The Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2002
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.
3.
“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)
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)
““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)
““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)
““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 foodstuffs5;”;
(iv)
““the Directive” means Commission Directive 2002/72 relating to plastic materials and articles intended to come into contact with foodstuffs6;”;
(v)
““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)
““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)
“(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)
“(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)
“(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)
“(ee)
it has been manufactured in contravention of a prohibition contained in regulation 4A(1), (2) or (3); and”; and
(e)
“(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)
“(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)
“(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)
“(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)
“(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.
“Restriction on the 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 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)
“(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)
“(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)
“(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)
“(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)
“(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.
“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 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.
“Restriction on manufacture with certain substances of adhesives and materials and articles covered by surface coatings8A.
(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 analysis8B.
(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)
“(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 foodstuffs7 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 foodstuffs8; 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)
“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)
“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)
“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/EEC9 and Council Directive 85/572/EEC10.”.
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)
“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:–
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)
“(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.”.
St Andrew’s House,
Edinburgh
SCHEDULE 1
PART ILIST OF MONOMERS TO BE ADDED TO SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS
“Item
PM/REF No.
CASNo.
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 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
“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 IIILIST 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)”
IVPROVISIONS 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.
CASNo.
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
PART ILIST OF ADDITIVES TO BE ADDED TO PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS
“Item
PM/REF No.
CASNo.
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 IILIST 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 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
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 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.
CASNo.
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 3LIST OF SUBSTANCES TO BE ADDED TO SCHEDULE 2B TO THE PRINCIPAL REGULATIONS
“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”
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–
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);
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
(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–
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);
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));
extending, so as to apply to adhesives and materials and articles covered by surface coatings, the provisions in the 1998 Regulations which–
give to the term “sale” an extended meaning for the purposes of those Regulations;
prohibit the use, sale or importation of plastic materials and articles not meeting specified standards;
make available the defence of “due diligence” in the case of offences relating to plastic materials and articles;
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
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);
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));
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));
introducing new restrictions on the manufacture of plastic materials and articles using BADGE, BFDGE or NOGE other than as monomers or additives (regulation 7);
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);
adding a provision restricting the extent to which certain plastic materials or articles are allowed to transfer certain substances to food (regulation 10);
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);
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));
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);
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);
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.