permitted Substances For The Manufacture Of Plastic Materials And Articles Intended To Come Into Contact With Foodstuffs And Regulate Certain Test Conditions.

Original Language Title: Real Decreto 2207/1994, de 16 de noviembre, por el que se aprueba la lista de sustancias permitidas para la fabricación de materiales y objetos plásticos destinados a entrar en contacto con los alimentos y se regulan determinadas condiciones de ensayo.

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TEXT

Royal Decree 1425/1988 of 25 November, adopting the Technical-sanitary Regulation for the development, circulation and trade of plastic materials intended for contact with food and food products, incorporated into national legislation the Community Directives concerning materials and containers intended to be in contact with food, and in particular the Council Directive 76/893/EC of 23 November,

The publication of Commission Directive 90/128/EEC of 23 February, which establishes the maximum migrations allowed for monomers and starting substances, the positive list of them, the maximum limit of global migration of plastic materials and objects, and the conditions of testing, made necessary the adaptation of our legislation to the same, and to the previous community directives, related also to the conditions of testing of the materials, the Council of 1872/7E The transfer to our legal system of these provisions was carried out through Royal Decree 211/1992 of 6 March, which approved the list of substances allowed for the manufacture of plastic materials and objects intended to contact food and regulates certain conditions of testing.

Subsequently, Commission Directive 92/39/EEC of 14 May amending Commission Directive 90/128/EEC was incorporated into our legal system by Royal Decree 1769/1993 of 8 October amending Royal Decree 211/1992, which was previously cited.

Finally, Directives 82/711/EEC and 90/128/EEC, mentioned above, have been subject to further modifications, through Commission Directives 93/8/EEC of 15 March, concerning the modification of Council Directive 82/711/EEC, which establishes the basic rules necessary for the verification of the migration of the components of the materials and objects of plastic matter destined to enter into contact with products 90/12

The incorporation of these last two Directives, 93/8/CEE and 93/9/CEE, into our legal system, is carried out through this Royal Decree, which is to repeal the aforementioned Royal Decrees 211/1992 and 1769/1993.

Thus, different modifications are introduced to the current regulations on the conditions of time and temperature of migration tests; the list of monomers and starting substances is modified, adding new substances to section A, modifying the contents of the column "Restrictions" of some of them, deleting others, expanding section B and definitively accepting some substances for incorporation into section A. These modifications are in line, already announced in the current regulations, of progressive deletion of section B of annex II, in order that, as of 1 January 1997, they can only be used, for the manufacture of plastic materials and objects intended to come into contact with food, monomers and other substances listed in section A of annex II, in the terms and with the restrictions specified therein.

On the other hand, the Resolution of the Undersecretariat for Health of 4 November 1982 (“Official State Gazette” of 24), as amended by Order of the Ministry of Health and Consumer Affairs of 3 July 1985 (“Official State Gazette” of 12), regulates plastic materials and objects, as well as the authorization of the monomers and proceeding substances and additives. This Resolution affects other materials not included in the scope of the Royal Decree 1425/1988, so it is necessary to maintain the validity of it, given that Directive 90/128/EEC refers only to monomers and substances of departure, it is necessary to continue applying the Resolution of the Undersecretariat for Health of 4 November 1982, as it refers to the positive list of the substances used as an additive to it. The validity of this Resolution is also reflected in article 6, paragraph 1, of this Royal Decree.

The present provision, which sets out the positive lists of monomers and starting substances, their specific migration limits and the maximum global migration for plastic materials and objects, has been developed.

The present Royal Decree is issued in accordance with article 40.2 and 4 of Law 14/1986 of 25 April, General of Health, and in accordance with article 149.1.16 of the Constitution. The affected sectors have been heard.

By virtue, on the proposal of the Ministers of Health and Consumer Affairs, Industry and Energy, Agriculture, Fisheries and Food and Trade and Tourism, with report of the Inter-Ministerial Commission for Food Management, in accordance with the Council of State and prior deliberation of the Council of Ministers at its meeting on 11 November 1994,

D I S P O N G O :

Article 1. Scope of application.

1. The purpose of this Royal Decree is to adopt the positive list of monomers and substances authorized for the manufacture of plastic materials and objects intended to come into contact with food and food products, their maximum permitted migrations given in evidence of migration, whether global or for a specific constituent and to determine the conditions of the tests of them.

2. This Royal Decree applies to plastic materials and objects included in the scope of application and definitions set out in articles 1 and 2 of the Technical-sanitary Regulation for the development, circulation and trade of plastic materials intended to contact food and food products, approved by Royal Decree 1425/1988 of 25 November.

3. They are excluded from the scope of the present Royal Decree:

(a) Regenerated cellulose films varnished or not varnished.

(b) Elastomers and natural or synthetic rubbers.

(c) Papers and cartons, modified or not, by addition of plastic matter.

(d) Surface coatings obtained from: paraffin waxes, including synthetic paraffin waxes and/or microcrystalline waxes. Mixtures of waxes mentioned in the preceding paragraph, among themselves and/or microcrystalline.

(e) Ionic exchange resins.

Article 2. Limit of global migration.

Plastic materials and objects should not yield their components to food products in quantities exceeding 10 milligrams per square decimeter of material or article surface (mg/dm2) (global migration limit). However, this limit will be 60 milligrams of constituents released per kilogram of food product (mg/kg) in the following cases:

(a) Items that are packaging or comparable to packaging or that can be filled with a capacity not less than 500 milliliters (ml) and not more than 10 liters.

(b) Items that can be filled and whose surface in contact with food products is impossible to calculate.

(c) Caps, shutters, plugs or other similar closing devices.

Article 3. Specific migration limits.

1. The specific migration limits indicated in annex II to this Royal Decree are expressed in mg/Kg. However, such limits are expressed in mg/dm2 in the following cases:

(a) Items that are packaging or comparable to packaging, or that can be filled, with a capacity of less than 500 milliliters (ml) or more than 10 litres.

(b) Lamines, films or other materials that cannot be filled or for which it is impossible to calculate

relation between the surface of such materials and the amount of food product in contact with them.

2. In cases considered in paragraph 1, the limits indicated in annex II, expressed in mg/Kg, shall be divided by 6, as a conventional conversion factor, to be expressed in mg/dm2.

Article 4. Conditions of migration testing.

1. Migration tests can be done either in food products or in simulators.

2. Verification of compliance with migration limits shall be carried out in accordance with annexes I and IV of this Royal Decree.

3. Verification of compliance with the specific migration limits provided for in Article 3 shall not be mandatory, in the event that compliance with the global migration limit set out in Article 2 implies that the specific migration limits are not exceeded.

4. Verification of compliance with the specific migration limits provided for in Article 3 shall not be mandatory, in the event that the amount of residual substance in the material or object, even considering the complete migration of that substance, does not exceed the specific migration limit.

5. Tests to check whether migration to food products conforms to the maximum permitted limits will be carried out under the most foreseeable conditions of duration and temperature in real use.

Article 5. Positive list of monomers and other starting substances.

1. They may only be used for the manufacture of plastic materials and objects, monomers and other starting substances listed in sections A and B of annex II to this Royal Decree, with the restrictions specified therein.

2. The expansion of the list of annex II, section A, may be made, for the inclusion of the substances listed in section B of annex II, in accordance with the criteria set out in annex III, or of non-Annex II substances.

3. For the purposes of this Royal Decree, the positive lists of monomers and other starting substances contained in sections A and B of annex II cannot be considered until the adoption of their specific legislation, as positive lists of such substances, used in the manufacture of:

(a) Surface coatings obtained from resinous or polymerized products in liquid, dust or dispersal form, such as varnishes, lacquers, paints, etc.

(b) Silicones.

(c) Epoxydic resins.

(d) Products obtained by bacterial fermentation.

(e) Adhesives and adhesives.

(f) Printing ink.

Article 6. Positive list of additives.

1. The positive list of additives, not of monomers or starting substances, for the manufacture of plastic materials and objects, the list of maximum migrations in evidence of the assignment of some additives, the conditions of purity for the coloring materials used in the same products and the list of the plastic materials suitable for the manufacture of containers and other utensils that may be in contact with the products established in this field

2. To the values admitted for the specific migrations of additives in which the functional duality of monomer or substance of departure and additive can be presented, the criteria established in this Royal Decree shall apply.

3. All colouring materials used for the manufacture or processing of plastic materials and objects are authorized to comply with article 7, paragraph 7.5, of the Technical and Health Regulations adopted by Royal Decree 1425/1988 of 25 November. Such materials shall not be on the positive list of substances permitted for the manufacture of plastic materials and objects.

Article 7. Declaration for marketing.

Except for those plastic materials and objects which, by their nature, it is obvious to use in contact with food or food products and therefore must meet the legal requirements established for them, the remaining plastic materials and objects, when they are intended to contact food or food products, in the commercialization phases other than those of retail sale, must be accompanied by a written statement that certifies their conformity with the legal provisions.

Single additional provision. Basic policy.

The present Royal Decree is issued under article 149.1.16.a of the Constitution in accordance with article 40.2 and 4 of Law 14/1986 of 25 April, General of Health, in relation to article 2 of the same legal body.

Single transitional provision. Transitional authorization for the trade and use of certain materials and objects.

Until 31 March 1996, trade and use of plastic materials and objects are authorized to contact food products which, without adapting to the provisions of this Royal Decree, are made in accordance with Royal Decree 1769/1993 of 8 October.

Unique derogatory provision. Policy repeal.

Without prejudice to the provisions of the single transitional provision, any provisions of equal or lower rank are repealed as opposed to the provisions of this Royal Decree, and in particular the Royal Decrees 211/1992 of 6 March and 1769/1993 of 8 October, except as provided for in the sole transitional provision of the latter.

Final provision first. Faculty of development.

The Ministers of Health and Consumer Affairs, Industry and Energy, Agriculture, Fisheries and Food and Trade and Tourism are authorized to issue within their respective competence the necessary provisions for the development of this Royal Decree, as well as for the updating of its annexes, where necessary to adapt them to the provisions of the European Union.

Final provision second. Entry into force.

This Royal Decree will enter into force within ten days of its publication in the “Official Gazette of the State”.

Given in Madrid to 16 November 1994.

JUAN CARLOS R.

The Minister of the Presidency,

ALFREDO PEREZ RUBALCABA

Annex I

Additional provisions applicable to control compliance with migration limits

General provisions

1. When the results of the migration tests specified in Annex IV are presented, it must be accepted in a conventional manner that the specific weight of all the simulators is 1g/cm3. Thus, milligrams of substance or substances migrated by litre of simulant (mg/l), shall numerically correspond to milligrams of substances or substances released by kilogram of simulant and, according to the conditions set out in annex IV, to milligrams of substances or substances released by kilogram of food product.

2. When the migration tests are carried out on samples taken from the material or object or on purpose-made samples and the amounts in food or simulating products in contact with the sample are different from that used in the actual conditions in which the material or object is used, the results obtained must be corrected using the following formula:

M = ((m . a2)/(a1 . q) x 1000

Where:

M = migration in mg/kg.

m = shall be the mass expressed in mg of substance released by the sample and determined in the migration test.

a1 = will be the surface expressed in dm2 of the sample in contact with food or simulators in the migration test.

a2 = shall be the surface expressed in dm2 of the material or object in the actual conditions of use.

q = will be the amount expressed in grams of food in contact with the material or object in the actual conditions of use.

3. The determination of migration shall be carried out on the material or object or, if this is not possible, using samples taken from the material or object or, where appropriate, representative samples of such material or object.

The sample will contact the food product or the simulator in a manner equivalent to the actual contact conditions. For this purpose, the test will be carried out in such a way that only those parts of the samples intended to contact the food products in the actual use contact with the food product or the simulator. This condition is particularly important in the case of materials or objects that are composed of various layers, for closures, etc.

Migration tests carried out on hoods, shutters, plugs or similar devices used with closure should be carried out by putting these objects in contact with the containers to which they are intended in such a way that they correspond to the normal or foreseeable conditions of use.

In all these cases, it will be lawful to demonstrate compliance with migration limits through more severe evidence.

4. In accordance with the provisions of Article 4 of this Royal Decree, the sample of the material or object shall be placed in contact with the appropriate food product or simulator for a period of time and at a temperature chosen in relation to the contact conditions in the actual use, in accordance with the rules set out in Annex IV. At the end of the prescribed time, the analytical determination of the total amount of substance (global migration) and/or the specific amount of one or more substances (specific migration) released by the sample will be carried out on the food product or the simulant.

5. When a material or object is intended to repeatedly contact food products, the migration test or testing should be carried out three times on the same sample, according to the conditions set out in Annex IV using another sample of food or simulator in each test. The conformity of such material or object with the limits shall be controlled on the basis of the level of migration in the third test. However, if there is a conclusive evidence that the level of migration does not increase in the second and third tests and if the limit or limits of migration are not exceeded in the first test, the following will not be necessary.

Related special provisions

with global migration

6. If the aqueous simulants specified in Annex IV are used, the determination of the total amount is released by the sample can be carried out by evaporation of the simulant and determination of the waste weight.

If the olive oil is used or any of the substitutes, the following procedure can be followed: the sample or object will be weighed before and after contact with the simulator. The amount of the sample absorbed will be extracted and determined quantitatively. The amount of simulant found will be subtracted from the weight of the measured sample after contact with the simulator. The difference between the corrected initial and final weights will represent the global migration of the sample examined.

When a material or object is intended to enter into repeated contact with food products and is technically impossible to carry out the test described in paragraph 5, modifications of this test may be accepted in order to determine the level of migration taking place during the third test. One of these possible modifications is described below: the test will be carried out in three identical samples of the material or object. One of these will be subject to appropriate testing and global migration will be determined (M1); the second and third samples will be subject to the same temperature conditions, but the contact periods will be two and three times higher than specified respectively and global migration will be determined in each case (M2 and M3, respectively).

The material or object shall be deemed to be consistent provided that M1 or M3 do not exceed the global migration limit.

7. A material or object that exceeds the limit of global migration in amounts not exceeding the analytical tolerance mentioned below should be considered in accordance with this Royal Decree.

The following analytical tolerances are supported:

(a) 20 mg/kg or 3 mg/dm2 in migration tests using olive oil or substitute products.

(b) 6 mg/kg or 1 mg/dm2 in the migration tests used by the other simulators referred to in Annex IV.

8. No migration tests will be conducted using olive oil or substitute products to verify compliance with the global migration limit where it has been proven conclusively that the specified analytical method is technically inadequate.

In such cases, a specific migration limit of 60 mg/Kg or 10 mg/dm2 will apply for substances that do not have specific migration limits or other restrictions on the list listed in Annex II. The sum of all specific migrations will not exceed, however, the global migration limit.

Annex II

List of monomers and other substances authorized for use in the manufacture of plastic materials and objects

General Introduction

1. This annex sets out the list of monomers or other starting substances. This list contains:

Substances aimed at polymerization, including polycondensation, polyaddition or any other similar process, to produce macromolecules;

Natural or synthetic macromolecule substances used in the manufacture of modified macromolecules, provided that monomers or other starting substances necessary for the synthesis of those are not included in the list; substances used to modify existing natural or synthetic macromolecule substances.

2. The list does not include salts (double salts and acid salts) of aluminum, amonium, calcium, iron, magnesium, potassium, sodium and zinc of acids, phenols or alcohols which are also authorized; however, names containing the word ... acid(s), salt(s) appear in the list, in case the corresponding(s) free acid(s). In such cases the meaning of the term "sales" is "sales of aluminum, ammonia, calcium, iron, magnesium, potassium, sodium and zinc".

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

(a) Substances that could be found in the finished product as:

1.o Impurities of the substances used.

2. Intermediate reaction products.

3.o Decomposition products.

(b) Natural or synthetic macromolecule oligomers and substances as well as their mixtures, if the monomers or starting substances necessary to synthesize them are already included in the list.

(c) Mixtures of authorized substances.

Materials and objects containing the substances referred to in paragraphs (b) and (c) shall meet the requirements of Royal Decree 1425/1988.

4. Authorized substances should be of good technical quality.

5. The list contains the following data:

(a) Column 1 (ReF/ME number): the EEC reference number of the packaging material substance from the list.

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

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

(d) Column 4 (restrictions). These may include:

1.o The specific migration limit (LME).

2. Maximum permitted quantity of "residual" substance in the material or object (QM).

3.o Any other specifically mentioned restriction.

6. If a substance that appears on the list as an isolated compound is also included in a generic name, the restrictions applicable to this substance will be the corresponding to the isolated compound.

7. In case of disagreement between the CAS number and the chemical name, the latter will prevail against the first. If there is disagreement between the CAS number collected in the EINECS and the CAS registry will apply the latter.

8. A series of abbreviations are used in column 4 of the table, the meaning of which is as follows:

(a) LD = Screening limit for the analysis method.

(b) PT = Material or finished object.

(c) SA = Food simulator.

(d) NCO = Associated functional group.

(e) ND = Not detectable.

For the purposes of this Royal Decree, the term "not detectable" means that the substance should not be detected by a validated analytical method, which possesses a detection limit according to what is required by its specific restriction. If there is no such method at the time of the analysis, a reliable and reproducible analytical method may be used that possesses the detection limit required by its specific restriction, pending the development of a validated method.

(f) QM = Maximum permitted quantity of "residual" substance in the material or object.

(g) QM(T) = Maximum permitted quantity of "residual" substance in the material or object, expressed as a total of the groups or substances indicated. "QM(T) means that the maximum permitted quantity of "residual" substance in the material or object will be determined by an analytical method validated in the specified limit. If such a method does not exist at this time, an analytical method may be used that possesses the sensitivity necessary to determine the limit specified in a reliable manner pending the development of a validated method.

(h) LME = Limit of specific migrations in food or food simulators, unless otherwise indicated. For the purposes of this Royal Decree "LME" means that the specific migration of the substance will be determined by a validated analytical method that possesses a detection limit according to what is required by its LME. If there is no such method at the time of the analysis, a reliable and reproducible analytical method may be used that possesses the sensitivity required by your LME, pending the development of a validated method.

(i) LME(T) = Specific migration limit in food or food simulators, expressed as such of the groups or substances indicated. "LME(T)" means that the specific migration limit of substances will be determined by an analytical method validated on the specified limit. If such a method does not exist at the moment, an analytical method may be used that possesses the necessary sensitivity to determine the specified limit in a reliable manner, pending the development of a validated method.

SECTION A

Authorized list of monomers and other starting substances

N.o

pm/ref

(1)

/ N.o CAS

(2)

/ Name

(3)

/ Restrictions

(4) 10030

/ 000514-10-3

Abiotic acid.

10060

/ 000075-07-0

/ Actaldehyde.

10090

000064-19-7

/ Acetic acid.

10120

/ 000108-05-4

/ Vinyl acetate.

/ LME = 12 mg/kg.

10150

/ 000108-24-7

/ Acetic anhydride.

10210

/ 000074-86-2

/ Acetylene.

10630

/ 000079-06-1

/ Acrilamide.

/ LME = ND (LD = 0.01 mg/Kg).

10690

/ 000079-10-7

/ Acrylic acid.

10750

/ 002495-35-4

/ Beast acrylate.

10780

/ 000141-32-2

/ N-butyl acrylate.

10810

/ 002998-08-5

/ Sec-butyl acrylate.

10840

/ 001663-39-4

/ Ter-butyl acrylate.

11470

/ 000140-88-5

/ Ethyl acrylate.

000818-61-1

/ Hydroxyethyl acrylate.

/ See “Monocrilato de dieilenglicol”.

11590

/ 00106-63-8

/ Isobutyl acrylate.

11680

/ 000689-12-3

/ Isopropyl acrylate.

11710

/ 000096-33-3

/ Methyl acrylate.

11830

/ 000818-61-1

/ Ethylene glycol monocrilate.

11890

/ 002499-59-4

/ n-octile acrylate.

11980

/ 000925-60-0

/ Propyl acrylate.

12100

/ 000107-13-1

/ Acrilonitrile.

/ LME = non-detectable (LD = 0.020 mg/Kg, analytical tolerance included).

12130

/ 000124-04-9

/ Acid adipic.

12280

/ 002035-75-8

/ Adipic anhydride.

12310

/

/ Albumin.

12340

/

/ Albumin coagulated by formaldehyde.

12375

/

/ Monoalcohols alphatic saturated linear, primary (C4-C22).

12670

/ 002855-13-2

/ 1-amino-3-amonomethyl-3,5,5-trimethyl cyclehexane.

/ LME = 6 mg/Kg.

12788

/ 002432-99-7

/ Acid 11-aminoundecanoic.

/ LME = 5 mg/kg.

12820

/ 000123-99-9

/ Acelaic acid.

12970

/ 004196-95-6

/ Azelaic anhydrate.

13000

/ 001477-55-0

/ 1.3-bencenodimetanamina.

/ LME = 0.05 mg/Kg.

13090

/ 000065-85-0

/ Benzoic acid.

13150

/ 000100-51-6

/ Bench alcohol.

000111-46-6

/ Eter bis (2-hydroxyethyl).

/ See «Dietilenglicol».

000077-99-6

/ 2,2-Bis (hydroxymethyl)-1-butanol.

/ See “1,1,1-trimethylolpropane”.

13390

/ 000105-08-8

/ 1.4-bis (hydroxymethyl) cyclehexane.

13480

/ 000080-05-7

/ 2.2-bis (4-hydroxyphenyl) propane.

/ LME = 3 mg/Kg.

13510

/ 001675-54-3

/ Eter bis (2.3-epoxypilic) of.

/ QM = 1 mg/Kg in PT or.

2,2-bis (4-hydroxyphenyl) propane.

/ LME = non-detectable (LD = 0.020 mg/Kg, analytical tolerance included).

000110-98-5

/ Eter bis (hydroxypropylic).

/ See «Dipropilenglicol».

005124-30-1

/ Bis (4-issocianatociclohexil) methane.

/ See "4,4" diissocianate of diciclohexilmethane.

13530

/ 038103-06-9

/ Bis (phalic anhydride) 2,2-bis (4-hydroxyphenyl) propane.

/ LME = 0.05 mg/Kg.

13600

/ 047465-97-4

3.3-bis (3-methyl-4-hydroxyphenyl) 2-indolinone.

000080-05-7

/ Bisphenol A.

/ See "2,2-bis (4-hydroxyphenyl) propane.

001675-54-3

/ Eter bis (2.3-epoxypropylic) of bisphenol A.

/ See “Eter bis (2.3 epoxypropylic) 2,2-bis (4-hydroxyphenyl) propane”.

13614

/ 038103-06-9

Bis (phalic ahydride) of bisphenol A.

/ See 13530.

13630

/ 000106-99-0

Butadieno.

/ QM = 1 mg/Kg in PT or LME = non-detectable (LD = 0.02 mg/Kg, analytical tolerance included).

13690

/ 000107-88-0

/ 1.3-Butanodiol.

13840

/ 000071-36-3

/ 1-Butanol.

13870

/ 000106-98-9

/ 1-Butene.

13900

/ 000107-01-7

/ 2-Buteno.

14110

/ 000123-72-8

Butiraldehído.

14140

/ 000107-92-6

/ Butic acid.

14170

/ 000106-31-0

/ Butic anhydrate.

14200

/ 000105-60-2

/ Caprolactama.

/ LME(T) = 15 mg/Kg.

14230

/ 002123-24-2

/ Caprolactama, sodium salt.

/ LME(T) = 15 mg/Kg (expressed as caprolactama).

14320

/ 000124-07-2

/ Acido caprílico.

14350

/ 000630-08-0

/ Carbon monoxide.

14380

/ 000075-44-5

/ Carbonyl chloride.

/ QM = 1 mg/Kg in PT.

14410

/ 008001-79-4

/ Ricino acid (food quality).

14500

/ 009004-34-6

/ Jealous.

14530

/ 007782-50-5

/ Clone.

000106-89-8

/ 1-Cloro-2,3-epoxypropane.

/ See "Epiclorhidrina".

14680

/ 000077-92-9

/ Citric acid.

14710

/ 000108-39-4

/ m-Cresol.

14740

/ 000095-48-7

o-Cresol.

14770

/ 00106-44-5

/ p-Cresol.

000105-08-8

/ 1.4-Ciclohexanodimetanol.

/ See “1,4-bis (hydroxymethyl) cyclehexane”.

14950

/ 003173-53-3

/ Cyclohexile Isocianate.

/ QM(T) = 1 mg/Kg in PT (expressed as NCO).

15095

/ 000334-48-5

/ Deanic acid.

15100

/ 000112-30-1

/ 1-Dean.

000107-153

/ 1.2-Diaminoethane.

/ See "Ethylenediamine".

000124-09-4

/ 1.6-Diaminohexane.

/ See "Hexametilendiamine".

15250

/ 000110-60-1

/ 1.4-Diaminobutan.

15565

/ 000106-46-7

/ 1.4-Diachlorobenzene.

/ LME = 12 mg/Kg.

15700

/ 005124-30-1

/ 4,4-Diissocyanate of diciclohexilmethane.

/ QM(T) = 1 mg/Kg in PT (expressed as NCO).

15760

/ 000111-46-6

/ Dietilenglicol.

/ LME(T) = 30 mg/Kg, only or with ethylene glycol.

15790

/ 000111-40-0

/ Dietilentriamina.

/ LME = 5 mg/Kg.

15820

/ 000345-92-6

4.4--Difluorbenzofenone.

/ LME = 0.05 mg/Kg.

15880

/ 000120-80-9

/ 1.2-Dihidroxibenceno.

/ LME = 6 mg/Kg.

15910

/ 000108-46-3

/ 1.3-Dihidroxibenceno.

/ LME = 2.4 mg/Kg.

15940

/ 000123-31-9

/ 1.4-Dihidroxibenceno.

/ LME = 0.6 mg/Kg.

15970

/ 000611-99-4

4.4"Dihydroxybenzofenone.

/ LME = 6 mg/Kg.

16600

/ 000092-88-6

4.4"Dihydroxybiphenyl.

/ LME = 6 mg/Kg.

16150

/ 000108-01-0

/ Dimetilaminoetanol.

/ LME = 18 mg/Kg.

16240

/ 000091-97-4

4.4"Diissociation of 3.3-methyl fenilo.

/ QM(T) = 1 mg/Kg in PT (expressed as NCO).

16480

/ 000126-58-9

/ Dipentaeritritol.

16570

/ 004128-73-8

4.4"Diissociation of the diphenyl ether.

/ QM(T) = 1 mg/Kg in PT (expressed as NCO).

16600

/ 005873-54-1

/ 2.4"Diissociation of diphenylmethane.

/ QM(T) = 1 mg/Kg in PT (expressed as NCO).

16630

/ 000101-68-8

4.4"Diissociation of diphenylmethane.

/ QM(T) = 1 mg/Kg in PT (expressed as NCO).

16660

/ 000110-98-5

/ Dipropilenglicol.

16750

/ 000106-89-8

/ Epiclorhydrine.

/ QM = 1 mg/Kg.

16780

000064-17-5

/ Etanol.

16950

/ 000074-85-1

/ Ethylene.

16960

/ 000107-15-3

/ Ethylenediamine.

/ LME = 12 mg/Kg.

16990

/ 000107-21-1

/ Etilenglicol.

/ LME(T) = 30 mg/Kg, only or with dieylene glycol.

17005

/ 000151-56-4

/ Etilenimina.

/ LME = ND (LD = 0.01 mg/Kg).

17020

000075-21-8

/ Ethylene oxide.

/ QM = 1 mg/Kg in PT.

17160

/ 000097-53-0

/ Eugenol.

/ LME = 0.01 mg/Kg.

17170

/ 061788-47-4

/ Fatty acids of coconut oil.

17200

/ 068308-53-2

/ Fatty acids of soy oil.

17230

/ 061790-12-3

/ Heavy oil fatty acids.

17260

/ 000050-00-0

/ Formaldehído.

/ LME = 15 mg/Kg.

17290

/ 000110-17-8

/ Acido fumárico.

17530

/ 000050-99-7

/ Glucose.

18010

/ 000110-94-1

/ Glutaric acid.

18070

/ 000108-55-4

/ Glutaric anhydrate.

18100

/ 000056-81-5

/ Glicerol.

18250

/ 000115-28-6

/ Acido hexachloroendomethylentetrahydrophtalic.

/ LME = ND (LD = 0.01 mg/Kg).

18280

/ 000115-27-5

/ Hexachloroendomethylthophtalic anhydride.

/ LM = ND (LD = 0.01 mg/Kg).

18310

/ 036653-82-4

/ 1-Hexadecanol.

18430

/ 000116-15-4

/ Hexafluorpropylene.

/ LME = ND (LD = 0.01 mg/Kg).

18460

/ 000124-09-4

/ Hexametilendiamine.

/ LME = 2.4 mg/Kg.

18640

/ 000822-06-0

/ Hexamethylene diissocyanate.

/ QM(T) = 1 mg/Kg in PT (expressed as NCO).

18670

/ 000100-97-0

/ Hexametilentetramine.

/ LME(T) = 15 mg/Kg (expressed as formaldehyde).

000123-31-9

/ Hidroquinone.

/ See “1,4-Dihidroxibenceno”.

18880

/ 000099-96-7

/ Acido p-hydroxybenzoic.

19000

/ 000115-11-7

/ Isobuteno.

19210

/ 001459-93-4

Isoftalato of dimethyl.

/ LME = 0.05 mg/Kg.

19470

/ 000143-07-7

/ Lyric acid.

19510

/ 011132-73-3

/ Lignocellulose.

19540

/ 000110-16-7

/ Male acid.

/ LME(T) = 30 mg/Kg.

19960

/ 000108-31-6

- I'm sorry.

/ LME(T) = 30 mg/Kg (expressed as maleic acid).

000108-78-1

/ Melamina.

/ See “2,4,6-Triamino-1,3,5-triazina”.

20020

/ 000079-41-4

/ Metacrylic acid.

20080

/ 002495-37-6

/ Beast metacrilate.

20110

/ 000097-88-1

/ Butyl metacrilate.

20140

/ 002998-18-7

/ Sec-butyl metacrilate.

20170

/ 000585-07-9

/ Ter-butyl metacrilate.

20890

/ 000097-63-2

/ Ethyl metacrilate.

210

/ 000097-86-9

/ Isobutyl metacrilate.

21100

/ 004655-34-9

/ Isopropyl metacrilate.

21130

/ 000080-62-6

/ Methyl metacrilate.

21190

/ 000868-77-9

/ Ethylene glycol monometacrylate.

21280

/ 002177-70-0

/ Fenyl metacrilate.

21340

/ 002210-28-8

/ Propyl metacrilate.

21460

/ 000760-93-0

/ Metacrylic anhydride.

21490

/ 000126-98-7

/ Metacrilonitrile.

/ LME = non-detectable (LD = 0.020 mg/Kg, analytical tolerance included).

21550

/ 000067-56-1

/ Methanol.

21940

/ 000924-42-5

/ N-Methylolacrilamide.

/ LME = ND (LD = 0.01 mg/Kg).

22150

/ 000691-37-2

4-Methyl-1-penthen.

/ LME = 0.02 mg/Kg.

22350

/ 000544-63-8

/ Mystic acid.

22390

/ 000840-65-3

/ 2,6-Naftalenodicarboxylate of dimethyl.

/ LME = 0.05 mg/Kg.

22420

/ 003137-72-6

/ 1.5-Diissocianate of nafthylene.

/ QM(T) = 1 mg/Kg in PT (expressed as NCO).

22450

/ 009004-70-0

/ Nitrocellulose.

22480

/ 000143-08-8

/ 1-Nonanol.

22570

/ 000112-96-9

/ Isocianato of octadecyl.

/ QM(T) = 1 mg/Kg in PT (expressed in NCO).

22600

/ 000111-87-5

/ 1-Octanol.

22660

/ 000111-66-0

/ 1-Octeno.

/ LME = 15 mg/Kg.

22763

/ 000112-80-1

/ Oleic acid.

22780

/ 000057-10-3

/ Acido palmatico.

22840

/ 000115-77-5

/ Pentaeritritol.

22870

/ 000071-41-0

/ 1-Pentanol.

22960

/ 000108-95-2

/ Fenol.

23050

/ 000108-45-2

/ 1.3-Fenilendiamine.

/ QM = 1 mg/Kg in PT.

000075-44-5

/ Fosgeno.

/ See “Carbyl Chloride”.

23170

/ 007664-38-2

/ Phosphoric acid.

Phatalic acid.

/ See “Terephalic acid”.

23200

/ 000088-99-3

/ Acido o-ftálico.

23230

/ 000131-17-9

/ Dysatile Fthalate.

/ LME = ND (LD = 0.01 mg/Kg).

23380

/ 00085-44-9

/ Phtalic anhydrate.

23470

/ 000080-56-8

/ Alpha-Pinene.

23500

/ 000127-91-3

/ Beta-Pineno.

23590

/ 025322-68-3

/ Polyethylene glycol.

23650

/ 025322-69-4

/ Polypropilenglicol (molecular weight above 400).

23740

/ 000057-55-6

/ 1.2-Propanodiol.

23800

000071-23-8

/ 1-Propanol.

23830

/ 000067-63-0

/ 2-Propanol.

23860

/ 000123-38-6

/ Propionaldehyde.

23890

/ 000079-09-4

/ Propionic acid.

23950

/ 000123-62-6

/ Propionic anhydration.

23980

/ 000115-07-1

/ Propylene.

24010

/ 000075-56-9

/ Propylene oxide.

/ QM = 1 mg/Kg in PT.

000120-80-9

/ Pirocatecol.

/ See “1,2-Dihidroxibenceno”.

24057

/ 000089-32-7

/ Pyromeltic anhydrate.

/ LME = 0.05 mg/Kg (expressed as piromeltic acid).

24070

/ 073138-82-6

/ Resinic acids.

000108-46-3

/ Resorcinol.

/ See “1,3-Dihidroxibenceno”.

24100

/ 008050-09-7

/ Colony.

24130

/ 008050-09-7

/ Goma of colophony.

24160

/ 008052-10-6

/ High oil resin.

24190

/ 009014-63-5

/ Wooden resin.

24250

/ 009006-04-6

/ Natural rubber.

24270

/ 000069-72-7

/ Salicylic acid.

24280

/ 000111-20-6

/ Sebaceous acid.

24430

/ 002561-88-8

/ Sebaceous anhydride.

24475

/ 001313-82-2

/ Sodium sulfide.

24490

/ 000050-70-4

/ Sorbitol.

24520

/ 008001-22-7

/ Soybean oil.

24540

/ 009005-25-8

/ Starch, food quality.

24550

000057-11-4

/ Stearic acid.

24610

/ 000100-42-5

/ Styrene.

24820

/ 000110-15-6

/ Sucinic acid.

24850

/ 000108-30-5

/ Sucinic anhydrate.

24880

/ 000057-50-1

/ Sacarous.

24887

/ 006362-79-4

/ Acid monosodic salt 5-sulfoisoftálico.

/ LME = 0.05 mg/Kg.

24888

/ 003965-55-7

/ Monosodic salt of the 5-sulfoisoftalato of dimethyl.

/ LME = 0.05 mg/Kg.

24910

/ 000100-21-0

/ Terephalic acid.

/ LME = 7.5 mg/Kg.

24940

/ 000100-20-9

/ Tereftalic acid dichloride.

/ LME(T) = 7.5 mg/Kg (expressed as tereftalic acid).

24970

/ 000120-61-6

/ T-methyl tephthalate.

25090

/ 000112-60-7

/ Tetraetilenglicol.

25120

/ 000116-14-3

/ Tetrafluoroethylene.

/ LME = 0.05 mg/Kg.

25150

/ 000109-99-9

/ Tetrahydrofurano.

/ LME = 0.6 mg/Kg.

25180

/ 000102-60-3

/ N,N,N-,N-Tetrakis (2-hydroxypropil) ethylenediamine.

25210

/ 000584-84-9

/ 2.4-Toluilene Disociate.

/ QM(T) = 1 mg/Kg in PT (expressed as NCO).

25240

/ 000091-08-7

/ 2,6-Diissociation of toluilene.

/ QM(T) = 1 mg/Kg in PT (expressed as NCO).

25270

/ 026747-90-0

/ 2.4-Diissocyanate of dimerized toluilene.

/ QM(T) = 1 mg/Kg in PT (expressed as NCO).

25360

/

/ Trialquil (C-C) acetate of 2,3-epoxipropilo.

/ LME = 6 mg/Kg.

25420

/ 000108-78-1

/ 2,4,6-Triamino-

1,3,5-Triazina.

/ LME = 30 mg/Kg.

25510

/ 000112-27-6

/ Trietilenglicol.

25600

/ 000077-99-6

/ 1.1.1-Trimetilolpropane.

/ LME = 6 mg/Kg.

25910

/ 024800-44-0

/ Tripropilenglicol.

25960

000057-13-6

/ Urea.

26050

/ 000075-01-4

/ Vinyl chloride.

/ See Council Directive 78/142/EEC.

26110

/ 000075-35-4

/ Vinyliden chloride.

/ QM = 5 mg/Kg in PT or LME = not detectable (LD = 0.05 mg/Kg).

SECTION B

The list of monomers and other starting substances that may continue to be used until their inclusion in section A is decided

N.o pm/ref (1) / N.o CAS (2) / Name (3) / Restrictions (4)

000542-02-9

/ Acetoguanamina.

/ See "2,4-diamino-6-methyl-1,3,5,triazine".

10160

/ 002206-94-2

/ Alpha-acetoxystyrene.

10162

/ 010521-96-7

/ Beta-acetoxiestireno.

10480

/

/ Saturated monocarboxylic alphatic acids (C2-C24).

10510

/

/ Unsaturated monocarboxylic alphatic acids (C3-C24).

10599/

70

/

/ Unsaturated fatty acids (C18).

10599/

90A

/ 061788-89-4

/ Distilated dimers of unsaturated fatty acids (C18).

10599/

91

/ 061788-89-4

/ Non-distilated dimers of unsaturated fatty acids (C18).

10599/

92A

/ 068783-41-5

/ Detylated hydrogenic dimers of unsaturated fatty acids (C18).

10599/

93

/ 068783-41-5

/ Non-distilated hydrogenic dimers of unsaturated fatty acids (C18).

10660

/ 015214-89-8

/ Acido acrilamidometilpropanosulfónico.

10930

/ 003066-71-5

/ Cyclohexyl acrylate.

11000

/ 050976-02-8

/ Deciclopentadienyl acrylate.

11050

/ 001070-70-8

/ Diacrilate 1.4-butanodiol.

11180

/ 017831-71-9

/ Tetraethylene glycol diacrilate.

11195

/ 068901-05-3

/ Diacrilate of tripropilenglicol.

11245

/ 002156-97-0

/ Dodecyl acrylate.

11500

/ 000103-11-7

/ 2-ethylhexyl acrylate.

11520

/ 002918-23-2

/ 2-hydroxyisopropyl acrylate (= 2-hydroxy-1-methyl acrylate).

11530

/ 000999-61-1

/ 2-hydroxypropyl acrylate.

11560

/ 005888-33-5

/ Isobornyl acrylate.

11620

/ 001330-61-6

/ Isodecyl acrylate.

11650

/ 029590-42-9

/ Isooctilo acrylate.

11695

/ 003121-61-7

/ 2-methoxyethyl acrylate.

11740

010095-13-3

/ 1,3-butanodiol monoacrylate.

11770

/ 002478-10-6

/ 1,4-butanodiol monoacrylate.

11800

/ 013533-05-6

/ Dietylene glycol monoacrylate.

12010

/ 040074-09-7

/ 2-sulfoetyl acrylate.

12040

/ 039121-78-3

/ Sulfopropyl acrylate.

12055

/ 094160-26-6

/ Triacrylate of glycerol's (2-hydroxypropylic).

12062

/ 075577-70-7

/ Triacrylate of Ether Tris (2-hydroxyethyl) of 1,1,1-trimethylolpropane.

12160

/ 002998-04-1

/ Dialog Adipate.

12190

/ 000105-97-5

/ Didecyl Adipate.

12220

/ 027178-16-1

/ Diisodecyl adipate.

12250

/ 000123-79-5

/ Dictyl adipate.

12265

/ 004074-90-2

/ Divinyl adipate.

12370

/

/ Alphatic monoalcohols saturated, linear, secondary or tertiary (C4-C22).

12610

/ 000107-18-6

/ Alilic alcohol.

12700

/ 000150-13-0

/ P-aminobenzoic acid.

12790

/ 000080-46-6

/ p-ter-Amilfenol.

12850

/ 029602-44-6

/ Azelato de bis (2-hydroxyethyl).

12910

/ 001732-10-1

/ Azelato de dimetilo.

000528-44-9

/ Acid 1.2.4-bencenotricarboxylic.

/ See “Trimeltic acid”.

13060

/ 004422-95-1

/ Acid trichloride 1.3,5-bencenotricarboxylic.

000091-76-9

/ Benzoguanamina.

/ See “2,4-Diamina-6-phenil-1,3,5-triazina”.

13328

/ 000104-38-1

/ Eter-bis (2-hydroxyethyl) of hydroquinone.

000080-09-1

/ Bisfenol S.

/ See “4,4 dihydroxydiphenylsulfona”.

13660

/ 000584-03-2

/ 1,2-Butanodiol. 13720

/ 000110-63-4

/ 1.4-Butanodiol.

13750

/ 000513-85-9

/ 2,3-Butanodiol.

13780

/ 002425-79-8

/ Eter bis (2.3-epoxypropylic) of 1.4-butanodiol.

/ QM(T) = 5 mg/Kg in PT (expressed as epoxy).

13810

/ 000505-65-7

/ 1.4-Butanodiolformal.

13932

/ 000598-32-3

/ 3-Buten-2-ol.

13960

/ 001852-16-0

/ N-(Butoximetil) acrylamide.

14020

/ 000098-54-4

/ 4-ter-Butilfenol.

14260

/ 000502-44-3

/ Caprolactama.

14800

/ 003724-65-0

/ Chronic acid.

15020

/ 002182-05-0

/ Cyclohexilvinyl ether.

15070

/ 001647-16-1

1.9-Decadiene.

15130

/ 000872-05-9

/ 1-Deceno.

15280

/ 000542-02-9

/ 2.4-Diamino-6-methyl-1,3,5-triazine.

15310

/ 000091-76-9

/ 2.4-Diamino-6-phenyl-1,3,5-triazine.

15340

/ 000109-76-2

/ 1.3-Diaminopropane.

15370

/ 003236-53-1

/ 1.6-Diamino-2,2,4-trimetilhexano.

15400

/ 003236-54-2

/ 1.6-Diamino-2,4,4-trimetilhexane.

15490

/ 002215-89-6

/ Eter 4,4--dicarboxidiphenyl.

15580

/ 001653-19-6

/ 2,3-Dichloro-1,3-butadiene.

15610 / 000080-07-9

4.4--Diclorodiferilsulfona.

15730

/ 000077-73-6

/ Dicicloropentadieno.

16090

/ 000080-09-1

4.4--Dihydroxyphenylsulfona.

16210

/ 006864-37-5

3,3--Dimethyl-4,4--diaminodicylexylmethane.

16270

/ 000526-75-0

/ 2,3-Dimetilphenol.

16300

/ 000105-67-9

/ 2.4-Dimetilphenol.

16330

/ 000095-87-4

/ 2.5-Dimetilphenol.

16360

/ 000576-26-1

2.6-Dimethylphenol.

16390

/ 000126-30-7

/ 2,2-Dimetil-1,3-propanodiol.

16450

/ 000646-06-0

/ 1.3-Dioxolano.

16540

/ 000102-09-0

/ Diphenyl carbonate.

16690

/ 001321-74-0

/ Divinilbenceno.

16697

/ 000693-23-2

/Dodecanedioic acid.

17040

/ 000149-57-5

/ Acid 2-ethylexanoic.

17050

/ 000104-76-7

/ 2-Etil-1-hexanol.

17110

/ 016219-75-3

/ 5-Etilidenbicycle

(2.2.1) hept-2-eno.

17350

/ 000105-75-9

/ Dibutyl Smoking.

18220

/ 068564-88-5

/ Acido N-heptilaminoundecanoic.

18370

/ 000592-45-0

/ 1.4-Hexadiene.

18400

/ 000592-42-7

/ 1.5-Hexadiene.

18441

/ 000085-42-7

/ Hexahydrophtalic anhydride.

18700

/ 000629-11-8

/ 1.6-Hexanodiol.

18820

/ 000592-41-6

/ 1-Hexeno.

18905

/ 002628-17-3

/ 4-Hydroxystyrene.

18970

/ 000078-83-1

/ Isobutanol.

19030

/ 016669-59-3

/ N-(Isobutoximetil) acrylamide.

19060

/ 000109-53-5

/ Isobutylvinyl ether.

19090

/ 000078-84-2

/ Isobutiraldehído.

19120

/ 025339-17-7

Isodecanol.

19130

/ 026896-18-4

/ Isonanoic acid.

19150

/ 000121-91-5

/ Isoft acid.

19180

/ 000099-63-8

/ isoftalic acid dichloride.

000078-79-5

Isopreno.

/ See «2-Methyl-1,3-butadiene».

19270

/ 000097-65-4

/ Itaconic acid.

19490

/ 000947-04-6

/ Laurolactama.

19570

/ 000999-21-3

/ Dialog case.

19600

/ 000105-76-0

/ Dibutyl case.

19936

/ 007423-42-9

/ Monkey case(2-ethylhexile).

19990

/ 000079-39-0

/ Metacrilamide.

20050

/ 000096-05-9

/ Alyl metacrilate.

20260

/ 000101-43-9

/ Cyclohexyl metacrilate.

20380

/ 001189-08-8

/ Dimetacrilate of 1.3-butanodiol.

20410

/ 002082-81-7

/ Diacrilate 1.4-butanodiol.

20440

/ 000097-90-5

/ Ethylene glycol dimetacrilate.

20470

/ 025852-47-5

/ Polyethylene glycol dimetacrilate.

20530

/ 002867-47-2

/ Metacrilate of 2-(dimetilamino) ethyl.

20590

/ 000106-91-2

/ Target 2,3-epoxypropyle.

/ QM(T) = 5 mg/Kg in PT (expressed as epoxy).

20740

/ 039670-09-2

/ Metacrilate of etoxitrietilenglicol.

20950

/ 000923-26-2

/ 2-hydroxypropyl metacrilate.

21115

/ 000816-74-0

/Metalyl metacrilate.

21220

/ 032360-05-7

/ Octadecyl metacrilate.

21370

/ 010595-80-9

/ 2-sulfoetyl metacrilate.

21400

/ 054276-35-6

/ Sulfopropyl metacrilate.

21520

/ 001561-92-8

/ Sodium Metalilsulfonate.

/ QM = 5 mg/Kg in PT.

21640

/ 000078-79-5

/ 2-Methyl-1,3-butadiene.

21730

/ 000563-45-1

/ 3-Methyl-1-butene.

21760

/ 000694-91-7

/ 5-Methylenebicycle

(2.2.1) hept-2-eno.

000505-65-7

/ 1.4-(Methylenedioxi) butane.

/ See “1,4-butanodiolformal”.

21837

/ 001116-90-1

/ 4-Methyl-1,4-hexadiene.

/ LME = ND (LD = 0.05 mg/Kg).

21970

/ 000923-02-4

/ n-Methylolmetacrilamide.

22210

/ 000098-83-9

/ alpha-Methylene.

22240

/ 000622-97-9

/ p-Methylene.

22270

/ 000107-25-5

/ Methylvinyl ether.

22360

/ 001141-38-4

/ Acid 2,6-naftalendicarboxylic.

000126-30-7

/ Neopentilglicol.

/ See «2,2-Dimetil-1,3-propanodiol».

22428

/ 051000-52-3

/ Neodeanate of vinyl.

22540

/ 000104-40-5

/ 4-Noniphenol.

000498-66-8

Norborneno.

/ See “Bicicle

(2.2.1) hept-

2-no."

22585

/ 003710-30-3

/ 1.7-Octadiene.

22720

/ 000140-66-9

/ 4-ter-Octilphenol.

22900

/ 000109-67-1

/ 1-Penteno.

22932

/ 001187-93-5

/ Eter perfluoromethylperfluorovinyl.

22937

/ 001623-05-8

/ Eter perfluoropropypilperfluorovinyl.

Fotallic acids.

/ See “Acido iso-u o-ftálico”.

23530

/ 025190-06-1

/ Poli (1.4-butilenglicol) (molecular weight above 1,000).

23770

/ 000504-63-2

/ 1.3-Propanodiol.

23920

/ 000105-38-4

/ Vinyl propianato.

24370

/ 000106-79-6

/ Dimethyl discharge.

24560

/ 000111-63-7

/ Vinyl stearate.

24760

/ 025914-43-2

/ Styrenosulphonic acid.

25030

/ 016646-44-9

/ Tetra (aliloxi) etano.

25161

/ 000085-43-8

/ Tetrahydrophtalic anhydride.

25300

000088-19-7

o-Toluensulfonamida.

25380

/ Trialquil (C-C) vinyl acetate (= vinyl acetate).

25390

/ 000101-37-1

/ Cianurato de trialilo.

25450

/ 026896-48-0

/ Triciclodecanodimetanol.

25480

/ 000102-71-6

/ Trietanolamine.

25540

/ 000528-44-9

/ Trimeltic acid.

/ QM (T) = 5 mg/Kg in PT.

25550

/ 000552-30-7

/ Trimeltic anhydrate.

/ QM (T) = 5 mg/Kg in PT (expressed as trimeltic acid).

25810

/ 015625-89-5

/ Triacrylate of 1.1.1-trimethylolpropane.

25840

/ 003290-92-4

/ Trimetacrylate of 1.1.1-trimethylolpropane.

25900

/ 000110-88-3

/ Trioxan.

000102-71-6

/ Tris(2-hydroxyethyl)amine.

/ See “Trietanolamine”.

26140

/ 000075-38-7

/ Vinyliden flower.

/ LME = ND. (LD = 0.05 mg/Kg).

26170

/ 003195-78-6

/ N-Vinil-N-methylacetamide.

/ QM = 5 mg/Kg in PT.

26230

/ 000088-12-0

/ Vinilpirrolidona.

26290

/ 025013-15-4

/ Viniltolueno.

000622-97-9

/ p-Viniltolueno.

/ See “p-Methylene”.

26320

/ 002768-02-7

/ Trimetoxivinylsilano.

/ QM = 5 mg/Kg in PT.

000105-67-9

/ m-Xilenol.

/ See "2,4-Dimetilphenol".

000526-75-0

/ o-Xilenol.

/ See “2,3-Dimetilphenol”.

000095-87-4

/ p-Xilenol.

/ See "2,5-Dimetilphenol".

Annex III

Health criteria to be applied for the inclusion of new products in positive lists

1. It will be determined whether a substance or matter can be inscribed on a positive list taking into account both the amount of substance or matter that can be transmitted

food product such as substance or matter toxicity.

2. A substance or matter shall be included in a positive list only when, under normal or foreseeable conditions of use of any material or object to which such substance or matter is involved, it cannot be transmitted to food products in an amount that may pose a danger to human health.

3. All substances or materials shall be subject to continuous monitoring and further examination when new scientific information or a further assessment of existing scientific data so warrant.

4. When an acceptable daily dose or tolerable daily dose is established for a substance or matter in particular, it will be appropriate to determine a specific migration limit in order to avoid overcoming such a dose. Where such specific migration limits are determined for a substance or matter, the remaining sources of possible exposures of the substance or matter should be taken into account.

5. The establishment of a specific migration limit for a substance or matter may not be the most valid means of protecting human health. In such cases, the need to protect human health will prevail over any other consideration when the appropriate actions to be envisaged are determined.

Annex IV

Basic standards for migration verification in food simulators

The determination of migration in food simulators will be carried out using the food simulators provided for in the present annex and under the conditions of testing set out therein. However, the determination of migration will be confined to the food simulator(s) and to the test condition(s) that, in the specific case examined, can be considered the strictest according to the experience.

Food simulators

1. The following non-exhaustive list of foodstuffs sets out the simulators to be used in the migration tests for a food product or a group of food products and will be indicated with the following abbreviations:

1.o Simulant A: distilled water or equivalent quality water.

2.o Simulant B: acetic acid at 3 % (P/V), in aqueous solution.

3.o Simulant C: ethanol at 15% (V/V), in aqueous solution.

4.o Simulant D: Corrected Olive Oil (1); when for technical reasons linked to the analysis method it was necessary to use other simulators, olive oil should be replaced by a mixture of synthetic triglycerides (2) or by sunflower oil (3). If all the simulants mentioned above are inappropriate, other simulators may be used as well as other weather and temperature conditions.

However, simulator A should be used only in the above-mentioned cases, specifically in the test conditions table.

2. For each food product or for each group of food products only the or the simulants indicated with the X sign will be used, using for each simulator a new sample of material or object in question. The absence of sign X means that no evidence will be required for such departure or subheading.

3. When the X sign appears followed by a figure that is separated by an oblique line, the result of the migration tests should be divided by that figure. This, called the "reducing coefficient", will take into account, in a conventional way, the greatest extraction power of the fatty food simulator in relation to certain types of food products.

4. If the X sign was accompanied, in brackets, from the letter to, only one of the two simulators indicated should be used:

1.o If the pH of the food product was higher than 4.5, the A simulator will be used.

2. If the pH of the food product was less or equal to 4.5, the B simulator will be used.

5. If a food product is listed under both a specific heading and a general heading, only the intended (s) simulator(s) should be used under the specific heading.

6. When the food product or group of food products are not included in the list of foodstuffs that are included below, the tests will be performed using, among the food simulators indicated in paragraph 1, those that most resemble the actual behavior of the food.

Notes

(1) Features of olive oil rectified:

Iodine index (Wijs)

= 80-88

Refrection index at 25 °C

= 1,4665-1,4679

Acidity (expressed in percentage of oleic acid)

= 0.5 % maximum

Index of peroxides (expressed in oxygen miliequivalents by Kg of oil).

= 10 maximum

(2) Composition of the mixture of synthetic triglycerides:

Distribution of fatty acids

Number of C atoms in fatty acid residues: 6 8 10 12 14 16 18 Other

GLC Zones (%) 1 6-9 8-11 45-52 12-15 8-10 8-12 OPS or = 1

Purity:

Content in monoglycerides (determined by enzyme)

roga or = 0.2 %

Diglyceride content (determined by enzyme)

▪ %

Non-sponsible materials

roga or = 0.2 %

Iodine index (Wijs)

1 %

Acidity index

1 %

Water content (K. Fischer)

1 %

Fusion point

28 +-2 °C.

Typical absorption spectrum (layer thickness: d = 1 cm; reference: water = 35 °C)

Wave length (nm) 290 310 330 350 370 390 430 470 510

Transmission (%)

2 15 37 64 80 88 95 97 98

At least 10 % of light transmission to 310 nm ( 1 cm top, reference: water to 35 °C.

(3) Sunflower oil characteristics:

Iodine index (Wijs)

120-145

Refrection index at 20 oC

= 1,474-1,476

Saponification index

= 188-193

Density relative to 20 °C

= 0.918-0.926

Non-sponsible materials

= 0.5 %-1.5 %.

Reference number / Denomination of food products / Simulants to be used: A

/ B

/ C

/ D

01

/ Drinks.

01.01

/ Non-alcoholic beverages or alcoholic beverages whose alcoholic grade is less than 5% vol:

/ Waters, ciders, fruit juices or vegetables, simple or concentrated, musts, fruit nectars, lemonades, sodas, jarabes, bitter, teas, coffee, tea, liquid chocolate, beers and others.

/ X(a)

/ X(a)

01.02

/ Alcoholic beverages whose alcoholic grade is 5 % vol or more:

Beverages classified under heading 01.01, but whose alcoholic grade is 5 % vol or more: wines, spirits.

/ X(*)

/ X(**)

01.03

/ Diverse: Ethyl alcohol without denaturalizing.

/ X(*)

/ X(**)

02

/ Cereals, derivatives of cereals, Galician products, bakery and pastry.

02.01

/ Starches and stools.

02.02

/ Cereals in natural state, in flakes, in foils (including swollen corn and corn petals and others).

02.03

/ Cereal harbors and semoles.

02.04

Food pastries.

02.05

/ Dry products of bakery, gallery and dry pastry products:

A) To present fat materials on their surface.

/ X/5

(B) Others.

02.06

/ Fresh bakery and pastry products:

A) To present fat materials on their surface.

/ X/5

(B) Others.

/ X

03

/ Chocolates, sugars and their derivatives, confectionery products.

03.01

/ Chocolates, chocolate-coated products, substitutes and products covered with substitutes.

/ X/5

03.02

/ Confectionery products:

A) Solidly:

I. Let them present fat materials on their surface.

/ X/5

II. Others.

B) In the form of pasta:

/ X/3

I. Let them present fat materials on their surface.

II. Humes.

/ X

03.03

/ Sugars and articles of confectionery:

A) Solidly.

B) Honey and similar.

/ X

C) Melazas or sugar syrups.

/ X

04

/ Fruits, vegetables and their derivatives.

04.01

/ Full, fresh or chilled fruits.

04.02

/ Transformed fruits:

A) Dry or dehydrated fruits, whole or in the form of flour or dust.

B) Fruits in pieces or in the form of puré or pasta.

/ X(a)

/ X(a)

C) Canned fruits (memelettes and similar products, whole fruits or in pieces, in the form of flour or powder, preserved in a liquid medium):

I. In a watery environment.

/ X(a)

/ X(a)

II. In a smelly medium.

/ X(a)

/ X(a)

/ X

III. In an alcoholic medium (“5 % vol).

/ X(*)

/ X

04.03

/ Fruits of peel (peanuts, chestnuts, almonds, hazelnuts, common nuts, pine nuts and others):

A) Decorticated, dried.

B) Decorticated and toasted.

/ X/5(***)

C) In the form of pasta or cream.

/ X

/ X/3(***)

04.04

/ Full vegetables, fresh or cooled.

04.05

/ Transformed vegetables:

A) Dry or dehydrated vegetables, whole, in the form of flour or dust.

B) Vegetables in pieces, in the form of puree.

/ X(a)

/ X(a)

C) Conserved vegetables:

I. In a watery environment.

/ X(a)

/ X(a)

II. In a smelly medium.

/ X(a)

/ X(a)

/ X

III. In an alcoholic medium (“5 % vol).

/ X(*)

/ X

05

/ Fats and oils.

05.01

/ Animal and vegetable oils, natural or processed (including cocoa butter, butter, melted butter).

/ X

05.02

/ Margarine, butter and other fats composed of oil emulsions of water.

/ X/2

06

/ Animal and eggs products.

06.01

/ Fish:

A) Fresco, refrigerated, salty, smoked.

/ X

/ X/3(***)

B) In the form of pasta.

/ X

/ X/3(***)

06.02

/ Crustaceans and mollusks (including oysters, mussels and snails) that are not naturally protected by their shell or shell.

/ X

06.03

/ Meats of all zoological species (including poultry and hunting):

/ X/4

A) Fresh, chilled, salty, smoked.

/ X

B) In the form of pasta, cream.

/ X

06.04

/ Products transformed from meat (jamon, sausage, bacon and others).

/ X

/ X/4

06.05

/ Conserves or semiconserves of meat or fish:

A) In a watery environment.

/ X(a)

/ X(a)

B) In a smelly medium.

/ X(a)

/ X(a)

/ X

06.06

/ Eggs without shell:

A) Powder or dry.

(B) Others.

/ X

06.07

/ Egg yolk:

A) Liquid.

/ X

B) Powdered or frozen.

06.08

/ Dry egg white.

07

/ Dairy products.

07.01

/ Milk:

A) Enter.

/ X

B) Partially dehydrated.

/ X

C) Partial or totally unborn.

/ X

D) Totally dehydrated.

07.02

/ fermented milk, such as yogurt, whipped milk and its associations with fruit or fruit derivatives.

/ X

07.03

Nata and born acid.

/ X(a)

/ X(a)

07.04

/ Cheese:

A) Enteres, with bark.

B) Founded.

/ X(a)

/ X(a)

C) All the others.

/ X(a)

/ X(a)

/ X/3(***)

07.05

/ Cuajo:

A) Liquid or pasty.

/ X(a)

/ X(a)

B) Powder or drying.

08

/ Miscellaneous products.

08.01

/ Vinegar.

/ X

08.02

/ Fried or roasted foods:

A) Potato fries, fries and others. / X/5

B) Of animal origin.

/ X/4

08.03

Preparation of soups, potages or prepared broths (extracts, concentrates), homogeneized heterogeneous food preparations, prepared dishes:

A) In powder or drying:

I. Let them present fat materials on their surface.

/ X/5

II. Others.

B) Liquids or pastures:

I. Let them present fat materials on their surface.

/ X(a)

/ X(a)

/ X/3

II. Others.

/ X(a)

/ X(a)

08.04

/ Ferminant yeasts or substances:

A) In pasta.

/ X(a)

/ X(a)

(b) Drying.

08.05

/ Kitchen salt.

08.06

/ Salsas:

A) That they do not present fat materials on their surface.

/ X(a)

/ X(a)

B) mayonnaise, sauces derived from mayonnaise, salad cream and other emulsified sauces (emulsion of type of oil in water).

/ X(a)

/ X(a)

/ X/3

C) Salsa containing oil and water that form two different layers.

/ X(a)

/ X(a)

/ X

08.07

/ Mustards (with the exception of mustards powdered from heading 08.17).

/ X(a)

/ X(a)

/ X/3(***)

08.08

/ slices of bread, sandwiches, toast and others containing any kind of food:

A) To present fat materials on their surface.

/ X/5

(B) Others.

08.09

/ Ice cream.

/ X

08.10

/ Dry foods:

/ A) To present fat materials on your surface.

(B) Others.

/ X/5

08.11

/ Frozen or superfreeze foods.

08.12

/ Concentrated extracts whose alcoholic grade is 5 % alcohol vol or more.

/ X(*)

/ X

08.13

/ Cocoa:

A) Dust cocoa.

/ X/5(***)

B) Cocoa in pasta.

/ X/3(***)

08.14

/ Coffee, even toasted or decaffeinated or soluble, granular or powdered coffee substitutes.

08.15

/ Liquid coffee extracts.

/ X

08.16

/ aromatic plants and other plants: chamomile, malva, mint, tea, tila and others.

08.17

/ Species and aromas in their normal state: cinnamon, nail, mustard powder, pepper, vanilla, saffron and others.

(*) This test will be performed only if the pH is less or equal to 4.5.

(**) This test may be done in the case of liquids or beverages whose degree of alcohol is more than 15% of vol of alcohol with ethanol in aqueous solution of a similar concentration.

(***) If with an appropriate test it is possible to demonstrate that no "greasy contact" will be established with the plastic material, the test may be omitted with the D simulator.

Rehearsal conditions (times and temperatures)

1. The migration tests will be performed by choosing, between the times and the temperatures indicated in the table, the conditions that are closest, without being less than the usual or foreseeable contact conditions of the plastic materials and objects under study.

2. If a material or object exceeds a test of a duration determined at a given temperature, it will not be necessary to submit it to another test of lower duration and same temperature, or to another one of the same duration and lower temperature.

3. However, in the case of a plastic material or object intended to be used in several of the time and temperature conditions in the table, migration will be determined by subjecting such material or object to all the corresponding conditions of testing and using the same portion of the food simulator.

4. If a material or object of plastic matter is intended to contact food products in any condition of time, the following test conditions shall be used:

(a) When, in actual use, a material or object of plastic matter is used at a temperature not exceeding 70 °C, and this is indicated in the label or in the instructions, only the test(s) must be performed from 10 days to 40 °C.

(b) When in actual use a material or object is used at a temperature above 70 °C:

1.o If there is no labeling or instructions indicating the temperature provided for in the actual use, the B and C simulants will be used at the reflux temperature, if possible, and if not two hours at 100 °C and the D simulator will be used two hours at 175 °C.

2. If there is a label or instructions indicating the conditions provided for in the actual use, the corresponding times and temperatures of the picture will be selected.

5. Notwithstanding the conditions provided for in the table and in paragraph 2 if a material or object of plastic matter is used for periods less than fifteen minutes at temperatures between 70 °C and 100 °C and this is indicated in the label or instructions, only two hours to 70 °C and 10 days to 40 °C should be performed. For each of these two types of tests, you need to use a new sample of the same material or object to study.

6. If it is verified that the development of the tests under the conditions provided for in the table causes physical or other material and objects, which do not occur in the normal or foreseeable conditions of use of the material or object, the migration tests shall be carried out in the most appropriate conditions to the specific case.

7. In the migration tests of plastic materials and objects for use in microwave ovens, a conventional oven will be used in the selected relevant time and temperature conditions of the picture.

(DOOR OPENING)