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Order Sco/983/2003, Of April 15, That Amending The Annexes Of The Royal Decree 118/2003, 31 January, Which Approves The List Of Substances Permitted For The Manufacture Of Plastic Materials And Articles Intended To Come Into Co...

Original Language Title: ORDEN SCO/983/2003, de 15 de abril, por la que se modifican los anexos del Real Decreto 118/2003, de 31 de enero, por el que se aprueba la lista de sustancias permitidas para la fabricación de materiales y objetos plásticos destinados a entrar en co...

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TEXT

Royal Decree 118/2003, of 31 January, has merged into a single text the Royal Decrees 2207/1994, 1752/1998 and 442/2001, and incorporated into our legal order Directive 2001 /62/EC of the Commission of 9 August. Furthermore, the provisions of Directive 2002/72/EC are laid down in the said Royal Decree, as a codification of Directive 90 /128/EEC and its subsequent amendments, except those introduced by Directive 2002/17/EC of the European Parliament and of the Council Commission, of 21 February.

The existence of new scientific data and a review of existing data, based on the evaluations carried out by the Scientific Committee for Food (SCF), has led to an update of the lists. Community of authorised substances for plastic materials and articles by Directive 2002/17/EC of the Commission of 21 February 2002 amending Directive 90 /128/EEC.

This Order incorporates into our legal order the aforementioned Directive 2002/17/EC, in order to adapt the existing provisions to the new information available on plastic materials and objects destined to enter into In addition to Section A of Annex II to Royal Decree 118/2003 of 31 January, certain substances and the deletion of other substances from Section B of the said Annex, as well as the restrictions on some of the those substances.

Also, as a result of the transposition being carried out, substances are added to the list of additives in Sections A and B of Annex V to that Royal Decree and the content of the restrictions column and/or specifications laid down for certain additives.

In addition, in order to transpose Directive 2002/17/EC, specifications for Divinylbenzene are set out, as it is necessary to amend Annex VII to the aforementioned Royal Decree 118/2003 of 31 January.

This Order is dictated by the use of the powers conferred on the final disposition of Royal Decree 118/2003 of 31 January.

In its virtue, ears of the affected sectors and previous mandatory report of the Inter-Ministerial Commission for Food Management, I have:

Single item. Amendment of Annexes II, V and VII to Royal Decree 118/2003 of 31 January.

The purpose of this Order is to amend Annexes II, V and VII to Royal Decree 118/2003 in the terms set out in the Annex to this Order, as follows:

1. Annex II is amended as follows:

(a) In point 8.

i) The definitions of the concepts CM (T), LME and LME (T) are replaced.

ii) The definitions of the CMA and CMA (T) concepts are included

b) In Section A:

i) The following monomers and other starting substances are inserted: Boric acid; Diphenylsulfone; 6hydroxy-2-naphthalenecarboxylic acid; N-(4-hydroxyphenyl) acetamide; (40% w/w) 1,6-diisocyanate mixture of 2,2, 4-trimethylhexane and (60% w/w) 1,6-diisocyanate of 2,4, 4-trimethylhexane.

ii) The contents of the column Restrictions and/or specifications for monomers and other starting substances: 2, 2-Bis (4-hydroxyphenyl) propane bis (2,3-epoxypropyl) ether (=Badge) are amended; Bis (4-isocyanatocyclohexyl) methane; Chlorotrifluoroethylene; Cyclohexyl isocyanate; 4,4 ' -Diisocyanate of dicyclohexylmethane:

4,4 '-Diisocyanate of 3,3'-dimethyldiphenyl; 4,4 '-Diphenyl diphenyl ether; 2,4' -Diphenylmethane diisocyanate; 4,4 ' -Diphenylmethane diisocyanate; Hexamethylene diisocyanate; 1-isocyanate of 3-isocyanatomethyl-3,5, 5-trim-trim-trimethylene thylcyclohexane; 1,5-naphthylene diisocyanate; octadecyl isocyanate; 2,4-toluene diisocyanate; 2, 6-toluene diisocyanate; 2,4-dimerized toluene diisocyanate.

iii) Notes (23), (24), (25), and (26) are added.

iv) The following monomers and other starting substances are transferred from Section B to the Section:

Benzoguanamine; 1,4-Butanediol; 2, 4-Diamino-6-phenyl-1,3,5-triazine; Divinylbenzen; N-dodecanedioic acid; Trimethacrylate 1,1,1-trimethylolpropane.

2. Annex V is amended as follows:

a) In the table in Section A:

i) The following additives are inserted: Barium tetraborate; Boric acid; 1,4-Butanediol; Tetrakis (2-cyano-3,3-diphenylacrylate) of pentaerythritol; Sodium tetraborate.

ii) The content of the Restrictions and/or Specifications column is replaced for the following additives:

Benzaldehyde; bis-(polyethylene glycol) hydroxymethylphosphonate; Alcanfor.

iii) The additive 2, 4-Bis (octylthiomethyl)-6-methyl-phenol is deleted.

(b) The table in Section B is amended as follows:

following additives are inserted: Ester 2-ethylhexyl of 2-cyano-3,3-diphenylacrylic acid; N-octylphosphonic acid; Trimethyoloprano trimethacrylate-methyl methacrylate copolymer.

(ii) The contents of the column Restrictions and/or specifications are replaced for the additives: N, N-bis (2-hydroxyethyl) alkyl (C8-C18) amine; Diphenylsulfone.

(iii) The notes in Annex V to the Restrictions and/or Specifications column are amended as follows:

Notes (12) and (13) are replaced.

The following notes (23), (24), (25), and (26) are added.

3. Annex VII is amended as follows:

The specifications of the additive Divinylbenzene are inserted in the table in Part B.

Single end disposition. Entry into force.

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

Madrid, April 15, 2003.

PASTOR JULIAN

ANNEX

The Annexes to Royal Decree 118/2003 are amended as follows:

ANNEX II

a) The following definitions are replaced in point 8:

CM (T) = Maximum amount allowed 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 shall be determined by a validated analytical method; if no such method exists, an analytical method which has the necessary sensitivity may be used. to reliably determine the specified limit, pending the development of a validated method.

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 shall be determined by a validated analytical method. If there is no such method at present, an analytical method may be used which has the necessary sensitivity to reliably determine the specified limit, pending the development of a validated method.

LME (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 substances shall be determined by a validated analytical method. If there is no such method at present, an analytical method may be used which has the necessary sensitivity to reliably determine the specified limit, pending the preparation of a validated method.

i) After CM (T) the following definitions are inserted:

CMA = Maximum amount allowed of "residual" substance in the finished material or object, expressed in mg per 6 dm2 of the surface in contact with the food products; for the purposes of this Royal Decree, the quantity of the substance on the surface of the material or object shall 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 possesses the sensitivity necessary to determine the limit fiably. specified, pending the development of a validated method.

CMA (T) = Maximum allowed amount of "residual" substance in the material or object, expressed in mg of the total of the groups or substances indicated by 6 dm2 of the surface in contact with the food products; for the purposes of present Royal Decree, the quantity of the substance on the surface of the material or object shall be determined by a validated analytical method; if such method does not exist for the time being, an analytical method which possesses the necessary sensitivity may be used. to reliably determine the specified limit, pending the development of a validated method.

b) In Section A:

i) The following monomers and other starting substances are inserted:

(SEE IMAGES, PAGES 16040 TO 16042)

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

13620 10043-35-3 Boric acid. SML (T) = 6 mg/kg (23) (expressed as boron), without prejudice to the provisions of the Regulatory Regulation for water for human consumption.

16650 00127-63-9 Diphenylsulfone. SML (T) = 3 mg/kg (25).

18897 16712-64-4 6-hydroxy-2-naphthalene-carboxylic acid. SML = 0,05 mg/kg.

18898 103-90-2 N-(4-hydroxyphenyl) acetamide. For use only in liquid crystals and behind a barrier layer in multilayer plastics.

22332 28679-16-5 Mix of (40% w/w) 1,6-diisocyanate of 2,2,4-trimethylhexane and (60% w/w) 1, 6-diisocyanate of 2,4,4-trimethylhexane.

CM (T) = 1 mg/kg in PT (expressed as NCO) (26).

(ii) monomers and other starting substances for which the content of the column has been modified:

Restrictions and/or Specifications:

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

13510 001675-54-3 Ether bis (2,3-epoxypropyl) of 2, 2-bis-(4-hydroxyphenyl) propane (= BADGE).

According to the Royal Decree on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs.

13560 005124-30-1 Bis (4-isocyanatocyclohexyl) methane. See "4,4 ' -Diisocyanate of dicyclohexylmethane".

14650 000079-38-9 Chlorotrifluoroethylene. CMA= 0.5 mg/6 dm2.

14950 003173-53-3 Cyclohexyl isocyanate. CM (T) = 1 mg/kg in PT (expressed as NCO) (26).

15700 005124-30-1 4,4 ' -Decyclo-hexylmethane diisocyanate. CM (T) = 1 mg/kg in PT (expressed as NCO) (26).

16240 000091-97-4 4,4 '-Diisocyanate of 3,3' dimethyl diphenyl. CM (T) = 1 mg/kg in PT (expressed as NCO) (26).

16570 004128-73-8 4,4 ' -Diphenyl ether diisocyanate. CM (T) = 1 mg/kg in PT (expressed as NCO) (26).

16600 005873-54-1 2,4 ' -Diphenyl-methane diisocyanate. CM (T) = 1 mg/kg in PT (expressed as NCO) (26).

16630 000101-68-8 4,4 ' -Diphenyl-methane Diisocyanate. CM (T) = 1 mg/kg in PT (expressed as NCO) (26).

18640 000822-06-0 Hexamethylene Diisocyanate. CM (T) = 1 mg/kg in PT (expressed as NCO) (26).

19110 04098-71-9 1-Isocianato-3-isocyanatomethyl-3,5,5, -trimethylcyclohexane.

CM (T) = 1 mg/kg in PT (expressed as NCO) (26).

22420 003173-72-6 1,5-naphthylene diisocyanate. CM (T) = 1 mg/kg in PT (expressed as NCO (26).

22570 000112-96-9 Octadecyl Isocyanate. CM (T) = 1 mg/kg in PT (expressed as NCO) (26).

25210 000584-84-9 2,4-Toluene diisocyanate. CM (T) = 1 mg/kg in PT (expressed as NCO) (26).

25240 000091-08-7 2,6-Toluene diisocyanate. CM (T) = 1 mg/kg in PT (expressed as NCO) (26).

25270 026747-90-0 2,4-Dimerized toluene diisocyanate. CM (T) = 1 mg/kg in PT (expressed as NCO) (26).

iii) The following notes are added: (23), (24), (25) and (26).

(23) SML (T) means in this case that the sum of the migration of the following substances, marked with the n.os PM/REF.: 13620, 36840,40320 and 87040, must not exceed the indicated restriction.

(24) SML (T) means in this case that the sum of the migration of the following substances, marked with the n.os PM/REF.: 13720 and 40580, should not exceed the indicated restriction.

(25) SML (T) means in this case that the sum of the migration of the following substances, marked with the n.os PM/REF.: 16650 and 51570, must not exceed the indicated restriction.

(26) CM (T), in this case means that the sum of the residual quantities of the following substances, marked with the n.os PM/REF.: 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270, must not exceed the indicated restriction.

iv) monomers and other starting substances that are transferred from Section B to Section A.

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

13075 00091-76-9 Benzoguanamine. See '2,4-Diamino-6-phenyl-1,3,5-Triazine'.

13720 00110-63-4 1,4-Butanediol. SML (T) = 0,05 mg/kg (24).

15310 00091-76-9 2,4-Diamino-6-phenyl-1,3,5-triazine. CMA = 5 mg/6 dm2.

16690 01321-74-0 Divinylbenzene. CMA = 0,01 mg/6 dm2 or SML = ND (LD = 0,02 mg/kg, analytical tolerance included) for the sum of divinylbenzene and ethylvinylbenzene and according to the specifications set out in Annex VII.

16697 00693-23-2 N-dodecanedioic acid.

25840 03290-92-4 Trimethacrylate 1,1,1-trimethylolpropane. SML = 0,05 mg/kg.

2. Annex V is amended as follows:

a) In the table in Section A:

i) The following additives are inserted:

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

36840 12007-55-5 Barium tetraborate. SML (T) = 1 mg/kg expressed as barium (12) and SML (T) = 6 mg/kg (23) (expressed as boron), without prejudice to the regulatory standards for human consumption water.

40320 100043-35-3 Boric acid. SML (T) = 6 mg/kg (23) (expressed as boron), without prejudice to the provisions of the Regulatory Regulation for water for human consumption.

40580 00110-63-4 1,4-Butanediol. SML (T) = 0,05 mg/kg (24).

71670 178671-58-4 Tetrakis (2-cyano-3,3-diphenyl-acrylate) of pentaerythritol.

LME = 0.05 mg/kg.

87040 01330-43-4 Sodium tetraborate. SML (T) 6 mg/kg (23) (expressed as boron), without prejudice to the provisions of the Regulatory Regulation for water for human consumption.

(ii) Additives for which the content of the column has been modified: Restrictions and/or specifications:

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

37360 000100-52-7 Benzaldehyde. According to the note (9).

40120 68951-50-8 bis (polyethylene glycol) hydroxymethylphosphonate.

LME= 0.6 mg/kg.

41680 000076-22-2 Alcanfor. According to the note (9).

iii) The following additive is deleted:

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

40020 110553-27-0 2,4-Bis (octylthiomethyl)-6-methyl-phenol. LME= 6 mg/kg.

(b) The table in Section B is amended as follows:

i) The following additives are inserted:

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

45650 6197-30-4 Ester 2-ethylhexyl of 2-cyano-3, 3-diphenylacrylic acid.

LME = 0.05 mg/kg.

68860 04724-48-5 N-octylphosphonic Acid. SML = 0,05 mg/kg.

95000 28931-67-1 Trimethylolpropane trimethacrylate-methyl methacrylate copolymer.

(ii) Additives for which the content of the column has been modified: Restrictions and/or specifications:

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

39120 N, N-bis (2-hydroxyethyl) alkyl (C8-C18) amine.

SML (T) = 1,2 mg/kg (13) expressed as tertiary amine (excluding Cl H).

51570 00127-63-9 Diphenylsulfone. SML = 3 mg/kg (25).

iii) The notes in Annex V to the Restrictions and/or Specifications column are amended as follows:

a) Notes (12) and (13) are replaced by the following:

(12) SML (T) means in this case that the sum of the migration of the following substances, marked with the n.os PM/REF.: 36720, 36800, 36840 and 92000, must not exceed the indicated restriction.

(13) SML (T) means in this case that the sum of the migration of the following substances, marked with the n.os PM/REF.: 39090 and 39120, should not exceed the indicated restriction.

b) The following notes are added: (23), (24), (25), and (26):

(23) SML (T) means in this case that the sum of the migration of the following substances, marked with the n.os PM/REF.: 13620, 36840,40320 and 87040, must not exceed the indicated restriction.

(24) SML (T) means in this case that the sum of the migration of the following substances, marked with the n.os PM/REF.: 13720 and 40580, should not exceed the indicated restriction.

(25) SML (T) means in this case that the sum of the migration of the following substances, marked with the n.os PM/REF.: 16650 and 51570, must not exceed the indicated restriction.

(26) CM (T), in this case means that the sum of the residual quantities of the following substances, marked with the n.os PM/REF.: 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270, must not exceed the indicated restriction.

3. Annex VII is amended as follows:

The following specifications are inserted in the table in Part B:

N. or PM/REF. Other specifications.

16690. Divinylbenzene.

It may contain up to 40% of ethylvinylbenzene.