Commission Directive 2007/19/EC of 30 March 2007 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food and Council Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance )

• CELEX: Directive 2007/19/EC
• Articles: 13

Article 1

Directive 2002/72/EC is amended as follows:

1.

Article 1 is amended as follows:

(a)

paragraph 2 is replaced by the following:

‘2.   This Directive shall apply to the following materials and articles which, in the finished product state, are intended to come into contact or are brought into contact with foodstuffs and are intended for that purpose (hereafter referred to as “plastic materials and articles”):

(a)

materials and articles and parts thereof consisting exclusively of plastics;

(b)

plastic multi-layer materials and articles;

(c)

plastic layers or plastic coatings, forming gaskets in lids that together are composed of two or more layers of different types of materials.’

(b)

paragraph 4 is replaced by the following:

‘4.   Without prejudice to paragraph 2(c), this Directive shall not apply to materials and articles composed of two or more layers, one or more of which does not consist exclusively of plastics, even if the one intended to come into direct contact with foodstuffs does consist exclusively of plastics.’

2.

The following Article 1a is inserted:

‘Article 1a

For the purpose of this Directive the following definitions shall apply:

(a)

“plastic multi-layer material or article” means a plastic material or article composed of two or more layers of materials, each consisting exclusively of plastics, which are bound together by means of adhesives or by other means;

(b)

“plastic functional barrier” means a barrier consisting of one or more layers of plastics which ensures that the finished material or article complies with Article 3 of Regulation (EC) No 1935/2004 of the European Parliament and of the Council  ( *1 ) and with this Directive;

(c)

“non-fatty foods” means foods for which in migration testing simulants other than simulant D are laid down in Directive 85/572/EEC.

( *1 )

OJ L 338, 13.11.2004, p. 4 .’

"

3.

Article 2 is replaced by the following:

‘Article 2

1.   Plastic materials and articles shall not transfer their constituents to foodstuffs in quantities exceeding 60 milligrams of the constituents released per kilogram of foodstuff or food simulant (mg/kg) (overall migration limit).

However, this limit shall be 10 milligrams per square decimetre of surface area of material or article (mg/dm 2 ) in the case of the following:

(a)

articles which are containers or are comparable to containers or which can be filled, with a capacity of less than 500 millilitres (ml) or more than 10 litres (l);

(b)

sheet, film or other material or articles which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of such material or article and the quantity of food in contact therewith.

2.   For plastic materials and articles intended to be brought into contact with or already in contact with food intended for infants and young children, as defined by Commission Directives 91/321/EEC  ( *2 ) and 96/5/EC  ( *3 ) , the overall migration limit shall always be 60 mg/kg.

( *2 )

OJ L 175, 4.7.1991, p. 35 ."

( *3 )

OJ L 49, 28.2.1996, p. 17 .’

"

4.

In Article 4(2), the date of ‘1 July 2006’ is replaced by ‘1 April 2008’.

5.

The following Articles 4c, 4d and 4e are inserted:

‘Article 4c

For the use of additives for the manufacture of plastic layers or plastic coatings in lids referred to in Article 1(2)(c), the following rules shall apply:

(a)

for the additives listed in Annex III, the restrictions and/or specifications on their use set out in that Annex shall apply, without prejudice to Article 4(2);

(b)

by way of derogation from Article 4(1) and Article 4a(1) and (5), additives not listed in Annex III may continue to be used, until further review, subject to national law;

(c)

by way of derogation from Article 4b Member States may continue to authorise additives for the manufacture of plastic layers or plastic coatings in lids referred to in Article 1(2)(c) at national level.

Article 4d

For the use of additives exclusively acting as polymerisation production aids which are not intended to remain in the finished article (hereinafter PPAs), for the manufacture of plastic materials and articles, the following rules shall apply:

(a)

for the PPAs listed in Annex III, the restrictions and/or specifications on their use set out in Annex III shall apply, without prejudice to Article 4(2);

(b)

by way of derogation from Article 4(1) and Article 4a(1) and (5), the PPAs not listed in Annex III may continue to be used, until further review, subject to national law;

(c)

by way of derogation from Article 4b, Member States may continue to authorise PPAs at national level.

Article 4e

The use of azodicarbonamide, Ref. No 36640 (CAS No 000123-77-3) in the manufacture of plastic materials and articles is prohibited.’

6.

In Article 5a paragraph 2 is replaced by the following:

‘2.   At the marketing stages other than the retail stages, plastic materials and articles which are intended to be placed in contact with foodstuffs and which contain additives referred to in paragraph 1 shall be accompanied by a written declaration containing the information referred to in Article 9.’

7.

In Article 7 the following paragraph is added:

‘For plastic materials and articles intended to be brought into contact with or already in contact with food for infants and young children, as defined by Directives 91/321/EEC and 96/5/EC, the SMLs shall always be applied as mg/kg.’

8.

The following Article 7a is inserted:

‘Article 7a

1.   In a plastic multi-layer material or article, the composition of each plastic layer shall comply with this Directive.

2.   By way of derogation from paragraph 1, a layer which is not in direct contact with food and is separated from the food by a plastic functional barrier, may, provided that the finished material or article complies with the specific and overall migration limits specified in this Directive:

(a)

not comply with the restrictions and specifications set in this Directive,

(b)

be manufactured with substances other than those included in this Directive or in the national lists concerning the plastic materials and articles intended to come into contact with food.

3.   The migration of the substances referred to in paragraph 2(b) into food or simulant shall not exceed 0,01 mg/kg, measured with statistical certainty by a method of analysis in accordance with Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council  ( *4 ) . This limit shall always be expressed as concentration in foods or simulants. It shall apply to a group of compounds, if they are structurally and toxicologically related, in particular isomers or compounds with the same relevant functional group, and shall include possible set-off transfer.

4.   The substances referred to in paragraph 2(b) shall not belong to either of the following categories:

(a)

substances classified as proved or suspect “carcinogenic”, “mutagenic” or “toxic to reproduction” substances in Annex I to Council Directive 67/548/EEC  ( *5 ) ;

(b)

substances classified under the self-responsibility criteria as ‘carcinogenic’, ‘mutagenic’ or ‘toxic to reproduction’ according to the rules of Annex VI to Directive 67/548/EEC.

( *4 )

OJ L 165, 30.4.2004, p. 1 , as corrected by OJ L 191, 28.5.2004, p. 1 ."

( *5 )

OJ 196, 16.8.1967, p. 1 .’

"

9.

In Article 8 the following paragraph 5 is added:

‘5.   Notwithstanding paragraph 1, for phthalates (Ref. No 74640, 74880, 74560, 75100, 75105) referred to in Annex III Section B, the verification of the SML shall only be performed in food simulants. However, verification of the SML may be performed in food where the food has not already been in contact with the material or article and is pre-tested for the phthalate and the level is not statistically significant or greater than or equal to the limit of quantification.’

10.

Article 9 is replaced by the following:

‘Article 9

1.   At the marketing stages other than the retail stage, plastic materials and articles as well as the substances intended for the manufacturing of those materials and articles, shall be accompanied by a written declaration in accordance with Article 16 of Regulation (EC) No 1935/2004.

2.   The declaration referred to in paragraph 1 shall be issued by the business operator and shall contain the information laid down in Annex VIa.

3.   Appropriate documentation to demonstrate that the materials and articles as well as the substances intended for the manufacturing of those materials and articles comply with the requirements of this Directive shall be made available by the business operator to the national competent authorities on request. That documentation shall contain the conditions and results of testing, calculations, other analysis, and evidence on the safety or reasoning demonstrating compliance.’

11.

Annexes I, II and III are amended in accordance with Annexes I, II and III to this Directive.

12.

The text in Annex IV to this Directive is inserted as Annex IVa.

13.

Annexes V and VI are amended in accordance with Annexes V and VI to this Directive.

14.

The text in Annex VII to this Directive is inserted as Annex VIa.

Article 2

The Annex to Directive 85/572/EEC is amended in accordance with Annex VIII to this Directive.

Article 3

1.   Member States shall adopt and publish, by 1 April 2008 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

They shall apply those provisions in such a way as to:

(a)

permit the trade in and use of plastic materials and articles intended to come into contact with food and complying with Directive 2002/72/EC, as amended by this Directive, from 1 April 2008;

(b)

prohibit the manufacture and importation into the Community of lids containing a gasket which do not comply with restrictions and specifications for Ref. No 30340; 30401; 36640; 56800; 76815; 76866; 88640 and 93760 laid down in Directive 2002/72/EC as amended by this Directive from 1 June 2008;

(c)

prohibit the manufacture and importation into the Community of plastic materials and articles intended to come into contact with food which do not comply with restrictions and specifications for phthalates Ref. No 74560; 74640; 74880; 75100; 75105 laid down in Directive 2002/72/EC as amended by this Directive from 1 June 2008;

(d)

without prejudice to point (b) and (c), prohibit the manufacture and importation into the Community of plastic materials and articles intended to come into contact with food which do not comply with Directive 2002/72/EC as amended by this Directive from 1 April 2009.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 4

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union .

Article 5

This Directive is addressed to the Member States.

Schedules & Appendices

ANNEX I

ANNEX I

Annex I to Directive 2002/72/EC is amended as follows:

(1)

The following points 2a and 2b are inserted:

2a.   Correction of specific migration in foods containing more than 20 % fat by the Fat Reduction Factor (FRF):

“Fat Reduction Factor” (FRF) is a factor between 1 and 5 by which measured migration of lipophilic substances into a fatty food or simulant D and its substitutes shall be divided before comparison with the specific migration limits.

General rules

Substances considered “lipophilic” for the application of the FRF are listed in Annex IVa. The specific migration of lipophilic substances in mg/kg (M) shall be corrected by the FRF variable between 1 and 5 (M FRF ). The following equations shall be applied before comparison with the legal limit:

M FRF  = M/FRF

and

FRF = (g fat in food/kg of food)/200 = (% fat × 5)/100

This correction by the FRF is not applicable in the following cases:

(a)

when the material or article is or is intended to be brought in contact with food containing less than 20 % fat;

(b)

when the material or article is or is intended to be brought in contact with food intended for infants and young children as defined by Directives 91/321/EEC and 96/5/EC;

(c)

for substances in the Community lists in Annexes II and III having a restriction in column (4) SML= ND or non-listed substances used behind a plastic functional barrier with a migration limit of 0,01 mg/kg;

(d)

for materials and articles for which it is impracticable to estimate the relationship between the surface area and the quantity of food in contact therewith, for example due to their shape or use, and the migration is calculated using the conventional surface area/volume conversion factor of 6 dm 2 /kg.

This correction by the FRF is applicable under certain conditions in the following case:

For containers and other fillable articles with a capacity of less than 500 millilitres or more than 10 litres and for sheets and films in contact with foods containing more than 20 % fat, either the migration is calculated as concentration in the food or food simulant (mg/kg) and corrected by the FRF, or it is re-calculated as mg/dm 2 without applying the FRF. If one of the two values is below the SML, the material or article shall be considered in compliance.

The application of the FRF shall not lead to a specific migration exceeding the overall migration limit.

2b.   Correction of specific migration in food simulant D:

The specific migration of lipophilic substances into simulant D and its substitutes shall be corrected by the following factors:

(a)

the reduction factor referred to in point 3 of the Annex to Directive 85/572/EEC, hereinafter termed simulant D Reduction Factor (DRF).

The DRF may not be applicable when the specific migration into simulant D is higher than 80 % of the content of the substance in the finished material or article (for example thin films). Scientific or experimental evidence (for example testing with the most critical foods) is required to determine whether the DRF is applicable. It is also not applicable for substances in the Community lists having a restriction in column (4) SML = ND or non-listed substances used behind a plastic functional barrier with a migration limit of 0,01 mg/kg.

(b)

the FRF is applicable to migration into simulants, provided the fat content of the food to be packed is known and the requirements mentioned in point 2a are fulfilled.

(c)

the Total Reduction Factor (TRF) is the factor, with a maximum value of 5, by which a measured specific migration into simulant D or a substitute shall be divided before comparison with the legal limit. It is obtained by multiplying the DRF by the FRF, when both factors are applicable.’

(2)

The following point 5a is inserted:

5a.   Caps, lids, gaskets, stoppers and similar sealing articles:

(a)

If the intended use is known, such articles shall be tested by applying them to the containers for which they are intended under conditions of closure corresponding to the normal or foreseeable use. It is assumed that these articles are in contact with a quantity of food filling the container. The results shall be expressed in mg/kg or mg/dm 2 in accordance to the rules of Articles 2 and 7 taking into account the whole contact surface of sealing article and container.

(b)

If the intended use of these articles is unknown, such articles shall be tested in a separate test and the result be expressed in mg/article. The value obtained shall be added, if appropriate, to the quantity migrated from the container for which it is intended to be used.’

ANNEX II

ANNEX II

Annex II to Directive 2002/72/EC is amended as follows:

(1)

Section A is amended as follows:

(a)

the following monomers and other starting substances are inserted, in the appropriate numerical order:

Ref. No

CAS No

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

‘15267

000080-08-0

4,4′-Diaminodiphenyl sulphone

SML = 5 mg/kg

21970

000923-02-4

N-Methylolmethacrylamide

SML = 0,05 mg/kg

24886

046728-75-0

5-Sulphoisophthalic acid, monolithium salt

SML = 5 mg/kg and for lithium

SML(T) = 0,6 mg/kg ( 8 ) (expressed as lithium)’

(b)

for the following monomers and other starting substances, the content of the column 4 ‘Restrictions and/or specifications’ is replaced by the following:

Ref. No

CAS No

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

‘12786

000919-30-2

3-Aminopropyltriethoxysilane

Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler when used for the reactive surface treatment of inorganic fillers and SML = 0,05 mg/kg when used for the surface treatment of materials and articles.

16450

000646-06-0

1,3-Dioxolane

SML = 5 mg/kg

25900

000110-88-3

Trioxane

SML = 5 mg/kg’

(2)

In section B, the following monomers and other starting substances are deleted:

Ref. No

CAS No

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

‘21970

000923-02-4

N-Methylolmethacrylamide’

ANNEX III

ANNEX III

Annex III to Directive 2002/72/EC is amended as follows:

(1)

Section A is amended as follows:

(a)

the following additives are inserted in the appropriate numerical order:

Ref. No

CAS No

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

‘38885

002725-22-6

2,4-Bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine

SML = 0,05 mg/kg. For aqueous foods only.

42080

001333-86-4

Carbon black

In compliance with the specifications laid down in Annex V.

45705

166412-78-8

1,2-cyclohexanedicarboxylic acid, diisononyl ester

62020

007620-77-1

12-Hydroxystearic acid, lithium salt

SML(T) = 0,6 mg/kg ( 8 ) (expressed as lithium)

67180

—

Mixture of (50 % w/w) phthalic acid n-decyl n-octyl ester, (25 % w/w) phthalic acid di-n-decyl ester, (25 % w/w) phthalic acid di-n- octyl ester.

SML = 5 mg/kg ( 1 )

71960

003825-26-1

Perfluorooctanoic acid, ammonium salt

Only to be used in repeated use articles, sintered at high temperatures.

74560

000085-68-7

Phthalic acid, benzyl butyl ester

To be used only as:

(a)

plasticizer in repeated use materials and articles;

(b)

plasticizer in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 91/321/EEC and products according to Directive 96/5/EC;

(c)

technical support agent in concentrations up to 0,1 % in the final product.

SML = 30 mg/kg food simulant.

74640

000117-81-7

Phthalic acid, bis (2-ethylhexyl) ester

To be used only as:

(a)

plasticizer in repeated use materials and articles contacting non-fatty foods;

(b)

technical support agent in concentrations up to 0,1 % in the final product.

SML = 1,5 mg/kg food simulant.

74880

000084-74-2

Phthalic acid, dibutyl ester

To be used only as:

(a)

plasticizer in repeated use materials and articles contacting non-fatty foods;

(b)

technical support agent in polyolefines in concentrations up to 0,05 % in the final product.

SML = 0,3 mg/kg food simulant.

75100

068515-48-0

028553-12-0

Phthalic acid, diesters with primary, saturated C 8 -C 10 branched alcohols, more than 60 % C 9 .

To be used only as:

(a)

plasticizer in repeated use materials and articles;

(b)

plasticizer in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 91/321/EEC and products according to Directive 96/5/EC;

(c)

technical support agent in concentrations up to 0,1 % in the final product.

SML(T) = 9 mg/kg food simulant ( 42 ).

75105

068515-49-1

026761-40-0

Phthalic acid, diesters with primary, saturated C 9 -C 11 alcohols more than 90 % C 10

To be used only as:

(a)

plasticizer in repeated use materials and articles;

(b)

plasticizer in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 91/321/EEC and products according to Directive 96/5/EC;

(c)

technical support agent in concentrations up to 0,1 % in the final product.

SML(T) = 9 mg/kg food simulant ( 42 ).

79920

009003-11-6

106392-12-5

Poly(ethylene propylene) glycol

81500

9003-39-8

Polyvinylpyrrolidone

In compliance with the specifications laid down in Annex V.

93760

000077-90-7

Tri-n-butyl acetyl citrate

95020

6846-50-0

2,2,4-Trimethyl-1,3-pentanediol diisobutyrate

SML = 5 mg/kg food. To be used in single-use gloves only.

95420

745070-61-5

1,3,5-tris (2,2-dimethylpropanamido)benzene

SML = 0,05 mg/kg food.’

(b)

for the following additives, the entries in columns 3 ‘Name’ and 4 ‘Restrictions and/or specifications’ are replaced by the following:

Ref. No

CAS No

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

‘43480

064365-11-3

Charcoal, activated

In compliance with the specifications laid down in Annex V.

45200

001335-23-5

Copper iodide

SML(T) = 5 mg/kg ( 7 ) (expressed as copper) and SML = 1 mg/kg ( 11 ) (expressed as iodine)

76845

031831-53-5

Polyester of 1,4-butanediol with caprolactone

The restriction for Ref. No 14260 and Ref. No 13720 shall be respected.

In compliance with the specifications laid down in Annex V.

81760

—

Powders, flakes and fibres of brass, bronze, copper, stainless steel, tin and alloys of copper, tin and iron

SML(T) = 5 mg/kg ( 7 ) (expressed as copper);

SML = 48 mg/kg (expressed as iron)

88640

008013-07-8

Soybean oil, epoxidised

SML = 60 mg/kg. However in the case of PVC gaskets used to seal glass jars containing infant formulae and follow-on formulae as defined by Directive 91/321/EEC or containing processed cereal-based foods and baby foods for infants and young children as defined by Directive 96/5/EC, the SML is lowered to 30 mg/kg.

In compliance with the specifications laid down in Annex V.’

(c)

the following additive is deleted:

Ref. No

CAS No

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

‘35760

001309-64-4

Antimony trioxide

SML = 0,04 mg/kg ( 39 ) (expressed as antimony).’

(2)

Section B is amended as follows:

(a)

the following additives are inserted, in the appropriate numerical order:

Ref. No

CAS No

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

‘35760

001309-64-4

antimony trioxide

SML = 0,04 mg/kg ( 39 ) (expressed as antimony)

47500

153250-52-3

N,N′-Dicyclohexyl-2,6-naphthalene dicarboxamide

SML = 5 mg/kg.

72081/10

—

Petroleum hydrocarbon resins (hydrogenated)

SML = 5 mg/kg ( 1 ) and in compliance with the specifications laid down in Annex V

93970

—

Tricyclodecanedimethanol bis(hexahydrophthalate)

SML = 0,05 mg/kg.’

(b)

for the following additives, the entries in columns 3 ‘Name’ and 4 ‘Restrictions and/or specifications’ are replaced by the following:

Ref. No

CAS No

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

‘47600

084030-61-5

Di-n-dodecyltin bis(isooctyl mercaptoacetate)

SML(T) = 0,05 mg/kg food ( 41 ) (as sum of mono-n-dodecyltin tris(isooctyl mercaptoacetate), di-n- dodecyltin bis(isooctyl mercaptoacetate), mono-dodecyltin trichloride and di-dodecyltin dichloride) expressed as the sum of mono- and di-dodecyltin chloride

67360

067649-65-4

Mono-n-dodecyltin tris(isooctyl mercaptoacetate)

SML(T) = 0,05 mg/kg food ( 41 ) (as sum of mono-n-dodecyltin tris(isooctyl mercaptoacetate), di-n- dodecyltin bis(isooctyl mercaptoacetate), mono-dodecyltin trichloride and di-dodecyltin dichloride) expressed as the sum of mono- and di-dodecyltin chloride’

(c)

The following additives are deleted:

Ref. No

CAS No

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

‘67180

—

Mixture of (50 % w/w) phthalic acid n-decyl n-octyl ester, (25 % w/w) phthalic acid di-n-decyl ester, (25 % w/w) phthalic acid di-n- octyl ester.

SML = 5 mg/kg ( 1 )

76681

—

Polycyclopentadiene, hydrogenated

SML = 5 mg/kg ( 1 )’

ANNEX IV

ANNEX IV

‘ANNEX IVa

LIPOPHILIC SUBSTANCES FOR WHICH THE FRF APPLIES

Ref. No

CAS No

Name

31520

061167-58-6

Acrylic acid, 2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-methylphenyl ester

31530

123968-25-2

Acrylic acid, 2,4-di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl]phenyl ester

31920

000103-23-1

Adipic acid, bis(2-ethylhexyl) ester

38240

000119-61-9

Benzophenone

38515

001533-45-5

4,4′-Bis(2-benzoxazolyl)stilbene

38560

007128-64-5

2,5-Bis(5-tert-butyl-2-benzoxazolyl)thiophene

38700

063397-60-4

Bis(2-carbobutoxyethyl)tin-bis(isooctyl mercaptoacetate)

38800

032687-78-8

N,N′-Bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazide

38810

080693-00-1

Bis(2,6-di-tert-butyl-4-methylphenyl)pentaerythritol diphosphite

38820

026741-53-7

Bis(2,4-di-tert-butylphenyl)pentaerythritol diphosphite

38840

154862-43-8

Bis(2,4-dicumylphenyl)pentaerythritoldiphosphite

39060

035958-30-6

1,1-Bis(2-hydroxy-3,5-di-tert-butylphenyl)ethane

39925

129228-21-3

3,3-Bis(methoxymethyl)-2,5-dimethylhexane

40000

000991-84-4

2,4-Bis(octylmercapto)-6-(4-hydroxy-3,5-di-tert-butylanilino)-1,3,5-triazine

40020

110553-27-0

2,4-Bis(octylthiomethyl)-6-methylphenol

40800

013003-12-8

4,4′-Butylidene-bis(6-tert-butyl-3-methylphenyl-ditridecyl phosphite)

42000

063438-80-2

(2-Carbobutoxyethyl)tin-tris(isooctyl mercaptoacetate)

45450

068610-51-5

p-Cresol-dicyclopentadiene-isobutylene, copolymer

45705

166412-78-8

1,2-cyclohexanedicarboxylic acid, diisononyl ester

46720

004130-42-1

2,6-Di-tert-butyl-4-ethylphenol

47540

027458-90-8

Di-tert-dodecyl disulphide

47600

084030-61-5

Di-n-dodecyltin bis(isooctyl mercaptoacetate)

48800

000097-23-4

2,2′-Dihydroxy-5,5′-dichlorodiphenylmethane

48880

000131-53-3

2,2′-Dihydroxy-4-methoxybenzophenone

49485

134701-20-5

2,4-Dimethyl-6-(1-methylpentadecyl)-phenol

49840

002500-88-1

Dioctadecyl disulphide

51680

000102-08-9

N,N′-Diphenylthiourea

52320

052047-59-3

2-(4-Dodecylphenyl)indole

53200

023949-66-8

2-Ethoxy-2′-ethyloxanilide

54300

118337-09-0

2,2′-Ethylidenebis(4,6-di-tert-butyl phenyl) fluorophosphonite

59120

023128-74-7

1,6-Hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide)

59200

035074-77-2

1,6-Hexamethylene-bis(3-(3,5-di-tert-butyl–4-hydroxyphenyl)propionate)

60320

070321-86-7

2-[2-Hydroxy-3,5-bis(1,1-dimethylbenzyl)phenyl]benzotriazole

60400

003896-11-5

2-(2′-Hydroxy-3′-tert-butyl-5′-methylphenyl)-5-chlorobenzotriazole

60480

003864-99-1

2-(2′-Hydroxy-3,5′-di-tert-butylphenyl)-5-chlorobenzotriazole

61280

003293-97-8

2-Hydroxy-4-n-hexyloxybenzophenone

61360

000131-57-7

2-Hydroxy-4-methoxybenzophenone

61600

001843-05-6

2-Hydroxy-4-n-octyloxybenzophenone

66360

085209-91-2

2,2′-Methylene bis(4,6-di-tert-butylphenyl) sodium phosphate

66400

000088-24-4

2,2′-Methylene bis(4-ethyl-6-tert-butylphenol)

66480

000119-47-1

2,2′-Methylene bis(4-methyl-6-tert-butylphenol)

66560

004066-02-8

2,2′-Methylene bis(4-methyl-6-cyclohexylphenol)

66580

000077-62-3

2,2′-Methylene bis(4-methyl-6-(1-methyl-cyclohexyl) phenol)

68145

080410-33-9

2,2′,2′-Nitrilo[triethyl tris(3,3′,5,5′-tetra-tert-butyl-1,1′-bi-phenyl-2,2′-diyl)phosphite]

68320

002082-79-3

Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

68400

010094-45-8

Octadecylerucamide

69840

016260-09-6

Oleylpalmitamide

71670

178671-58-4

Pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate)

72081/10

—

Petroleum Hydrocarbon Resins (hydrogenated)

72160

000948-65-2

2-Phenylindole

72800

001241-94-7

Phosphoric acid, diphenyl 2-ethylhexyl ester

73160

—

Phosphoric acid, mono- and di-n-alkyl (C 16 and C 18 ) esters

74010

145650-60-8

Phosphorous acid, bis(2,4-di-tert-butyl-6-methylphenyl) ethyl ester

74400

—

Phosphorous acid, tris(nonyl- and/or dinonylphenyl) ester

76866

—

Polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, also end-capped with acetic acid or fatty acids C 12 -C 18 or n-octanol and/or n-decanol

77440

—

Polyethyleneglycol diricinoleate

78320

009004-97-1

Polyethyleneglycol monoricinoleate

81200

071878-19-8

Poly[6-[(1,1,3,3-tetramethylbutyl)amino]-1,3,5-triazine-2,4-diyl]-[(2,2,6,6-tetramethyl-4-piperidyl)-imino]hexamethylene[(2,2,6,6-tetramethyl-4-piperidyl)imino]

83599

068442-12-6

Reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltin

83700

000141-22-0

Ricinoleic acid

84800

000087-18-3

Salicylic acid, 4-tert-butylphenyl ester

92320

—

Tetradecyl-polyethyleneglycol(EO=3-8) ether of glycolic acid

92560

038613-77-3

Tetrakis(2,4-di-tert-butyl-phenyl)-4,4′-biphenylylene diphosphonite

92700

078301-43-6

2,2,4,4-Tetramethyl-20-(2,3-epoxypropyl)-7-oxa-3,20-diazadispiro[5.1.11.2]-heneicosan-21-one, polymer

92800

000096-69-5

4,4′-Thiobis(6-tert-butyl-3-methylphenol)

92880

041484-35-9

Thiodiethanol bis(3-(3,5-di-tert-butyl-4-hydroxy phenyl) propionate)

93120

000123-28-4

Thiodipropionic acid, didodecyl ester

93280

000693-36-7

Thiodipropionic acid, dioctadecyl ester

95270

161717-32-4

2,4,6-Tris(tert-butyl)phenyl-2-butyl-2-ethyl-1,3-propanediol phosphite

95280

040601-76-1

1,3,5-Tris(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

95360

027676-62-6

1,3,5-Tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

95600

001843-03-4

1,1,3-Tris(2-methyl-4-hydroxy-5-tert-butylphenyl) butane’

ANNEX V

ANNEX V

Annex V to Directive 2002/72/EC is amended as follows:

(1)

Part A is replaced by the following:

‘Part A:   General specifications

Plastic material and articles shall not release primary aromatic amines in a detectable quantity (DL = 0,01 mg/kg of food or food simulant). The migration of the primary aromatic amines appearing in the lists in Annex II and III is excluded from this restriction.’

(2)

In Part B, the following new specifications are inserted, in the appropriate numerical order:

Ref. No

OTHER SPECIFICATIONS

‘42080

Carbon black

Specifications:

—

Toluene extractables: maximum 0,1 %, determined according to ISO method 6209.

—

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 generally recognised method of analysis.

—

Benzo(a)pyrene content: max 0,25 mg/kg carbon black.

—

Maximum use level of carbon black in the polymer: 2,5 % w/w

72081/10

Petroleum hydrocarbon resins (hydrogenated)

Specifications:

Petroleum hydrocarbon resins, hydrogenated are produced by the catalytic or thermal polymerisation of dienes and olefins of the aliphatic, alicyclic and/or monobenzenoid arylalkene types from distillates of cracked petroleum stocks with a boiling range not greater than 220 °C, as well as the pure monomers found in these distillation streams, subsequently followed by distillation, hydrogenation and additional processing.

Properties:

Viscosity: > 3 Pa.s at 120 °C.

Softening point: > 95 °C as determined by ASTM Method E 28-67.

Bromine number: < 40 (ASTM D1159)

The colour of a 50 % solution in toluene < 11 on the Gardner scale

Residual aromatic monomer ≤ 50 ppm

76845

Polyester of 1,4-butanediol with caprolactone

MW fraction < 1 000 is less than 0,5 % (w/w)

81500

Polyvinylpyrrolidone

The substance shall meet the purity criteria established in Commission Directive 96/77/EC  ( *1 )

88640

Soybean oil, epoxidized

Oxirane < 8 %, iodine number < 6

( *1 )

OJ L 339, 30.12.1996, p. 1 .’

ANNEX VI

ANNEX VI

Annex VI to Directive 2002/72/EC is amended as follows:

(1)

Note ( 8 ) is replaced by the following:

‘( 8 )

SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 24886, 38000, 42400, 62020, 64320, 66350, 67896, 73040, 85760, 85840, 85920 and 95725.’

(2)

The following notes 41 and 42 are added:

‘( 41 )

SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 47600, 67360.

( 42 )

SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 75100 and 75105.’

ANNEX VII

ANNEX VII

‘ANNEX VIa

DECLARATION OF COMPLIANCE

The written declaration referred to in Article 9 shall contain the following information:

(1)

the identity and address of the business operator which manufactures or imports the plastic materials or articles or the substances intended for the manufacturing of those materials and articles;

(2)

the identity of the materials, the articles or the substances intended for the manufacturing of those materials and articles;

(3)

the date of the declaration;

(4)

confirmation that the plastic materials or articles meet relevant requirements laid down in this Directive and Regulation (EC) No 1935/2004;

(5)

adequate information relative to the substances used for which restrictions and/or specifications are in place under this Directive to allow the downstream business operators to ensure compliance with those restrictions;

(6)

adequate information relative to the substances which are subject to a restriction in food, obtained by experimental data or theoretical calculation about the level of their specific migration and, where appropriate, purity criteria in accordance with Directives 95/31/EC, 95/45/EC and 96/77/EC to enable the user of these materials or articles to comply with the relevant Community provisions or, in their absence, with national provisions applicable to food;

(7)

specifications on the use of the material or article, such as:

(i)

type or types of food with which it is intended to be put in contact;

(ii)

time and temperature of treatment and storage in contact with the food;

(iii)

ratio of food contact surface area to volume used to establish the compliance of the material or article;

(8)

when a plastic functional barrier is used in a plastic multi-layer material or article, the confirmation that the material or article complies with the requirements of Article 7a(2), (3) and 4 of this Directive.

The written declaration shall permit an easy identification of the materials, articles or substances for which it is issued and shall be renewed when substantial changes in the production bring about changes in the migration or when new scientific data are available.’

ANNEX VIII

ANNEX VIII

The Annex to Directive 85/572/EEC is amended as follows:

(1)

Point 3 is replaced by the following:

‘3.

When “X” is followed by an oblique stroke and a figure, the result of the migration tests should be divided by the figure indicated. In the case of certain types of fatty food, this conventional figure, known as “Simulant D Reduction Factor” (DRF), is used to take account of the greater extractive capacity of the simulant compared to the food.’

(2)

The following point 4a is inserted:

‘4a.

Where the letter (b) is shown in brackets after the “X”, the indicated test shall be carried out with ethanol 50 % (v/v).’

(3)

In the table, Section 07 is replaced by the following:

‘07

Milk products

07.01

Milk:

A.

Whole

X(b)

B.

Partly dried

X(b)

C.

Skimmed or partly skimmed

X(b)

D.

Dried

07.02

Fermented milk such as yoghurt, buttermilk and similar products

X

X(b)

07.03

Cream and sour cream

X(a)

X(b)

07.04

Cheeses:

A.

Whole, with non-edible rind

B.

All others

X(a)

X(a)

X/3*

07.05

Rennet

A.

In liquid or viscous form

X(a)

X(a)

B.

Powdered or dried’