2002 No. 2834 (W.272)

FOOD, WALES

The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2002

Made

Coming into force

In exercise of the powers conferred by sections 16(2), 17(1), 26(1)(a), 31 and 48(1) of the Food Safety Act 1990F1, which are now exercisable in relation to Wales by the National Assembly for WalesF2 having regard in accordance with section 48(4A) of that Act to relevant advice given by the Food Standards Agency and after consultation as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safetyF3, and after consultation in accordance with section 48(4) and 4(B) of that Act, makes the following Regulations:

Annotations:
Amendments (Textual)
F2

Functions of “the Secretary of State” so far as exercisable in relation to Wales were transferred to the National Assembly for Wales by S.I. 1999/672, as amended by s.40(3) of the Food Standards Act 1999 (1999 c.28).

F3

OJ No. L31, 1.2.2002, p1.

Title, commencement and application1

1

These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2002 and shall come into force on 30th November 2002.

2

These Regulations apply to Wales only.

Amendments to the Plastic Materials and Articles in Contact with Food Regulations 19982

The Plastic Materials and Articles in Contact with Food Regulations 1998 F4 (“the principal Regulations”) shall be amended, in so far as they apply to Wales, in accordance with regulations 3 to 18.

3

Immediately after regulation 1 there shall be added the following regulation—

Scope of these Regulations1A

Notwithstanding the title to these Regulations—

a

regulations 3 and 9 to 12 apply also in relation to adhesives and to materials or articles covered by surface coatings; and

b

regulation 8A and regulation 8B apply only in relation to adhesives and to materials or articles covered by surface coatings.

4

In regulation 2 (interpretation)—

a

in paragraph (1)—

i

immediately after the definitions of “additive” there shall be inserted the following definitions—

“adhesive” means anything which, for the purposes of Commission Directive 2002/16, is included among the adhesives to which that Directive applies;

“BADGE” means 2,2-bis(4-hydroxyphenyl) propane bis(2,3-epoxypropyl) ether;

“BFDGE” means bis(hydroxyphenyl) methane bis(2,3-epoxypropyl) ethers;

ii

for the definition of “capable” there shall be substituted the following definition—

“capable” means capable as established—

a

in relation to any plastic material or article, under regulation 6; and

b

in relation to any adhesive or material or article covered by a surface coating, under regulation 8B;

iii

immediately after the definition of “capable” there shall be inserted the following definitions—

“Commission Directive 2001/62” means Commission Directive 2001/62/EC amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs F5;

“Commission Directive 2002/16” means Commission Directive 2002/16/EC on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs F6;

iv

For the definition of “the Directive” there shall be substituted the following definition - “ “the Directive” means Commission Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs F7; ”,

v

immediately after the definition of “import” there shall be inserted the following definition—

“material or article covered by a surface coating” means anything which, for the purposes of Commission Directive 2002/16, is included among the materials and articles covered by surface coatings to which that Directive applies;

vi

immediately after the definition of “monomer” there shall be inserted the following definition—

“NOGE” means novolac glycidyl ethers not covered by Article 1(a) or (b) of Commission Directive 2002/16;

vii

at the end of the definition of “plastic material or article” there shall be added the following words “ , except that, where it is used in any provisions referred to in paragraph (5) below, to the extent that they implement or relate to the enforcement of Commission Directive 2002/16, it means any material or article made of any type of plastic ”; and

viii

after the definition of “sell” there shall be added the following definition—

“QMA” has the same meaning as it bears in the first sentence of the sub-paragraph relating to that term in paragraph 8 of Annex II to the Directive;

b

for paragraph (2) there shall be substituted the following provision—

2

For the purposes of these Regulations, the supply in the course of a business, otherwise than on sale, of any plastic material or article, adhesive or material or article covered by a surface coating, shall be deemed to be a sale of the plastic material or article, adhesive or material or article covered by a surface coating concerned.

and

c

immediately after paragraph (4) there shall be inserted the following paragraph—

5

The provisions referred to in the definition of “plastic material or article” in paragraph (1) of this regulation are regulations 3, 4, 4A, 5, 6, 10, 11 and 12 and Schedules 3 and 4.

Annotations:
Amendments (Textual)
F5

OJ No. L221, 17.8.2001, p.18.

F6

OJ No. L215, 9.8.2001, p.26.

F7

OJ No. L220, 15.8.2002, p.18.

5

In regulation 3 (restriction on the use, sale or importation of plastic materials and articles)—

a

for the heading there shall be substituted the following heading—

Restriction on the use, sale or importation of plastic materials and articles, adhesives and materials and articles covered by surface coatings

b

in paragraphs (1) and (2), immediately after the references to “plastic material or article”, wherever they appear, there shall be inserted references to “ , adhesive or material or article covered by a surface coating ”;

c

in sub-paragraph (4)(a)(iii) the word “or” shall be deleted;

d

for sub-paragraph (4)(a)(iv) there shall be substituted the following sub-paragraph—

iv

it does not comply with regulation 4(5), (5A) or (5B), 4A(4), (5) or (6), 5(4), (4A), (4B) or (4C), 7 or 7A(1) or 8A(4), (5) or (6); or

and

e

immediately after sub-paragraph (4)(a)(iv) there shall be added the following sub-paragraph—

v

it has been manufactured in contravention of a prohibition contained in regulation 4A(1), (2) or (3),

f

there shall be added at the end the following paragraph—

5

For the purposes of this regulation, an adhesive or a material or article covered by a surface coating fails to meet the requisite standards if—

i

it has been manufactured in contravention of a prohibition contained in regulation 8A(1), (2) or (3), or

ii

it does not comply with regulation 8A(4), (5) or (6).

6

In regulation 4 (restriction on manufacture with monomers)—

a

for the heading and paragraph (1) there shall be substituted the following provisions—

Restriction on manufacture with monomers of plastic materials and articles

1

Subject to the following paragraphs of this regulation, no person shall use in the manufacture of any plastic material or article any prohibited monomer, that is to say—

a

any monomer (not being one to which sub-paragraph (b) or (c) below relates) which is not—

i

of good technical quality;

ii

identified by PM/REF No. , CAS No. (if any) and name in columns 1, 2 and 3 respectively of the relevant section of Part I of Schedule 1, and

iii

used in accordance with the restrictions and specifications (if any) for that monomer set out or referred to in the corresponding entry in column 4 of that section;

b

BFDGE to the extent that they are used in such manufacture—

i

on or after 1st January 2005, or

ii

prior to that date in contravention of the restriction specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex; or

c

NOGE to the extent that it is used in such manufacture—

i

on or after 1st January 2005, or

ii

prior to that date but on or after 1st March 2003, in contravention of the restriction specified in the first sentence of Article 4 of Commission Directive 2002/16.

b

in paragraph (2)—

i

for sub-paragraph (b) there shall be substituted the following provisions - “ in the case of a plastic material or article manufactured on or after 30th November 2002 and before 1st January 2005, Section A or B ”, and

ii

for sub-paragraph (c), there shall be substituted the following provisions “ in the case of a plastic material or article manufactured on or after 1st January 2005, Section A. ”;

c

for paragraph (3) there shall be substituted the following paragraph—

3

Paragraph (1)(a) of this regulation does not apply to the use of a monomer in the manufacture of any—

a

surface coatings obtained from resinous or polymerised products in liquid, powder or dispersion form, including, but not limited to, varnishes, lacquers and paints;

b

epoxy resins;

c

adhesives and adhesion promoters; or

d

printing inks.

d

in paragraph (4), for the expression “Paragraph (1)” there shall be substituted the expression “ Paragraph (1)(a) ”;

e

immediately after paragraph (5) there shall be inserted the following paragraphs—

5A

No plastic material or article manufactured using BFDGE as a monomer shall be capable of transferring constituents of that monomer to food with which that plastic material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.

5B

On or after 1st March 2003, no plastic material or article manufactured using NOGE as a monomer shall fail to comply with the requirements of the first sentence of Article 4 of Commission Directive 2002/16.

and

f

in paragraph (7)—

i

for the expression “paragraph (1)” there shall be substituted the expression “ paragraph (1)(a) ”, and

ii

after the words “Part I of Schedule 1” there shall be inserted the words “ or to which sub-paragraph (b) or (c) of that paragraph relates ”.

7

Immediately after regulation 4 (restriction on manufacture with monomers) there shall be inserted the following regulation—

Restriction on manufacture of plastic materials and articles using certain substances other than as monomers or additives4A

1

No person shall use BADGE in the manufacture of any plastic material or article, where the use is not as a monomer or an additive—

a

on or after 1st January 2005; or

b

prior to that date in contravention of the restriction specified in paragraph 1 of Annex 1 to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.

2

No person shall use BFDGE in the manufacture of any plastic material or article, where the use is not as a monomer or an additive—

a

on or after 1st January 2005; or

b

prior to that date in contravention of the restriction specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.

3

No person shall use NOGE in the manufacture of any plastic material or article, where the use is not as a monomer or additive—

a

on or after 1st January 2005; or

b

prior to that date but on or after 1st March 2003, in contravention of the restriction specified in the first sentence of Article 4 of Commission Directive 2002/16.

4

No plastic material or article manufactured using BADGE other than as a monomer or an additive shall be capable of transferring constituents of BADGE to food with which the plastic material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex I to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.

5

No plastic material or article manufactured using BFDGE other than as a monomer or an additive shall be capable of transferring constituents of BFDGE to food with which the plastic material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.

6

On and after 1st March 2003, no plastic material or article manufactured using NOGE other than as a monomer or an additive shall fail to comply with the requirements of the first sentence of Article 4 of Commission Directive 2002/16.

8

In regulation 5 (restriction on manufacture with additives)—

a

for the heading and paragraph (1) there shall be substituted the following provisions—

Restriction on manufacture of plastic materials and articles with additives

1

Subject to the following paragraphs of this regulation, no person shall use in the manufacture of plastic material or article any prohibited additive, that is to say—

a

any additive identified by PM/REF No. , CAS No. (if any) and name in columns 1, 2 and 3 respectively of Part I of Schedule 2 or columns 1, 2 and 3 respectively of Part II of that Schedule, which is not—

i

of good technical quality, and

ii

used in accordance with the restrictions and specifications (if any) for that additive set out in the corresponding entry in column 4 of Part I or Part II, as appropriate;

b

BADGE to the extent that it is used in such manufacture—

i

on or after 1st January 2005, or

ii

prior to that date in contravention of the restriction specified in paragraph 1 of Annex I to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex;

c

BFDGE which is used in such manufacture—

i

on or after 1st January 2005, or

ii

prior to that date in contravention of the restriction specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex; or

d

NOGE not otherwise covered by this paragraph and which is used in such manufacture—

i

on or after 1st January 2005, or

ii

prior to that date but on or after 1st March 2003, in contravention of the restriction specified in the first sentence of Article 4 of Commission Directive 2002/16.

b

in paragraph (2), immediately after the expression “Part I” there shall be added the expression “ or Part II ”;

c

for paragraph (3), there shall be substituted the following paragraph—

3

Part III of Schedule 2 shall have effect to supplement this regulation and Parts I and II of that Schedule.

d

in paragraph (4)—

i

for the expression “Part I of Schedule 2” there shall be substituted the expression “ Part I or Part II of Schedule 2, ”, and

ii

in each of sub-paragraphs (a) and (b), for the word “therein” there shall be substituted the expression “ that column ”.

e

between paragraphs 4 and 5 there shall be inserted the following paragraphs—

4A

No plastic material or article manufactured using BADGE as an additive shall be capable of transferring constituents of that additive to food with which the plastic material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex I to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.

4B

No plastic material or article manufactured using BFDGE as an additive shall be capable of transferring constituents of that additive to food with which the plastic material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.

4C

On and after 1st March 2003, no plastic material or article manufactured using NOGE as an additive shall fall to comply with the requirements of the first sentence of Article 4 of Commission Directive 2002/16.

and

f

in paragraph (5), for the expression “Part I of Schedule 2” there shall be substituted the expression “ Part I or Part II of Schedule 2, ”.

9

n regulation 6 (method of testing capability of transferring constituents)—

a

for the heading, the introductory words and paragraph (1)(a) there shall be substituted the following heading—

Method of testing the capability of plastic materials or articles of transferring constituents and methods of analysis;

1

For the purposes of these Regulations, a plastic material or article shall be treated as being capable of transferring constituents other than NOGE to food with which it may come into contact to the extent that such capability is established—

a

in any case other than one to which sub-paragraph (b) below relates, and subject to Article 8.4 of Commission Directive 2001/62 (which may be applied on compliance with the conditions stated therein) by the verification methods specified in Schedules 3 and 4;

and

b

after paragraph (3) there shall be added the following provisions—

The specific migration from a plastic material or article shall, where applicable, be determined in the manner specified in the relevant sub-division of paragraph 8 of the Annex to the Directive.

5

The specific migration from a plastic material or article of the substances listed in paragraph 1 of Annex I to Commission Directive 2002/16 shall be determined in the manner specified in paragraph 3 of that Annex.

6

The specific migration from a plastic material or article of the substances listed in paragraph 1 of Annex II to Commission Directive 2002/16 shall be determined in the manner specified in paragraph 3 of that Annex.

7

Whether or not the detection requirement specified in Article 4 of Commission Directive 2002/16 is complied with in relation to a plastic material or article shall be determined in the manner specified in the second sentence of that Article.

8

The quantity of a constituent in a plastic material or article shall, where applicable, be determined in the manner specified in the sub-paragraph of paragraph 8 of Annex II to the Directive relating to the term “QM(T)” or, as the case may be, the sub-paragraph of that paragraph relating to the term “QMA”.

10

For regulation 7A (specifications) there shall be substituted the following regulation—

Specifications7A

1

Subject to paragraph (3), no plastic material or article manufactured using isocyanates or colourants prepared by diazo-coupling shall be capable of transferring primary aromatic amines (expressed as aniline), not being primary aromatic amines listed in these Regulations, to food with which that plastic material or article may come into contact.

2

Schedule 2B shall have effect for the purpose of prescribing, for certain items listed in Part I of Schedule 1, Part I or II of Schedule 2 or Schedule 2A, the specifications for those items which are referred to in column 4 of the Part or, as the case may be, Schedule concerned.

3

For the purposes of paragraph (1), “detectable quantity” means a quantity of at least DLO.02 milligrams per kilogram of food or food simulant (analytical tolerance included).

11

Immediately after regulation 8 (labelling) there shall be inserted the following regulations—

Restriction on manufacture with certain substances of adhesives materials and articles covered by surface coatings and adhesives8A

1

No person shall (in any case not covered by Article 1(2) of Commission Directive 2002/16) use BADGE in the manufacture of any—

a

adhesive; or

b

material or article covered by a surface coating.

on or after 1st January 2005, or prior to that date, in contravention of the restriction specified in paragraph 1 of Annex 1 to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.

2

No person shall (in any case not covered by Article 1.2 of Commission Directive 2002/16) use BFDGE in the manufacture of any—

a

adhesive; or

b

material or article covered by a surface coating

on or after 1st January 2005, or prior to that date in contravention of the restriction specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.

3

No person shall (in any case not covered by Article 1(2) of Commission Directive 2002/16) use NOGE in the manufacture of any—

a

adhesive; or

b

material or article covered by a surface coating

on or after 1st January 2005, or prior to that date but, on or after 1st March 2003, in contravention of the restriction specified in the first sentence of Article 4 of Commission Directive 2002/16.

4

No adhesive, or material or article covered by a surface coating, manufactured using BADGE and not covered by Article 1(2) of Commission Directive 2002/16, shall be capable of transferring constituents of BADGE to food with which the adhesive or, as the case may be, material or article, may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex 1 to that Directive, as read with the second sentence of paragraph 2 of that Annex.

5

No adhesive, or material or article covered by a surface coating, manufactured using BFDGE and not covered by Article 1(2) of Commission Directive 2002/16, shall be capable of transferring constituents of BFDGE to food with which that adhesive or, as the case may be, material or article, may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex II to that Directive, as read with the second sentence of paragraph 2 of that Annex.

6

On and after 1st March 2003, no adhesive, or material or article covered by a surface coating, manufactured using NOGE and not covered by Article 1(2) of Commission Directive 2002/16, shall fail to comply with the requirements of the first sentence of Article 4 of that Directive.

Method of testing the capability of materials or articles covered by surface coatings and adhesives of transferring constituents and methods of analysis8B

1

Subject to paragraphs (2) and (3) of this regulation, for the purposes of regulation 8A(1), (2), (4) and (5) an adhesive or a material or article covered by a surface coating shall be treated as being capable of transferring BADGE or, as the case may be, BFDGE to food with which it may come into contact to the extent that it is established for those purposes by the verification methods specified in Section A or Schedule 3 and in Schedule 4.

2

Subject to paragraph (3) of this regulation, in Section A of Schedule 3 and in Schedule 4, references to migration or release of a substance shall be construed as references to the transfer of constituents to the simulant representing the food or, as the case may be, the food with which the substance may come into contact.

3

For the purposes of paragraphs (1) and (2) of this regulation, Schedules 3 and 4 shall have effect as if—

a

the references in Section A of Schedule 3 and in Schedule 4 to “a plastic material or article” were references to “an adhesive or a material or article covered by a surface coating”; and

b

the references in paragraph 4(3) and (4) of Section A of Schedule 3 to “regulation 7, Schedule 1 or Schedule 2” were references to “a migration limited referred to in regulation 8A(4) or (5)”; and

c

the reference in paragraph 5 of Part II of Schedule 4 and paragraph 2(1)(b) of Part III of that Schedule to “regulation 7 or Schedule 1” were a reference to “regulation 8A(4) or (5)”.

4

The specific migration from an additive or a material or article covered by a surface coating of the substances listed in paragraph 1 of Annex I to Commission Directive 2002/16 shall be determined in the manner specified in paragraph 3 of that Annex.

5

The specific migration from an adhesive or a material or article covered by a surface coating of the substances listed in paragraph 1 of Annex II to Commission Directive 2002/16 shall be determined in the manner specified in paragraph 3 of that Annex.

6

Whether or not the detection limit specified in Article 4 of Commission Directive 2002/16 is complied with in relation to an adhesive or a material or article covered by a surface coating shall be determined in the manner specified in the second and third sentences of that Article.

12

In regulation 10 (offences)—

a

in paragraph (1), for the expression “regulation 3, 4(1), 5(1) or 8” there shall be substituted the expression “ 3, 4(1), 4A(1), (2) or (3), 5(1), 8 or 8A(1), (2) or (3) ”;

b

in each of paragraphs (9) and (10), immediately after the words “plastic material or article” there shall be inserted the words “ or, as the case may be, adhesive or material or article covered by a surface coating, ”; and

c

immediately after paragraph (15) there shall be added the following paragraphs—

16

Subject to paragraph (18) of this regulation, in any proceedings for an offence under these Regulations, it shall be a defence to prove that—

a

the act constituting the offence was committed in relation to a plastic material or article which was put into circulation in the European Community before 30th November 2002; and

b

the matter constituting the offence would not have constituted an offence under these Regulations if the amendments made to them by the provisions referred to in paragraph (17) below had not been in force at the time that matter occurred.

17

The provisions referred to in paragraph (16) of this regulation are regulations 5(d), 6(b), 8(a), (b) and (d), 10, 12(a) and 15 to 17 of the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2002 which implement or provide for the enforcement of the requirements of Commission Directive 2001/62 to which Article 2 of that Directive applies.

18

For the purposes of paragraph (16) of this regulation, “free circulation” shall have the same meaning as in Article 2 of Commission Directive 2001/62.

19

In any proceedings for an offence under these Regulations, it shall be a defence to prove that—

a

the act constituting the offence consisted was the sale of an adhesive or a material or article covered by a surface coating—

i

which was brought into contact with food before 28th February 2003,

ii

on which (in the case of a material or article covered by a surface coating) the date of filling appeared at the time of sale; and

iii

the labelling or marking of which at the time of sale (in the case of a material or article covered by a surface coating) complied with the requirement as regards labelling relating to durability contained in Article 2.1(a) of Directive 2000/13/EC of the European Parliament and the Council on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs F8;

b

the sale would not have constituted an offence under these Regulations if the amendments made to them by the provisions referred to in paragraph (20) below had not been in force at the time of sale.

20

The provisions referred to in paragraph (18) above are regulations 5(b) and (f), 8A and 12(a) of those provisions of the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2002

Annotations:
Amendments (Textual)
F8

OJ No. L109, 6.5.2000, p.29.

13

In regulation 11 (presumption as to food with which a plastic material or article is to come into contact) and the heading thereto, immediately after the words “plastic material or article”, wherever they appear, there shall be inserted the words “ , adhesive or material or article covered by a surface coating, ”.

14

In regulation 12 (application of other provisions)—

a

in paragraph (1), after the words “plastic materials or articles” there shall be added the words “ , adhesives and materials or articles covered by a surface coating ”; and

b

in paragraph (3), for the words “relate to plastic materials or articles” there shall be substituted the words “ apply to plastic materials or articles, adhesives or materials or articles covered by a surface coating ”.

15

In Schedule 1 (monomers authorised without time limit, monomers authorised up to the end of 2001, monomers authorised up to the end of 1998 and supplementary)—

a

in Section A of Part I—

i

in the case of each monomer listed in Part I of Schedule 1 to these Regulations, the item number and letter, PM/REF No. CAS No. (if any), name and restriction or specification specified for that monomer in that Part shall be inserted in the appropriate numerical position for that item number and letter,

ii

in the case of each monomer named in the second column of Part II of Schedule 1 to these Regulations, for the item number and letter for that monomer specified opposite to it in the first column (item) there shall be substituted the item number and letter for it specified in the first column (item) of that Part, and

iii

in the case of each monomer named in the first column of Part III of Schedule 1 to these Regulations, for the entry for that monomer specified opposite to it in column 4 (restrictions and specifications) there shall be substituted the entry for it specified in the second column (restrictions and specifications) of that Part;

b

for Section B of Part I there shall be substituted the contents of Part IV of Schedule 1 to these Regulations; and

c

in Part II, for paragraph 4 there shall be substituted the following paragraph—

4

Where an entry in column 4 of Part I of this Schedule (restrictions and specifications) includes a bracketed number, that entry shall be subject to a note relating to that number as follows, the following bracketed numbers corresponding with those appearing in that Part:

1

Warning: there is a risk that the specific migration limit could be exceeded in fatty food simulants.

2

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 10060 and 23920.

3

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 15760, 16990, 47680, 53650 and 89440.

4

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 19540, 19960 and 64800.

5

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 14200, 14230 and 41840.

14

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 15970, 48640, 48720, 48880, 61280, 61360 and 61600.

21

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 17260 and 18670.

16

In Schedule 2 (additives and supplementary)—

a

In Part I—

i

for the heading “Part I Additives” there shall be substituted the heading “ Part I: Incomplete list of additives used in the manufacture of plastic materials and articles (not being additives to which paragraph 5 of Part III of this Schedule applies) ”,

ii

in the case of each additive listed in Part I of Schedule 2 to these Regulations, the item number and letter, PM/REF No. , CAS No. (if any), name and restriction or specification (if any) specified for that additive in that Part shall be inserted in the appropriate numerical position for that item number and letter,

iii

in the case of each additive named in the second column of Part II of Schedule 2 to these Regulations, for the item number for that additive specified opposite to it in the column headed “Item” there shall be substituted the item number for it specified in the first column (item) of that Part,

iv

in the case of each additive named in the first column of Part III of Schedule 2 to these Regulations, for the entry for that additive specified opposite to it in column 4 (restrictions and specifications) there shall be substituted the entry for it specified in the second column (restrictions and specifications) of that Part, and

v

all the entries for the additive Silicic acid, salts, (item 241) shall be deleted;

b

immediately after Part I there shall be inserted the contents of Part IV of Schedule 2 to these Regulations (which shall become Part II of Schedule 2 to the principal Regulations on the coming into force of these Regulations);

c

in Part II—

i

in the heading, for the expression “Part II” there shall be substituted the expression “ Part III ”;

ii

in paragraph 1, for the expression “Part I” there shall be substituted the expression “ Parts I and II ”;

iii

in each of paragraphs 2, 3 and 4, immediately after the expression “Part I” there shall be added the expression “ or Part II ”; and

iv

for paragraph 4 there shall be substituted the following paragraph—

4

Where an entry in column 4 of Part I or in column 4 of Part II of this Schedule (in each case restrictions and specifications) includes a bracketed number, that entry shall be subject to a note relating to that number as follows, the following bracketed numbers corresponding with those appearing in those Parts:

1

Warning: there is a risk that the SML could be exceeded in fatty food simulants.

2

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 10060 and 23920.

3

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 15760, 16990, 47680, 53650 and 89440.

4

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 19540, 19960 and 64800.

5

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 14200, 14230 and 41840.

6

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 66560 and 66580.

7

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 30080, 42320, 45195, 45200, 53610, 81760, 89200 and 92030.

8

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 42400, 64320, 73040, 85760, 85840, 85920 and 95725.

9

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and 73120.

10

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 45200, 64320, 81680 and 86800.

11

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 36720, 36800 and 92000.

12

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 39090 and 39120.

13

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 44960, 68078, 82020 and 89170.

14

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 15970, 48640, 48720, 48880, 61280, 61360 and 61600.

15

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 49600, 67520 and 83599.

16

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 and 51120.

17

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 67600, 67680 and 67760.

18

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 60400, 60480 and 61440.

19

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 66400 and 66480.

20

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 93120 and 93280.

21

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 17260 and 18670.

and

d

immediately after paragraph 4 there shall be added the following paragraph—

5

In the case of the substances listed in Part II of this Schedule, the specific migration limits specified in column 4 of that Part (restrictions and specifications) shall have effect from 1st January 2004 where the verification of compliance is carried out in simulant D or in test media of substitute tests as prescribed in Council Directive 82/711/EECF9 and Council Directive 85/572/EECF10.

Annotations:
Amendments (Textual)
F9

OJ No. L297, 23.10.82, p.26, last amended by Commission Directive 97/48/EC (OJ No. L222, 12.8.97, p.10).

F10

OJ No. L372, 31.12.85, p.14.

17

In Schedule 2B (specifications) in the case of each substance listed in Schedule 3 to these Regulations, the item number and letter, PM/REF No. and specification set out for that substance in that Schedule shall be inserted in the appropriate numerical position for that item number and letter.

18

In Schedule 3 (provisions applicable when testing compliance with the migration limits)—

a

in each of sub-paragraphs (3) and (4) of paragraph 4, after the words “specified in regulation” there shall be inserted the expression “ 4(5A), 4A(4) or (5), 5(4A) or (4B), or ”; and

b

for sub-paragraph (2)(b) of paragraph 8 there shall be substituted the following sub-paragraph—

b

12 mg/kg or, as the case may be, 2 milligrams per square decimeter in migration tests using other simulants referred to in Schedule 4.

Amendment of the Food Safety (Sampling and Qualifications) Regulations 199019

In Schedule 1 to the Food Safety (Sampling and Qualifications) Regulations 1990 F11 (provisions to which those Regulations do not apply) the reference in the second column, opposite the reference in the first column to the Plastic Materials and Articles in Contact with Food Regulations 1998, shall be amended in relation to Wales so as to read “S.I. 1998/1376 as amended by S.I. 2000/3162 and S.I. 2002/2834.

Annotations:
Amendments (Textual)
F11

S.I. 1990/2463; to which there are amendments not relevant to these Regulations.

Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998 F12

Rhodri MorganThe First Minister of the National Assembly

SCHEDULE 1

Regulation 15(a) and (b)

PART ILIST OF MONOMERS TO BE ADDED TO SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

Item

PM/REF No.

CAS No.

Name

Restrictions and specifications

15A

11530

00999-61-1

Acrylic acid, 2-hydroxypropyl ester

QMA = 0.05 mg/6 dm2

28B

12763

00141-43-5

2-Aminoethanol

SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer

28C

12765

84434-12-8

N-(2-aminoethyl)-beta-alanine, sodium salt

SML = 0.05 mg/kg

38A

13395

04767-03-7

2,2-Bis(hydroxymethyl) propionic acid

QMA = 0.05 mg/6 dm2

47A

13617

00080-09-1

Bisphenol S

As item 86A

49B

13810

00505-65-7

1,4-Butanediol formal

QMA = 0.05 mg/6 dm2

52A

13932

00598-32-3

3-Buten-2-ol

QMA = ND (DL = 0.02 mg/6 dm2). To be used only as a co-monomer for the preparation of polmeric additive

70A

15030

00931-88-4

Cyclooctene

SML = 0.05 mg/kg. For use only in polymers contacting foods for which simulant A is laid down in Council Directive 85/572/EEC

76A

15370

03236-53-1

1,6-Diamino-2,2, 4-trimethylhexane

QMA = 5 mg/6 dm2

76B

15400

03236-54-2

1,6-Diamino-2,4, 4-trimethylhexane

QMA = 5 mg/6 dm2

77A

15610

00080-07-9

4,4’-Dichlorodiphenyl sulphone

SML = 0.05 mg/kg

86A

16090

00080-09-01

4,4’-Dihydroxydiphenyl sulphone

SML = 0.05 mg/kg

88B

16390

00126-30-7

2,2-Dimethyl-1, 3-propanediol

SML = 0.05 mg/kg

121B

19110

04098-71-9

1-Isocyanato-3-isocyanatomethyl-3,5, 5-trimethylcyclohexane

QM(T) = 1 mg/kg in FP (as NCO)

122A

19243

00078-79-5

Isoprene

As item 145A

126A

19490

00947-04-6

Laurolactam

SML = 5 mg/kg

135A

20260

00101-43-9

Methacrylic acid, cyclohexyl ester

SML = 0.05 mg/kg

135B

20410

02082-81-7

Methacrylic acid, diester with 1, 4-butanediol

SML = 0.05 mg/kg

135D

20590

00106-91-2

Methacrylic acid, 2,3-epoxypropyl ester

QMA=0.02mg/6dm2

144A

21520

01561-92-8

Methallylsulphonic acid, sodium salt

SML = 5 mg/kg

145A

21640

00078-79-5

2-Methyl-1,3-butadiene

QM = 1 mg/kg in FP or SML = ND (DL = 0.02 mg/kg, analytical tolerance included)

145C

21765

106246-33-7

4,4’-Methylenebis (3-chloro-2, 6-diethylaniline)

QMA = 0.05 mg/6 dm2

145D

21821

00505-65-7

1,4-(Methylenedioxy) butane

As item 49B

148A

22360

01141-38-4

2,6-Naphthalenedi carboxylic acid

SML = 5 mg/kg

150A

22437

00126-30-7

Neopentylglycol

As item 88B

156A

22778

07456-68-0

4,4’-Oxybis (benzenesulphonyl azide)

QMA = 0.05 mg/6 dm2

159A

22900

00109-67-1

1-Pentene

SML = 5 mg/kg

184A

24073

000101-90-6

Resorcinol diglycidyl

QMA = 0.005 mg/g dm2. Not for ether use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer

214A

25380

Trialkyl acetic acid (C7-C17), vinyl esters (= vinyl versatate)

QMA = 0.05 mg/g dm2

215A

25450

26896-48-0

Tricyclodecanedimethanol

SML = 0.05 mg/kg

217A

25900

00110-88-3

Trioxane

SML = 0.05 mg/kg

PART IILIST OF MONOMERS FOR WHICH THE ENTRY CONTAINED IN THE FIRST COLUMN (ITEM) OF SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED

Item

Name

52B

4-tert-Butylphenol

88C

1.3 Dioxolane

121C

Isophthalic acid

135C

Methacrylic acid, 2-(dimethylamino) ethyl ester

145B

3-Methyl-1-butene

159B

Perfluoropropyl perfluorovinyl ether

214B

Triallylamine

PART III LIST OF MONOMERS FOR WHICH THE ENTRY CONTAINED IN COLUMN 4 (RESTRICTIONS AND SPECIFICATIONS) OF SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED

Name

Restrictions and specifications

2,2-Bis(4-hydroxyphenyl) propane bis(2,3-epoxypropyl) ether (= BADGE)

In any case not covered by article 1.2 of Commission Directive [ 2002/16], use must be before 1st January 2005 and be as specified in paragraph 1 of Annex I to that Directive

4,4’-Dihydroxybenzophenone

SML(T) = 6 mg/kg (14)

Formaldehyde

SML(T) = 15 mg/kg (21)

Hexamethylenetetramine

SML(T) = 15 mg/kg (expressed as formaldehyde) (21)

1,3-Phenylenediamine

SML = ND (DL = 0.02 mg/kg, analytical tolerance included)

PART IV PROVISIONS SUBSTITUTED FOR SECTION B OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

SECTION B:MONOMERS AUTHORISED UP TO THE END OF 2004

Item

PM/REF No.

CAS No.

Name

Restrictions and specifications

1

10599/90A

61788-89-4

Acids, fatty, unsaturated (C18), dimers, distilled

2

10599/91

61788-89-4

Acids, fatty, unsaturated (C18), dimers, non-distilled

3

10599/92A

68783-41-5

Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled

4

10599/93

68783-41-5

Acids, fatty, unsaturated (C18), dimers, hydrogenated, non-distilled

5

11500

00103-11-7

Acrylic acid, 2-ethylhexyl ester

6

13050

00528-44-9

1,2, 4-Benzenetricarboxylic acid

As item 23

7

13075

00091-76-9

Benzoguanamine

8

13720

00110-63-4

1,4-Butanediol

9

14260

00502-44-3

Caprolactone

10

14800

03724-65-0

Crotonic acid

11

15310

00091-76-9

2,4-Diamino-6-phenyl-1,3,5-triazine

12

15730

00077-73-6

Dicyclopentadiene

13

16210

06864-37-5

3,3’-Dimethyl-4-4’-diaminodicyclo-hexylmethane

14

16690

01321-74-0

Divinylbenzene

15

16697

00693-23-2

Dodecanedioic acid

16

17110

16219-75-3

5-Ethylidenebicyclo [2.2.1]hept-2-ene

17

18370

00592-45-0

1,4-Hexadiene

18

18700

00629-11-8

1,6-Hexanediol

19

21370

10595-80-9

Methacrylic acid, 2-sulphoethyl ester

20

21400

54276-35-6

Methacrylic acid, sulphopropyl ester

21

21970

00923-02-4

N-methylolmetha- crylamide

22

22210

00098-83-9

Alpha-methylstyrene

23

25540

00528-44-9

Trimellitic acid

QM(T) = 5 mg/kg in FP

24

25550

00552-30-7

Trimellitic anhydride

QM(T) = 5 mg/kg in FP (expressed as trimellitic acid)

25

25840

03290-92-4

1,1,1-Trimethylopropane trimethacrylate

26

26230

00088-12-0

Vinylpyrrolidone

SCHEDULE 2

Regulation 16(a) and (b)

PART ILIST OF ADDITIVES TO BE ADDED TO PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS

Item

PM/REF No.

CAS No.

Name

Restrictions and specifications

19A

35160

06642-31-5

6-Amino-1, 3-dimethyluracil

SML = 5 mg/kg

19B

35170

00141-43-5

2-Aminoethanol

SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer

19C

35284

00111-41-1

N-(2-aminoethyl) ethanolamine

SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer

36E

38840

154862-43-8

Bis(-2,4-dicumylphenyl) pentaerythritoldiphosphite

SML = 5 mg/kg (as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl) pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol)

38A

39925

129228-21-3

3,3-Bis(methoxymethyl)-2,5-dimethyl hexane

SML = 0.05 mg/kg

41A

41120

10043-52-4

Calcium chloride

45A

41840

00105-60-2

Caprolactam

SML(T) = 15 mg/kg (5)

72B

47210

26427-07-6

Dibutylthiostannoic acid polymer [= thiobis(butyl-tin sulphide), polymer]

In compliance with the specifications laid down in Schedule 2B

73A

47540

27458-90-8

Di-tert-dodecyl disulfide

SML = 0.05 mg/kg

73D

48620

00123-31-9

1,4-Dihydroxybenzene

SML = 0.6 mg/kg

73E

48720

00611-99-4

4,4’-Dihydroxybenzophenone

SML(T) = 6 mg/kg (14)

77A

52645

10436-08-5

Cis-11-eicosenamide

164A

64800

00110-16-7

Maleic acid

SML(T) = 30 mg/kg (4)

167A

65920

66822-60-4

[N-methacryloyloxyethyl-N,N-dimethyl-N-carboxymethyl-ammonium chloride, sodium salt-octadecyl methacrylate-ethyl methacrylate-cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers

191A

73160

Phosphoric acid, mono-and di-n-alkyl (C16 and C18) esters

SML = 0.05 mg/kg

195B

76730

Polydimethylsiloxane, gamma-hydroxypropylated

SML = 6 mg/kg

240B

85680

01343-98-2

Silicic acid

271A

92150

01401-55-4

Tannic acids

According to the JECFA specifications

279A

93270

00108-78-1

2,4,6-Triamino-1,3, 5-triazine

SML = 30 mg/kg

281A

95270

161717-32-4

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

SML = 2 mg/kg (as sum of phosphite, phosphate and the hydrolysis product = TTBP)

PART IILIST OF ADDITIVES FOR WHICH THE ENTRY CONTAINED IN THE FIRST COLUMN (ITEM) OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED

Item

Name

36F

Bis(3-4-dimethylbenzylidene)sorbitol

38B

Bis(polyethyleneglycol)hydroxymethyl-phosphonate

73B

Diethyleneglycol

73C

1,1-Difluoroethane

73F

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

191B

Phosphoric acid, trichloroethyl ester

195C

Polyesters of 1,2-propanediol and/or 1,3-and/or polypropyleneglycol with adipic acid, also end-capped with acetic acid or fatty acids C10-C18 or n-octanol and/or n-decanol

208B

Poly (zinc glycerolate)

240C

Silicic acid, lithium, magnesium, sodium salt

281B

Vermiculite, reaction product with citric acid, lithium salt

281C

Water

281D

Waxes, refined, derived from petroleum based or synthetic hydrocarbon feed stocks

281E

White mineral oils, paraffinic, derived from petroleum based hydrocarbon feed stocks

PART IIILIST OF ADDITIVES FOR WHICH THE ENTRY CONTAINED IN COLUMN 4 (RESTRICTIONS AND SPECIFICATIONS) OF PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED

Name

Restrictions and specifications

Bis(polyethylenelycol)hydroxymethyl-phosphonate

SML = 0.6 mg/kg. Authorised until 1st January 2004

Copper iodide

SML(T) = 30 mg/kg (7) (expressed as copper) and the specific migration of this substance shall not exceed 1 mg/kg (10) (expressed as iodine)

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

SML(T) = 30 mg/kg (18)

PART IVPROVISIONS INSERTED AFTER PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS

PART II:INCOMPLETE LIST OF ADDITIVES USED IN THE MANUFACTURE OF PLASTIC MATERIALS AND ARTICLES (BEING ADDITIVES TO WHICH PARAGRAPH 5 OF PART III OF THIS SCHEDULE APPLIES)

Item

PM/REF No.

CAS No.

Name

Restrictions and specifications

1

30180

02180-18-9

Acetic acid, manganese salt

SML(T) = 0.6 mg/kg (9) (expressed as manganese)

2

31520

61167-58-6

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

SML = 6 mg/kg

3

31920

00103-23-1

Adipic acid, bis(2-ethyllhexyl) ester

SML = 18 mg/kg (1)

4

34230

Alkyl(C8-C22)sulphonic acids

SML = 6 mg/kg

5

35760

01309-64-4

Antimony trioxide

SML = 0.02 mg/kg (expressed as anti-monium and analytical tolerance included)

6

36720

17194-00-2

Barium hydroxide

SML(T) = 1 mg/kg (11) (expressed as barium)

7

36800

10022-31-8

Barium nitrate

SML(T) = 1 mg/kg (11) (expressed as barium)

8

38240

00119-61-9

Benzophenone

SML = 0.6 mg/kg

9

38560

07128-64-5

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

SML = 0.6 mg/kg

10

38700

63397-60-4

Bis(2-carbobutoxyethyl)tin-bis(isooctylmercaptoacetate)

SML = 18 mg/kg

11

38800

32687-78-8

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

SML = 15 mg/kg

12

38820

26741-53-7

Bis(2,4-di-tert-butylphenyl) pentaery-thritol diphosphite

SML = 0.6 mg/kg

13

39060

35958-30-6

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

SML = 5 mg/kg

14

39090

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

SML(T) = 1.2 mg/kg (12)

15

39120

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

SML(T) = 1.2 mg/kg (12) (expressed as N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine)

16

40000

00991-84-4

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

SML = 30 mg/kg

17

40020

110553-27-0

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

SML = 6 mg/kg

18

40160

61269-61-2

N,N’-bis(2,2,6,6-tetramethyl-4-piperidyl)hexamethylenediamine-1,2-dibromoethane, copolymer

SML = 2.4 mg/kg

19

40800

13003-12-8

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

SML = 6 mg/kg

20

40980

19664-95-0

Butyric acid, manganese salt

SML(T) = 0.6 mg/kg (9) (expressed as manganese)

21

42000

63438-80-2

(2-Carbobutoxyethyl)tin-tris (isooctylmercaptoacetate)

SML = 30 mg/kg

22

42400

10377-37-4

Carbonic acid, lithium salt

SML(T) = 0.6 mg/kg (8) (expressed as lithium)

23

42480

00584-09-8

Carbonic acid, rubidium salt

SML = 12 mg/kg

24

43600

04080-31-3

1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride

SML = 0.3 mg/kg

25

43680

00075-45-6

Chlorodifluoromethane

SML = 6 mg/kg and in compliance with the specifications laid down in Schedule 2B

26

44960

11104-61-3

Cobalt oxide

SML(T) = 0.05 mg/kg (13) (expressed as cobalt)

27

45440

Cresols, butylated, styrenated

SML = 12 mg/kg

28

46720

04130-42-1

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

QMA = 4.8 mg/6 dm2

29

47600

84030-61-5

Di-n-dodecyltin bis (isooctyl mercaptoacetate)

SML = 12 mg/kg

30

48640

00131-56-6

2,4-Dihydroxybenzophenone

SML(T) = 6 mg/kg (14)

31

48800

00097-23-4

2,2’-Dihydroxy-5,5’-dichlorodiphenylmethane

SML = 12 mg/kg

32

48880

00131-53-3

2,2’-Dihydroxy-4-methoxybenzophenone

SML(T) = 6 mg/kg (14)

33

49600

26636-01-1

Dimethyltin bis(isooctyl mercaptoacetate)

SML(T) 0.18 mg/kg (15) (expressed as tin)

34

49840

02500-88-1

Dioctadecyl disulphide

SML = 3 mg/kg

35

50160

Di-n-octylin bis(n-alkyl(C10-C16) mercapto acetate)

SML(T) = 0.04 mg/kg (16) (expressed as tin)

36

50240

10039-33-5

Di-n-octyltin bis(2-ethyllhexyl maleate)

SML(T) = 0.04 mg/kg (16) (expressed as tin)

37

50320

15571-58-1

Di-n-octyltin bis(2-ethylhexyl mercaptoacetate)

SML(T) = 0.04 mg/kg (16) (expressed as tin)

38

50360

Di-n-octyltin bis(ethyl maleate)

SML(T) = 0.04 mg/kg (16) (expressed as tin)

39

50400

33568-99-9

Di-n-octyltin bis(isooctyl maleate)

SML(T) = 0.04 mg/kg (16) (expressed as tin)

40

50480

26401-97-8

Di-n-octyltin bis(isooctyl mercaptoacetate)

SML(T) = 0.04 mg/kg (16) (expressed as tin)

41

50560

Di-n-octyltin 1,4-butanediol bis (mercaptoacetate)

SML(T) = 0.04 mg/kg (16) (expressed as tin)

42

50640

03648-18-8

Di-n-octyltin dilaurate

SML(T) = 0.04 mg/kg (16) (expressed as tin)

43

50720

15571-60-5

Di-n-octyltin dimaleate

SML(T) = 0.04 mg/kg (16) (expressed as tin)

46

50960

69226-44-4

Di-n-octyltin ethyleneglycol bis (mercaptoacetate)

SML(T) = 0.04 mg/kg (16) (expressed as tin)

47

51040

15535-79-2

Di-n-octyltin mercaptoacetate

SML(T) = 0.04 mg/kg (16) (expressed as tin)

48

51120

Di-n-octyltin thiobenzoate 2-ethyl-hexyl mercaptoacetate

SML(T) = 0.04 mg/kg (16) (expressed as tin)

49

51570

00127-63-9

Diphenyl sulphone

SML = 3 mg/kg

50

51680

00102-08-9

N,N’-diphenylthiourea

SML = 3 mg/kg

51

52000

27176-87-0

Dodecylbenzenesulphonic acid

SML = 30 mg/kg

52

52320

52047-59-3

2-(4-Dodecylphenyl)indole

SML = 0.06 mg/kg

53

52880

23676-09-7

4-Ethoxybenzoic acid, ethyl ester

SML = 3.6 mg/kg

54

53200

23949-66-8

2-Ethoxy-2’-ethyloxanilide

SML = 30 mg/kg

55

58960

00057-09-0

Hexadecyltrimethylammonium bromide

SML = 6 mg/kg

56

59120

23128-74-7

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

SML = 45 mg/kg

57

59200

35074-77-2

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

SML = 6 mg/kg

58

60320

70321-86-7

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

SML = 1.5 mg/kg

59

60400

03896-11-5

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

SML(T) = 30 mg/kg (18)

60

60800

65447-77-0

1-(2-Hydroxyethyl)-4-hydroxy-2,2,6,6-tetramethyl, piperidine-succinic acid, dimethyl ester, copolymer

SML = 30 mg/kg

61

61280

03293-97-8

2-Hydroxy-4-n-hexyloxybenzophenone

SML(T) = 6 mg/kg (14)

62

61360

00131-57-7

2-Hydroxy-4-methoxybenzophenone

SML(T) = 6 mg/kg (14)

63

61440

02440-22-4

2-(2-Hydroxy-5-methylphenyl) benzotriazole

SML(T) = 30 mg/kg (18)

64

61600

01843-05-6

2-Hydroxy-4-n-octyloxybenzophenone

SML(T) = 6 mg/kg (14)

65

63200

51877-53-3

Lactic acid, manganese salt

SML(T) = 0.6 mg/kg (9) (expressed as manganese)

66

64320

10377-51-2

Lithium iodide

SML(T) = 1 mg/kg (10) (expressed as iodium) and SML(T) = 0.6 mg/kg (8) (expressed as lithium)

67

65120

07773-01-5

Manganese chloride

SML(T) = 0.6 mg/kg (9) (expressed as manganese)

68

65200

12626-88-9

Manganese hydroxide

SML(T) = 0.6 mg/kg (9) (expressed as manganese)

69

65280

10043-84-2

Manganese hypophosphite

SML(T) = 0.6 mg/kg (9) (expressed as manganese)

70

65360

11129-60-5

Manganese oxide

SML(T) = 0.6 mg/kg (9) (expressed as manganese)

71

65440

Manganese pyrophosphite

SML(T) = 0.6 mg/kg (9) (expressed as manganese)

72

66360

85209-91-2

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

SML = 5 mg/kg

73

66400

00088-24-4

2-2’-Methylenebis(4-ethyl-6-tert-butylphenol)

SML(T) = 1.5 mg/kg (19)

74

66480

00119-47-1

2-2’-Methylenebis(4-methyl-6-tert -butylphenol)

SML(T) = 1.5 mg/kg (19)

75

67360

67649-65-4

Mono-n-dodecyltin tris(isooctyl mercaptoacetate)

SML = 24 mg/kg

76

67520

54849-38-6

Monomethyltin tris(isooctyl mercaptoacetate)

SML(T) = 0.18 mg/kg (15) (expressed as tin)

77

67600

Mono-n-octyltin tris(alkyl(C10-C16)-mercaptoacetate)

SML(T) = 1.2 mg/kg (17) (expressed as tin)

78

67680

27107-89-7

Mono-n-octyltin tris(2-ethylhexyl mercaptoacetate)

SML(T) = 1.2 mg/kg (17) (expressed as tin)

79

67760

26401-86-5

Mono-n-octyltin tris(isooctyl mercaptoacetate)

SML(T) = 1.2 mg/kg (17) (expressed as tin)

80

68078

27253-31-2

Neodecanoic acid, cobalt salt

SML(T) = 0.05 mg/kg (expressed as neodecanoic acid) and SML(T) = 0.05 mg/kg (13) (expressed as cobalt). Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC

81

68320

02082-79-3

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

SML = 6 mg/kg

82

68400

10094-45-8

Octadecylerucamide

SML = 5 mg/kg

83

69840

16260-09-6

Oleylpalmitamide

SML = 5 mg/kg

84

72160

00948-65-2

2-Phenylindole

SML = 15 mg/kg

85

72800

01241-94-7

Phosphoric acid, diphenyl 2-ethylhexyl ester

SML = 2.4 mg/kg

86

73040

13763-32-1

Phosphoric acid, lithium salts

SML(T) = 0.6 mg/kg (8) (expressed as lithium)

87

73120

10124-54-6

Phosphoric acid, manganese salt

SML(T) = 0.6 mg/kg (9) (expressed as manganese)

88

74400

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

SML = 30 mg/kg

89

77440

Polyethyleneglycol diricinoleate

SML = 42 mg/kg

90

77520

61791-12-6

Polyethyleneglycol ester of castor oil

SML = 42 mg/kg

91

78320

09004-97-1

Polyethyleneglycol monoricinoleate

SML = 42 mg/kg

92

81200

71878-19-8

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)limino]

SML = 3 mg/kg

93

81680

07681-11-0

Potassium iodide

SML(T) = 1 mg/kg (10) (expressed as iodium)

94

82020

19019-51-3

Propionic acid, cobalt salt

SML(T) = 0.05 mg/kg (13) (expressed as cobalt)

95

83595

119345-01-6

Reaction product of di-tert-butylphosphonite with biphenyl, obtained by condensation of 2, 4-di-tert-butylphenol with friedel craft reaction product of phosphorus trichloride and biphenyl

SML = 18 mg/kg and in compliance with the specifications in Schedule 2B

96

83700

00141-22-0

Ricinoleic acid

SML = 42 mg/kg

97

84800

00087-18-3

Salicylic acid, 4-tert-butylphenyl ester

SML = 12 mg/kg

98

84880

00119-36-8

Salicylic acid, methyl ester

SML = 30 mg/kg

99

85760

12068-40-5

Silicic acid, lithium aluminium salt (2:1:1)

SML(T) = 0.6 mg/kg (8) (expressed as lithium)

100

85920

12627-14-4

Silicic acid, lithium salt

SML(T) = 0.6 mg/kg (8) (expressed as lithium)

101

86800

07681-82-5

Sodium iodide

SML(T) = 1 mg/kg (10) (expressed as iodium)

102

86880

Sodium monoalkyl dialkylphenoxybenzenedi-sulphonate

SML = 9 mg/kg

103

89170

13586-84-0

Stearic acid, cobalt salt

SML(T) = 0.05 mg/kg (13) (expressed as cobalt)

104

92000

07727-43-7

Sulphuric acid, barium salt

SML(T) = 1 mg/kg (11) (expressed as barium)

105

92320

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

SML = 15 mg/kg

106

92560

38613-77-3

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

SML = 18 mg/kg

107

92800

00096-69-5

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

SML = 0.48 mg/kg

108

92880

41484-35-9

Thiodiethanol bis(3-(3-5-di-tert-butyl-4-hydroxyphenyl)propionate)

SML = 2.4 mg/kg

109

93120

00123-28-4

Thiodipropionic acid, didodecyl ester

SML(T) = 5 mg/kg (20)

110

93280

00693-36-7

Thiodipropionic acid, dioctadecyl ester

SML(T) = 5 mg/kg (20)

111

94560

00122-20-3

Triisopropanolamine

SML = 5 mg/kg

112

95280

40601-76-1

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

SML = 6 mg/kg

114

95600

01843-03-4

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

SML = 5 mg/kg

SCHEDULE 3LIST OF SUBSTANCES TO BE ADDED TO SCHEDULE 2B TO THE PRINCIPAL REGULATIONS

Regulation 17

Item

PM/REF No.

Specifications

4A

43680—

CHLORODIFLUOROMETHANE

Content of chlorofluoromethane less than 1 mg/kg of the substance

4B

47210—

DIBUTYLTHIOSTANNOIC ACID POLYMER

Molecular unit = (C8H18S3Sn2)n (n = 1,5-2)

5A

83595

REACTION PRODUCT OF DI-TERT-BUTYLPHOSPHONITE WITH BIPHENYL, OBTAINED BY CONDENSATION OF 2,4-DI-TERT- BUTYLPHENOL WITH FRIEDEL CRAFT REACTION PRODUCT OF PHOSPHORUS TRICHLORIDE AND BIPHENYL

Composition

—4,4’-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite]

(CAS No. 38613-77-3) (36—46% w/w (1))

—4,3’- Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite]

(CAS No. 118421-00-4) (17—23% w/w)

—3,3’- Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite]

(CAS No. 118421-01-5) (1—5% w/w)

—4-Biphenylene-0,0-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite]

(CAS No. 91362-37-7) (11—19% w/w)

—Tris(2,4-di-tert-butylphenyl)phosphite

(CAS No. 31570-04-4) (9—18% w/w)

—4,4’-Biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butylphenyl)phosphonite

(CAS No. 112949-970) (5% w/w)

Other specifications

—Phosphor content of minimum 5.4% to 5.9%

—Acid value of maximum 10 mg KOH per gram

—Melt range of 85—110°C

(This note is not part of the Regulations)

1

These Regulations amend, in relation to Wales, the Plastic Materials and Articles in Contact with Food Regulations 1998, so as to implement—

a

Commission Directive 2001/62/EC amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (OJ No. L221, 17.8.2001, p.18);

b

Commission Directive 2002/16/EC on the use of certain epoxy derivatives in materials intend to come into contact with foodstuffs (OJ No. L51, 22.2.2002, p.27); and

c

(in minor respects) Commission Directive 2002/17/EC amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (OJ No. L58, 28.2.2002, p.19).

2

The Regulations also reflect the revocation, with effect from 4th September 2002, of Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (OJ No. L75, 21.3.1990) as amended and its re-enactment in consolidated form by Commission Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs (OJ No. L220, 15.8.2002, p.18).

3

The Regulations amend the 1998 Regulations by—

a

adding a provision declaring that, in addition to regulating (as previously) the contact with food of certain types of plastic materials and articles, the 1998 Regulations now also include provisions which regulate the contact with food of certain other types of food contact materials, namely adhesives and materials or articles covered by surface coatings (regulation 3);

b

providing for the definition of “plastic material or article” to have an extended meaning where that term is used in the context of provisions added to the 1998 Regulations in implementation of Commission Directive 2002/16/EC (regulation 4(a)(vii) and (c));

c

extending, so as to apply to adhesives and materials and articles covered by surface coatings, the provisions in the 1998 Regulations which—

i

give to the term “sale” an extended meaning for the purposes of those Regulations,

ii

prohibit the use, sale or importation of plastic materials and articles not meeting specified standards,

iii

make available the defence of “due diligence” in the case of offences relating to plastic materials and articles,

iv

create a presumption as to the accuracy of any particulars shown in relation to a plastic material or article which may come into contact with food, and

v

apply for the purposes of those Regulations, in relation to plastic materials and articles, various provisions of the Food Safety Act 1990 (regulations 4(b), 5, 12(b), 13 and 14 respectively);

d

adding to the provisions restricting the use of certain substances as monomers or additives in the manufacture of plastic materials or articles, provisions restricting the use of 2,2-bis(4-hydroxyphenyl) propane bis(2,3-epoxypropyl) ether, (“BADGE”), bis(hydroxyphenyl) methane bis(2,3-epoxypropyl) ethers (“BFDGE”) and novolac glycidyl ethers (“NOGE”) as monomers or additives in such manufacture (regulations 6(a) and 8(a));

e

changing (from 31st December 2001 to 31st December 2004) the date beyond which the monomers listed in Section B of Schedule 1 to the 1998 Regulations may no longer be used in the manufacture of plastic materials or articles and modifying the list of the types of plastic materials and articles to which the restrictions on the use of monomers in their manufacture do not apply (regulation 6(b) and (c));

f

introducing new restrictions on the manufacture of plastic materials and articles using BADGE, BFDGE or NOGE other than as monomers or additives (regulation 7);

g

amending the provisions governing the testing of the capability of plastic materials and articles to transfer their constituents to food, in particular by adding provisions governing the testing of that capability in the case of BADGE, BFDGE and NOGE (regulations 9 and 18);

h

adding a provision restricting the extent to which certain plastic materials or articles are allowed to transfer certain substances to food (regulation 10);

i

introducing new restrictions on the manufacture of adhesives or materials and articles covered by surface coatings using BADGE, BFDGE or NOGE and new provisions governing the testing of the capability of such adhesives, materials or articles to transfer those substances to food (regulation 11);

j

making it an offence to contravene any of the restrictions referred to in sub-paragraphs (d), (f) or (i) above and including transitional provisions (regulation 12 (a) and (c));

k

adding new substances to the list of monomers which may be used in the manufacture of plastic materials or articles and amending the conditions of use of certain monomers used in such manufacture (regulation 15);

l

adding new substances to the non-exhaustive list of additives used in the manufacture of plastic materials or articles, amending the conditions of use of certain additives used in such manufacture and deleting one additive from that list (regulations 8(a) and 16);

m

adding certain substances to the list of substances whose specifications are set out in Schedule 2B to the 1998 Regulations (regulation 17); and

n

making a consequential amendment to the Food Safety (Sampling and Qualifications) Regulations 1990 (regulation 19).

4

A regulatory appraisal, which includes a compliance cost assessment of the effect that they are likely to have on business costs, has been prepared for these Regulations.