2002 No. 498

FOOD

The Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2002
Made
7th November 2002
Laid before the Scottish Parliament
8th November 2002
Coming into force
30th November 2002
The Scottish Ministers, in exercise of the powers conferred by sections 6(4), 16(2), 17(1), 26(1)(a) and (3), 31 and 48(1) of the Food Safety Act 1990 and of all other powers enabling them in that behalf, having had regard, in accordance with section 48(4A) of that Act, to relevant advice given by the Food Standards Agency, and after consultation in accordance with section 48(4) and (4B) of that Act, hereby make the following Regulations:

Citation, commencement and extent
1
1
These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2002 and shall come into force on 30th November 2002.
2
These Regulations shall extend to Scotland only.

Amendments to the Plastic Materials and Articles in Contact with Food Regulations 1998
2
The Plastic Materials and Articles in Contact with Food Regulations 1998 (“the principal Regulations”) shall be amended in accordance with regulations 3 to 18.
3
After regulation 1 (title, commencement and extent) there shall be inserted–

Scope of these Regulations
1A
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
regulations 8A and 8B apply only to adhesives and to materials or articles covered by surface coatings.
.
4
In regulation 2 (interpretation)–
a
in paragraph (1)–
i
after the definition of “additive” there shall be inserted–
- “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–
- “capable” means capable as established–
  1. in relation to any plastic material or article, under regulation 6; and
  2. in relation to any adhesive or material or article covered by a surface coating, under regulation 8B;
;
iii
after the definition of “capable” there shall be inserted–
- “Commission Directive 2002/16” means Commission Directive 2002/16 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs ;
;
iv
for the definition of “the Directive”, there shall be substituted–
- “the Directive” means Commission Directive 2002/72 relating to plastic materials and articles intended to come into contact with foodstuffs ;
;
v
after the definition of “import” there shall be inserted–
- “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
after the definition of “monomer” there shall be inserted–
- “NOGE” means novolac glycidyl ethers not covered by Article 1(a) or (b) of Commission Directive 2002/16;
; and
vii
at the end of the definition of “plastic material or article” there shall be inserted “, except that, in the 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 a material or article made of any type of plastic”;
b
for paragraph (2), there shall be substituted–
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
after paragraph (4) there shall be inserted–
5
The provisions referred to in the definition of “plastic material or article” in paragraph (1) above are regulations 3, 4, 4A, 5, 6, 10, 11 and 12 and Schedules 3 and 4.
.
5
In regulation 3 (restriction on the use, sale or importation of plastic materials and articles)–
a
in paragraphs (1) and (2), after the words “plastic material or article”, wherever they appear, there shall be inserted “, adhesive or material or article covered by a surface coating”;
b
at the end of paragraph (4)(a)(i)(cc) the word “or” shall be deleted;
c
for sub-paragraph (4)(a)(i)(dd) there shall be substituted–
dd
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
;
d
after sub-paragraph (4)(a)(i)(dd) there shall be inserted–
ee
it has been manufactured in contravention of a prohibition contained in regulation 4A(1), (2) or (3); and
; and
e
there shall be inserted at the end–
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 paragraph (1) there shall be substituted–
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 in the corresponding entry in column 4 of that relevant 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 they are 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
for paragraphs (2)(b) and (c) there shall be substituted–
b
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
c
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–
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 “Paragraph (1)” there shall be substituted “Paragraph (1)(a)”;
e
after paragraph (5) there shall be inserted–
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 “paragraph (1)” there shall be substituted “paragraph (1)(a)”; and
ii
after “Part I of Schedule 1” there shall be inserted “or to which paragraph (1)(b) or (1)(c) above relates”.
7
After regulation 4 (restriction on manufacture with monomers) there shall be inserted–

Restriction on the manufacture of plastic materials and articles using certain substances other than as monomers or additives
4A
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 I 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 Annex I to that Directive.
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 Annex II to that Directive.
6
On or 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 paragraph (1) there shall be substituted–
1
Subject to the following paragraphs of this regulation, no person shall use in the manufacture of any 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 Schedule 2, 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 of Schedule 2, 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 Annex I to that Directive;
c
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 Annex II to that Directive; or
d
NOGE to the extent that they are 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), after “Part I” there shall be inserted “or Part II”;
c
for paragraph (3), there shall be substituted–
3
Part III of Schedule 2 shall have effect to supplement this regulation and Parts I and II of Schedule 2.
;
d
in paragraph (4)–
i
after “Schedule 2” there shall be inserted “, or column 4 of Part II of Schedule 2,”; and
ii
in each of sub-paragraphs (a) and (b), for “therein” there shall be substituted “in column 4 of Part I or Part II of Schedule 2, as appropriate,”;
e
after paragraph (4) there shall be inserted–
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 or after 1st March 2003, no plastic material or article manufactured using NOGE as an additive shall fail to comply with the requirements of the first sentence of Article 4 of Commission Directive 2002/16.
; and
f
in paragraph (5), after “Schedule 2” there shall be inserted “, or column 4 of Part II of Schedule 2,”.
9
In regulation 6 (method of testing capability of transferring constituents)–
a
for paragraph (1) there shall be substituted–
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 the Directive (which may be applied on compliance with the conditions stated therein) by the verification methods specified in Schedules 3 and 4;
b
in any case where the extent to which vinyl chloride, as identified in Section A of Part I of Schedule 1, is capable of such transfer falls to be established, by the method referred to in regulation 14(2) of the 1987 Regulations.
; and
b
after paragraph (3) there shall be inserted–
4
The specific migration of a constituent from a plastic material or article shall, where applicable, be determined in the manner specified in the relevant sub-division of paragraph 8 of Annex II 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 and third sentences 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 paragraph 8 of that Annex relating to the term “QMA”.
.
10
For regulation 7A (specifications) there shall be substituted–

Specifications
7A
1
Subject to paragraph (3), no plastic material or article manufactured using isocyanates or colourants prepared by diazo–coupling shall be capable of transferring in a detectable quantity primary aromatic amines (expressed as aniline), not being primary aromatic amines listed in these Regulations, to food with which the 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 relevant Part or, as the case may be, Schedule concerned.
3
For the purposes of paragraph (1), “detectable quantity” means a quantity of at least DL0.02 milligrams per kilogram of food or food simulant (analytical tolerance included).
.
11
After regulation 8 (labelling) there shall be inserted–

Restriction on manufacture with certain substances of adhesives and materials and articles covered by surface coatings
8A
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 I 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 I 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 or 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 adhesives and of materials or articles covered by surface coatings to transfer constituents and methods of analysis
8B
1
Subject to paragraphs (2) and (3) below, 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 the adhesive or, as the case may be, material or article may come into contact to the extent that such capability is established for those purposes by the verification methods specified in Section A of Schedule 3 and in Schedule 4.
2
Subject to paragraph (3) below, 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) above, Schedules 3 and 4 shall have effect as if–
a
the references in Section A of Schedule 3 and in Schedule 4 to “plastic material or article” were references to “adhesive or a material or article covered by a surface coating”;
b
the references in paragraph 4(3) and (4) of Section A of Schedule 3 to “a migration limit specified in regulation 7, Schedule 1 or Schedule 2” were references to “a migration limit specified in regulation 8A(4) or (5)”; and
c
the references 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 references to “regulation 8A(4) or (5)”.
4
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 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 sentence and third sentences of that Article.
.
12
In regulation 10 (offences)–
a
in paragraph (1), for “regulation 3, 4(1), 5(1) or 8” there shall be substituted “regulation 3, 4(1), 4A(1), (2) or (3), 5(1), 8(1) or 8A(1), (2) or (3)”;
b
in each of paragraphs (9) and (10), after “plastic material or article” there shall be inserted “or, as the case may be, adhesive or material or article covered by a surface coating,”; and
c
after paragraph (15) there shall be inserted–
16
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 intended to come into contact with food which was put into free circulation in the European Community on or 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
For the purposes of paragraph (16) above, “free circulation” shall have the same meaning as it bears in Article 23.2 of the Treaty establishing the European Community.
18
The provisions referred to in paragraph (16) above are regulations 5(c), 6(b), 8(a), (b) and (d), 10, 12(a), 15, 16 and 17 of the Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2002 to the extent that they implement or provide for the enforcement of those requirements of Commission Directive 2001/62/EC amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs to which Article 2 of that Directive applies.
19
In any proceedings for an offence under these Regulations, it shall be a defence to prove that–
a
the act constituting the offence was the sale of–
i
an adhesive; or
ii
a material or article covered by a surface coating,
which was brought into contact with food on or before 28th February 2003, provided that the date of filling appeared on the materials and articles at the time of sale and that the labelling or marking of which complied at the time of sale with the requirements of Directive 2000/13 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 ; and
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 (19) above are regulations 5(a) and (e), 11 and 12(a) of the Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2002 which implement or provide for the enforcement of those requirements of Commission Directive 2002/16 which relate to adhesives or materials and articles covered by surface coatings.
.
13
In regulation 11 (presumption as to food with which a plastic material or article is to come into contact) after the words “plastic material or article”, wherever they appear, there shall be inserted “, adhesive or material or article covered by a surface coating,”.
14
In regulation 12 (application of other provisions)–
a
in paragraph (1) after “plastic materials or articles” there shall be inserted “, adhesives and materials or articles covered by a surface coating”; and
b
in paragraph (3) for “relate to plastic materials or articles” there shall be substituted “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 listed in the third 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 of Section A of Part I of Schedule 1 to the principal Regulations (item) there shall be substituted the item number and letter for it specified in the second column (new item) of Part II of Schedule 1 to these Regulations; and
iii
in the case of each monomer listed 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 of Section A of Part I of Schedule 1 to the principal Regulations (restrictions and specifications) there shall be substituted the entry for it specified in the second column (restrictions and specifications) of Part III of Schedule 1 to these Regulations;
b
for Section B of Part I there shall be substituted Part IV of Schedule 1 to these Regulations; and
c
in Part II, for paragraph 4 there shall be substituted–
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 listed in the third column of Part II of Schedule 2 to these Regulations, for the item number and letter for that additive specified opposite to it in the first column in Part I of Schedule 2 to the principal Regulations (item) there shall be substituted the item number and letter for it specified in the second column (new item) of Part II of Schedule 2 to these Regulations;
iv
in the case of each additive listed 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 in Part I of Schedule 2 to the principal Regulations (restrictions and specifications) there shall be substituted the entry for it specified in the second column (restrictions and specifications) of Part III of Schedule 2 to these Regulations; and
v
all the entries for the additive Silicic acid, salts, (item 241) shall be omitted;
b
after Part I there shall be inserted 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 “Part II” there shall be substituted “Part III”;
ii
in paragraph 1, for “Part I” there shall be substituted “Parts I and II”;
iii
in each of paragraphs 2, 3 and 4, after “Part I” there shall be inserted “or Part II”;
iv
for paragraph 4 there shall be substituted–
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
after paragraph 4 there shall be inserted–
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 with 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/EEC and Council Directive 85/572/EEC .
.
17
In Schedule 2B (specifications)–
a
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; and
b
at the end there shall be inserted–
Notes:– Where an entry in column 2 of this Schedule (specification) 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 this Schedule:–
(1) Quantity of substance/quantity of formulation.
.
18
In Schedule 3 (provisions applicable when testing compliance with the migration limits)–
a
in paragraph 4(3) and (4) of section A, after “specified in regulation” there shall be inserted “4(5A), 4A(4) or (5), 5(4A) or (4B) or”; and
b
for sub-paragraph (2)(b) of paragraph 8 of section B there shall be substituted–
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.
.
MARY MULLIGAN
Authorised to sign by the Scottish Ministers
St Andrew’s House,
Edinburgh
7th November 2002
SCHEDULE 1
Regulation 15(a) and (b)
PART I

LIST 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 = 0.02 mg/6 dm2
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-Naphthalenedicarboxylic 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 ether | QMA = 0.005 mg/6 dm2. 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.
214A | 25380 | | Trialkyl acetic acid (C7-C17), vinyl esters (= vinyl versatate) | QMA = 0.05 mg/6 dm2
215A | 25450 | 26896-48-0 | Tricyclodecanedimethanol | SML = 0.05 mg/kg
217A | 25900 | 00110-88-3 | Trioxane | SML = 0.05 mg/kg
PART II

LIST 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
Previous Item | New Item | Name
52A | 52B | 4-tert-Butylphenol
88B | 88C | 1.3 Dioxolane
121B | 121C | Isophthalic acid
135A | 135C | Methacrylic acid, 2-(dimethylamino) ethyl ester
145A | 145B | 3-Methyl-1-butene
159A | 159B | Perfluoropropyl perfluorovinyl ether
214A | 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) | Use must be before 1st January 2005 and prior to that date be as specified in paragraph 1 of Annex I to Commission Directive 2002/16 as read with the second sentence of paragraph 2 of that Annex
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)
IV

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

MONOMERS AUTHORISED UP TO THE 31st DECEMBER 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-methylolmethacrylamide |
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 I

LIST 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
208A | 81220 | 192268-64-7 | Poly-[[6-[N-(2,2,6,6-tetramethyl-4-piperidinyl)-n-butylamino)-1,3,5-triazine-2,4-diyl][(2,2,6,6-tetramethyl-4-piperidinyl)imino]-1,6-hexanediyl-[(2,2,6,6-tetramethyl-4-piperidinyl)imino]]-alpha-[N,N,N',N'-tetrabutyl-N"-(2,2,6,6-tetramethyl-4-piperidinyl)-N"-[6,(2,2,6,6-tetramethyl(-4-piperidinylamino)-hexyl][1,3,5-triazine-2,4,6-triamine]-omega-N,N,N',N'-tetrabutyl-1,3,5-triazine-2,4-diamine] | SML = 5 mg/kg
229A | 83599 | 68442-12-6 | Reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltin | SML(T) = 0.18 mg/kg (15) (expressed as tin)
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 II

LIST OF ADDITIVES FOR WHICH THE ENTRY CONTAINED IN THE FIRST COLUMN (ITEM) OF PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED
Previous Item | New Item | Name
36E | 36F | Bis(3-4-dimethylbenzylidene)sorbitol
38A | 38B | Bis(polyethyleneglycol)hydroxymethyl-phosphonate
73A | 73B | Diethyleneglycol
73B | 73C | 1,1-Difluoroethane
73C | 73F | 2,4-Dimethyl-6-(1-methylpentadecyl)phenol
191A | 191B | Phosphoric acid, trichloroethyl ester
195B | 195C | 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 C10-C18 or n-octanol and or n-decanol
208A | 208B | Poly (zinc glycerolate)
240B | 240C | Silicic acid, lithium, magnesium, sodium salt
281A | 281B | Vermiculite, reaction product with citric acid, lithium salt
281B | 281C | Water
281C | 281D | Waxes, refined, derived from petroleum based or synthetic hydrocarbon feed stocks
281D | 281E | White mineral oils, paraffinic, derived from petroleum based hydrocarbon feed stocks
PART III

LIST 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
Benzaldehyde | In compliance with regulation 4(2) of the 1987 Regulations
Bis(polyethylenelycol) hydroxymethyl-phosphonate | SML = 0.6 mg/kg. Authorised until 1st January 2004.
Camphor | In compliance with the regulation 4(2) of the 1987 Regulations.
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 IV

PROVISIONS 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 antimonium 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)
44 | 50800 | – | Di-n-octyltin dimaleate, esterified | SML(T) = 0.04 mg/kg (16) (expressed as tin)
45 | 50880 | –s | Di-n-octyltin dimaleate, polymers (n = 2-4) | 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)imino] | 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 dialkylphenoxybenzenedisulphonate | 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
113 | 95360 | 27676-62-6 | 1,3,5-Tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione | SML = 5 mg/kg
114 | 95600 | 01843-03-4 | 1,1,3-Tris(2-methyl-4-hydroxy-5-tert-butylphenyl)butane | SML = 5 mg/kg
SCHEDULE 3

LIST 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. 112949-97-0) (<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)
These Regulations, which extend to Scotland only, amend for the second time the Plastic Materials and Articles in Contact with Food Regulations 1998 (S.I. 1998/1376, “the 1998 Regulations”). The Regulations 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 (O.J. No. L 221, 17.8.2001, p.18);
b
Commission Directive 2002/16/EC on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs (O.J. No. L 51, 22.2.2002, p.27); and
c
(in relation to camphor and benzaldehyde only) Commission Directive 2002/17/EC amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (O.J. No. L 58, 28.2.2002, p.19).
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 (O.J. No. L 75, 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 (O.J. No. L 220 15.8.2002, p.18).
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).
A Regulatory Impact Assessment, which includes a compliance cost assessment of the effect which these Regulations are likely to have on business costs, has been prepared and has been placed in the Scottish Parliament Information Centre. Copies may be obtained from the Food Standards Agency, 6th Floor, St Magnus House, 25 Guild Street, Aberdeen AB11 6NJ.
1990 c. 16; section 6(4) was amended by paragraph 6 of Schedule 9 to the Deregulation and Contracting Out Act 1994 (c. 40) and by paragraph 10(3) of Schedule 5 to the Food Standards Act 1999 (c. 28) (“the 1999 Act”). Sections 16(2) and 48(1) were amended by paragraph 8 of Schedule 5 to the 1999 Act; section 17(1) was amended by paragraphs 8 and 12 of Schedule 5 to the 1999 Act; section 26(3) was amended by Schedule 6 to the 1999 Act; amendments made by Schedule 5 to the 1999 Act which extend to Scotland shall be taken as pre-commencement enactments for the purposes of the Scotland Act 1998 (c. 46) by virtue of section 40(2) of the 1999 Act. The functions of the Secretary of State were transferred to the Scottish Ministers by virtue of section 53 of the Scotland Act 1998.
Section 48(4A) was inserted by paragraph 21 of Schedule 5 to the Food Standards Act 1999.
Section 48(4B) was inserted by paragraph 21 of Schedule 5 to the Food Standards Act 1999.
S.I. 1998/1376, amended by S.S.I. 2000/431.
O.J. No. L 51, 22.2.02, p.27.
O.J. No. L 220, 15.8.02, p.18.
O.J. No. L 221, 17.8.01, p.18.
O.J. No. L 109, 6.5.00, p.29.
O.J. No. L 297, 23.10.82, p.26, last amended by Commission Directive 97/48/EC (O.J. No. L 222, 12.8.97, p.10).
O.J. No. L 372, 31.12.85, p.14.