Materials in Contact with Foodstuffs (Amendment) Regulations,

L.N. 176 of 2008

FOOD SAFETY ACT

(CAP. 449)

Materials in Contact with Foodstuffs (Amendment) Regulations,

IN exercise of the powers conferred by article 10 of the Food Safety

Act, the Minister for Social Policy has made the following regulations>–

(1) The title of these regulations is the Materials in Contact

with Foodstuffs (Amendment) Regulations, 2008, and they shall be read

and construed as one with the Materials in Contact with Foodstuffs

Regulations, 2003 hereinafter referred to as “the principal regulations”.

(2) These regulations shall enter into force on the 1 st May,

2008.

(1) Regulation 3 implements the provisions of Commission

Directive 2007#19#EC of 2 April 2007 amending Directive 2002#72#EC

relating to plastic materials and articles intended to come into contact

with food and Council Directive 85#572#EEC laying down the list of

simulants to be used for testing migration of constituents of plastic

materials and articles intended to come into contact with foodstuffs.

(2) The trade in and use of plastic materials and articles

intended to come into contact with food and complying with Directive

2002#72#EC, as amended by Directive 2007#19#EC, shall be permitted

as from 1 May 2008.

(3) The manufacture and importation into the Community

of lids containing a gasket which do not comply with restrictions and

specifications for Ref. No 30340< 30401< 36640< 56800< 76815< 76866<

88640 and 93760 laid down in Directive 2002#72# EC as amended by

Directive 2007#19#EC, shall be prohibited as from 1 July 2008.

(4) The manufacture and importation into the Community

of plastic materials and articles intended to come into contact with food

which do not comply with restrictions and specifications for phthalates

Ref. No 74560< 74640< 74880< 75100< 75105 laid down in Directive

2002#72#EC as amended by Directive 2007#19#EC shall be prohibited

as from 1 July 2008.

(5) Without prejudice to regulations 2(3) and 2(4), the

manufacture and importation into the Community of plastic materials

(5)

Without prejudice to regulations 2(3) and 2(4), the manufacture and

importation into the Community of plastic materials and articles intended to

come into contact with food which do not comply with Directive 2002/72/EC

as amended by Directive 2007/19/EC, shall be prohibited as from 1 May 2009.

For the Fifth Schedule to the principal regulations, there shall be substituted

Amends the Fifth

the following:-

Schedule to the

principal

regulations.

“FIFTH SCHEDULE

Plastics

1. This Schedule contains specific provisions within the meaning of regulation 4.

2. This Schedule shall apply to the following materials and articles which, in the

finished product state, are intended to come into contact or are brought into

contact with foodstuffs and are intended for that purpose (hereafter referred to

as ‘plastic materials and articles’)

(a)

materials and articles and parts thereof consisting exclusively

of plastics;

(b)

plastic multi-layer materials and articles;

(c)

plastic layers or plastic coatings, forming gaskets in lids

that together are composed of two or more layers of different

types of materials.

3. For the purposes of this Schedule, ‘plastics’ means the organic

macromolecular compounds obtained by polymerization, polycondensation,

polyaddition or any other similar process from molecules with a lower

molecular weight or by chemical alteration of natural macromolecules. Other

substances or matter may be added to such macromolecular compounds.

However, the following shall not be regarded as ‘plastics’

(a)

Varnished or unvarnished regenerated cellulose film, covered

by the Fourth Schedule;

(b)

Elastomers and natural and synthetic rubber;

(c)

Paper and paperboard, whether modified or not or by the

addition of plastics;

(d)

Surface coatings obtained from

(i) Paraffin waxes, including synthetic paraffin waxes,

and/or microcrystalline waxes,

(ii) Mixtures of the waxes listed in the first indent with each

other and/or with plastics;

(e)

Ion-exchange resins;

(f)

Silicones.

Without prejudice to paragraph 2(c), this Schedule shall not apply to materials

and articles composed of two or more layers, one or more of which does not

consist exclusively of plastics, even if the one intended to come into direct

contact with foodstuffs does consist exclusively of plastics.

For the purposes of this Schedule the following definitions shall apply

(a)

“plastic multi-layer material or article” means a plastic material

or article composed of two or more layers of materials, each

consisting exclusively of plastics, which are bound together by

means of adhesives or by other means;

(b)

“plastic functional barrier” means a barrier consisting of one or

more layers of plastics which ensures that the finished material

or article complies with Article 3 of Regulation (EC) No

1935/2004 of the European Parliament and of the Council ( 1 )

and with this Schedule;

(c)

“non-fatty foods” means foods for which in migration testing

simulants other than simulant D are laid down in the Seventh

Schedule.

Plastic materials and articles shall not transfer their constituents to foodstuffs

in quantities exceeding 60 milligrams of the constituents released per kilogram

of foodstuff or food stimulant (mg/kg) (overall migration limit).

However, this limit shall be 10 milligrams per square decimetre of surface

area of material or article (mg/dm 2 ) in the case of the following

(a)

articles which are containers or are comparable to containers or

which can be filled, with a capacity of less than 500 millilitres

(ml) or more than 10 litres (l);

(b)

sheet, film or other material or articles which cannot be filled or

for which it is impracticable to estimate the relationship

between the surface area of such material or article and the

quantity of food in contact therewith.

For plastic materials and articles intended to be brought into contact

with or already in contact with food intended for infants and young

children, as defined in the Infant Formulae and Follow-On Formulae

Regulations, 2007 and the Processed Cereal-Based Foods and Other

L.N. 304 of 2007

Foods for Infants and Young Children Regulations, 2007, the overall

L.N. 227 of 2007

migration limit shall always be 60 mg/kg.

Only those monomers and other starting substances listed in the Part II of this

Schedule, Section A may be used for the manufacture of plastic materials and

articles subject to the restrictions set out therein.

The lists appearing in the Part II of this Schedule, Sections A and B,

do not yet include monomers and other starting substances used only in the

manufacture of

(a)

surface coatings obtained from resinous or polymerized

products in liquid, powder or dispersion form, such as

varnishes, lacquers, paints, etc.,

(b)

epoxy resins,

(c)

adhesives and adhesion promoters,

(d)

printing inks.

A list of additives which may be used for the manufacture of plastic materials

and articles, together with the restriction and/or specifications on their use, is

set out in the Part III of this Schedule.

For the additives listed in Part III of this Schedule, Section B, the verification

of compliance with the specific migration limits in simulant D or in the test

media of substitute tests as laid down in paragraph 6 of the Sixth Schedule

and paragraph 2 of the Seventh Schedule shall apply from the 1 st May,

2008.

The lists in the Part III of this Schedule, Sections A and B do not yet

include the following additives

(a)

Additives used only in the manufacture of

(i)

Surface coatings obtained resinous or polymerised

products in liquid, powder or dispersion form, such as

varnishes, lacquers, paints,

(ii)

Epoxy resins,

(iii)

Adhesives and adhesion promoters,

(iv)

Printing inks;

(b)

Colorants;

(c)

Solvents.

Any person interested in the inclusion in the list referred to in paragraph 10

of an additive, which is already placed on the market in one or more of the

Member States, shall submit data evaluation of its safety by the European

Food Safety Authority by the 31 st December, 2006 at the latest. For the

submission of the required data, the applicant shall consult the “Guidelines of

the European Food Safety Authority for the presentation of an application for

safety assessment of a substance to be used in food contact materials

prior to its authorisation”.

If during the examination of the data referred to in paragraph 13, the

European Food Safety Authority calls for supplementary information, the

additive may continue to be subject to national law until the Authority has

issued an opinion, provided that the information is submitted within the time

limits specified by the Authority.

For the use of additives for the manufacture of plastic layers or plastic

coatings in lids referred to in paragraph 2(c), listed in Part III of this Schedule,

the restrictions and/or specifications on their use set out in that Part of this

Schedule shall apply, without prejudice to paragraph 11;

For the use of additives exclusively acting as polymerization production aids

which are not intended to remain in the finished article (hereinafter PPAs), for

the manufacture of plastic materials and articles, listed in Part III of this

Schedule, the restrictions and/or specifications on their use set out in that Part

of this Schedule shall apply, without prejudice to paragraph 11;

The use of azodicarbonamide, Ref. No 36640 (CAS No 000123-77-3) in the

manufacture of plastic materials and articles is prohibited.

Only the products obtained by means of bacterial fermentation listed in the

Part IV of this Schedule may be used in contact with foodstuffs.

Additives referred to in paragraph 10, which are authorised as food additives

by Council Directive 89/107/EEC or flavourings by Council Directive

88/388/EEC shall not migrate into

(a)

Foodstuffs in quantities having a technological function in the final

foodstuffs;

(b)

Foodstuffs for which their use is authorised as food additives or

flavourings, in quantities exceeding the restrictions provided for in

Directive 89/107/EEC or in Directive 88/388/EEC or in paragraph 10

of this Schedule, whichever is the lower;

(c)

Foodstuffs for which their use is not authorised as food additives or

flavourings, in quantities exceeding the restrictions set out in

paragraph 10 of this Schedule.

At the marketing stages other than the retail stages, plastic materials and

articles which are intended to be placed in contact with foodstuffs and which

contain additives referred to in paragraph 19 shall be accompanied by a

written declaration containing the information referred to in paragraph 37.

By way of derogation from paragraph 19, when the substances referred to in

point (a) of paragraph 19 are used as active components of active food contact

materials and articles, they may be subject to national provisions.

General specifications related to plastic materials and articles are laid down in

the Part V of this Schedule, Part A. Other specifications related to some

substances appearing in Parts II, III and IV of this Schedule are laid down

in Part V of this Schedule, Part B.

The meaning of the numbers between brackets appearing in the column

‘Restrictions and/or specifications’ is explained in Part VI of this Schedule.

The specific migration limits in the list set out in Parts II and III of this

Schedule are expressed in mg/kg. However, such limits are expressed in

mg/dm 2 in the following cases

(a)

Articles which are containers or are comparable to containers

or which can be filled, with a capacity less than 500 ml or more

than 10 litres;

(b)

Sheet, film or other material or articles which cannot be filled

or for which it is impracticable to estimate the relationship

between the surface area of such material or article and the

quantity of food in contact therewith.

In those cases, the limits set out in the Parts II and III of this Schedule,

expressed in mg/kg shall be divided by the conventional conversion

factor of 6 in order to express them in mg/dm 2 .

For plastic materials and articles

intended to be brought into contact with or already in contact with

food for infants and young children as defined in the Infant

Formulae and Follow-On Formulae Regulations, 2007 and the

Processed Cereal-Based Foods and Other Foods for Infants and

Young Children Regulations, 2007, the SMLs shall always be

applied as mg/kg.

In a plastic multi-layer material or article, the composition of each plastic

layer shall comply with this Schedule.

By way of derogation from paragraph 26, a layer which is not in direct

contact with food and is separated from the food by a plastic functional

barrier, may, provided that the finished material or article complies with the

specific and overall migration limits specified in this Schedule

(a)

not comply with the restrictions and specifications set in this

Schedule,

(b)

be manufactured with substances other than those included in

this Schedule or in the national lists concerning the plastic

materials and articles intended to come into contact with food.

The migration of the substances referred to in paragraph 27(b) into food or

simulant shall not exceed 0,01 mg/kg, measured with statistical certainty by a

method of analysis in accordance with Article 11 of Regulation (EC) No

882/2004 of the European Parliament and of the Council ( 2 ). This limit shall

always be expressed as concentration in foods or simulants. It shall apply to

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

a group of compounds, if they are structurally and toxicologically related, in

particular isomers or compounds with the same relevant functional group, and

shall include possible set-off transfer.

The substances referred to in paragraph 27(b) shall not belong to either of the

following categories

(a)

substances classified as proved or suspect “carcinogenic”,

“mutagenic” or “toxic to reproduction” substances in Annex I

to Council Directive 67/548/EEC ( 3 );

(b)

substances classified under the self-responsibility criteria as

‘carcinogenic’, ‘mutagenic’ or ‘toxic to reproduction’

according to the rules of Annex VI to Directive 67/548/EEC.

Verification of compliance with the migration limits shall be carried out in

accordance with the rules laid down in the Sixth and Seventh Schedules to

these regulations and the further provisions set out in Part I of this Schedule.

The verification of compliance with the specific migration limits

provided for in paragraph 30 shall not be compulsory, if the value of overall

migration determination implies that the specific migration limits referred to in

that paragraph are not exceeded.

The verification of compliance with the specific migration limits provided for

in paragraph 30 shall not be compulsory, if it can be established that, by

assuming complete migration of the residual substance in the material or

article, it cannot exceed the specific limit of migration.

The verification of compliance with the specific migration limits provided for

in paragraph 30 may be ensured by the determination of the quantity of a

substance in the finished material or article provided that a relationship

between that quantity and the value of the specific migration of the substance

has been established either by an adequate experimentation or by the

application of generally recognised diffusion models based on scientific

evidence. To demonstrate the non-compliance of a material or article,

confirmation of the estimated migration value by experimental testing is

obligatory.

Notwithstanding paragraph 30, for phthalates (Ref. No 74640, 74880, 74560,

75100, 75105) referred to in the Part III of this Schedule, Part B, the

verification of the SML shall only be performed in food simulants. However,

verification of the SML may be performed in food where the food has not

already been in contact with the material or article and is pre-tested for the

phthalate and the level is not statistically significant or greater than or equal to

the limit of quantification.

OJ 196, 16.8.1967, p. 1.

At the marketing stages other than the retail stage, plastic materials and

articles as well as the substances intended for the manufacturing of those

materials and articles, shall be accompanied by a written declaration in

accordance with Article 16 of Regulation (EC) No 1935/2004.

The declaration referred to in paragraph 35 shall be issued by the business

operator and shall contain the information laid down in Part VIa of this

Schedule.

Appropriate documentation to demonstrate that the materials and articles as

well as the substances intended for the manufacturing of those materials and

articles comply with the requirements of this Schedule shall be made available

by the business operator to the national competent authorities on request. That

documentation shall contain the conditions and results of testing, calculations,

other analysis, and evidence on the safety or reasoning demonstrating

compliance.

PART I

FURTHER PROVISIONS APPLICABLE WHEN CHECKING COMPLIANCE WITH

THE MIGRATION LIMITS

General provisions

1. When comparing the results of the migration tests specified in the Sixth

Schedule, the specific gravity of all the simulants should conventionally be

assumed to 1. Milligrams of substance(s) released per litre of stimulant (mg/l)

will thus correspond numerically to milligrams of substance(s) released per

kilogram of simulant and, taking into account the provisions laid down in the

Seventh Schedule, to milligrams of substance(s) released per kilogram of

foodstuff.

2. Where the migration tests are carried out on samples taken from the material

or article or on samples manufactured for the purpose, and the quantities of

foodstuff or simulant placed in contact with the sample differ from those

employed in the actual conditions under which the material or article is used,

the results obtained should be corrected by applying the following formula

Where

M is the migration in mg/kg;

m is the mass in mg of substance released by the sample as determined by the

migration test;

a 1 is the surface area in dm² of the sample in contact with the foodstuff or

simulant during the migration test;

a 2 is the surface area in dm² of the material or article in real conditions of use;

q is the quantity in grams of foodstuff in contact with the material or article in

real conditions of use.

3. Correction of specific migration in foods containing more than 20 % fat by

the Fat Reduction Factor (FRF)

‘Fat Reduction Factor’ (FRF) is a factor between 1 and 5 by which measured

migration of lipophilic substances into a fatty food or stimulant D and its

substitutes shall be divided before comparison with the specific migration

limits.

General rules

Substances considered ‘lipophilic’ for the application of the FRF are listed in

Part IVa of this Schedule. The specific migration of lipophilic substances in

mg/kg (M) shall be corrected by the FRF variable between 1 and 5 (MFRF).

The following equations shall be applied before comparison with the legal

limit

M FRF = M/FRF

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

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

(a)

when the material or article is or is intended to be brought in contact

with food containing less than 20 % fat;

(b)

when the material or article is or is intended to be brought in contact

with food intended for infants and young children as defined by

Directives 91/321/EEC and 96/5/EC;

(c)

for substances in the Community lists in Annexes II and III having a

restriction in column (4) SML= ND or non-listed substances used

behind a plastic functional barrier with a migration limit of 0,01

mg/kg;

(d)

for materials and articles for which it is impracticable to estimate the

relationship between the surface area and the quantity of food in

contact therewith, for example due to their shape or use, and the

migration is calculated using the conventional surface area/volume

conversion factor of 6 dm 2 /kg.

This correction by the FRF is applicable under certain conditions in the

following case

For containers and other fillable articles with a capacity of less than 500

millilitres or more than 10 litres and for sheets and films in contact with

foods containing more than 20 % fat, either the migration is calculated as

concentration in the food or food simulant (mg/kg) and corrected by the

FRF, or it is re-calculated as mg/dm2 without applying the FRF. If one of

the two values is below the SML, the material or article shall be considered

in compliance.

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

the overall migration limit.

4. Correction of specific migration in food simulant D

The specific migration of lipophilic substances into simulant D and its

substitutes shall be corrected by the following factors

(a)

the reduction factor referred to in point 3 of the Annex to Directive

85/572/EEC, hereinafter termed simulant D Reduction Factor (DRF).

The DRF may not be applicable when the specific migration into

simulant D is higher than 80 % of the content of the substance in the

finished material or article (for example thin films). Scientific or

experimental evidence (for example testing with the most critical

foods) is required to determine whether the DRF is applicable. It is

also not applicable for substances in the Community lists having a

restriction in column (4) SML = ND or non-listed substances used

behind a plastic functional barrier with a migration limit of 0,01

mg/kg.

(b)

the FRF is applicable to migration into simulants, provided the fat

content of the food to be packed is known and the requirements

mentioned in paragraph 4 (a) are fulfilled.

(c)

the Total Reduction Factor (TRF) is the factor, with a maximum value

of 5, by which a measured specific migration into simulant D or a

substitute shall be divided before comparison with the legal limit. It is

obtained by multiplying the DRF by the FRF, when both factors are

applicable.

5. The determination of migration is carried out on the material or article or, if

that is impracticable, using either specimens taken from the material or article

or, where appropriate, specimens representative of this material or article.

The sample shall be placed in contact with the foodstuff or simulant in a

manner representing the contact conditions in actual use. For this purpose, the

test shall be performed in such a way that only those parts of the sample

intended to come into contact with foodstuffs in actual use will be in contact

with the foodstuff or simulant. This condition is particularly important in the

case of materials and articles comprising several layers, for closures, etc.

The migration testing of caps, gaskets, stoppers or similar devices for sealing

must be carried out on these articles by applying them to the containers for

which they are intended in a manner which corresponds to the conditions of

closing in normal or foreseeable use.

It shall in all cases be permissible to demonstrate compliance with migration

limits by the use of a more severe test.

6. In accordance with the provisions set out in paragraphs 30 to 33 of this

Schedule, the sample of the material or article is placed in contact with the

foodstuff or appropriate simulant for a period and at a temperature which are

chosen by reference to the contact conditions in actual use, in accordance with

the rules laid down in the Sixth and Seventh Schedules to these regulations. At

the end of the prescribed time, the analytical determination of the total

quantity of substances (overall migration) and/or the specific quantity of one

or more substances (specific migration) released by the sample is carried out

on the foodstuff or simulant.

7. Where a material or article is intended to come into repeated contact with

foodstuffs, the migration test(s) shall be carried out three times on a single

sample in accordance with the conditions laid down in the Sixth Schedule

using another sample of the food or simulant(s) on each occasion. Its

compliance shall be checked on the basis of the level of the migration found in

the third test. However, if there is conclusive proof that the level of the

migration does not increase in the second and third tests and if the migration

limit(s) is (are) not exceeded on the first test, no further test is necessary.

8. Caps, lids, gaskets, stoppers and similar sealing articles

(a)

If the intended use is known, such articles shall be tested by applying

them to the containers for which they are intended under conditions of

closure corresponding to the normal or foreseeable use. It is assumed

that these articles are in contact with a quantity of food filling the

container. The results shall be expressed in mg/kg or mg/dm 2 in

accordance to the rules of paragraphs 7 and 24 of this Schedule

taking into account the whole contact surface of sealing article and

container.

(b)

If the intended use of these articles is unknown, such articles shall be

tested in a separate test and the result be expressed in mg/article. The

value obtained shall be added, if appropriate, to the quantity migrated

from the container for which it is intended to be used.

Special provisions relating to overall migration

9. If the aqueous simulants specified in the Sixth and Seventh Schedules are

used, the analytical determination of the total quantity of substances released

by the sample may be carried out by evaporation of the simulant and weighing

of the residue.

If rectified olive oil or any of its substitutes is used, the procedure given below

may be followed.

The sample of the material or article is weighed before and after contact with

the simulant. The simulant absorbed by the sample is extracted and

determined quantitatively. The quantity of simulant found is subtracted from

the weight of the sample measured after contact with the simulant. The

difference between the initial and corrected final weights represents the overall

migration of the sample examined.

Where a material or article is intended to come into repeated contact with

foodstuffs and it is technically impossible to carry out the test described in

paragraph 8, modifications to that test are acceptable, provided that they

enable the level of migration occurring during the third test to be determined.

One of these possible modifications is described below.

The test is carried out on three identical samples of the material or article. One

of these shall be subjected to the appropriate test and the overall migration

determined (M 1 ). The second and third samples shall be subjected to the same

conditions of temperature but the period of contact shall be two and three

times that specified and overall migration determined in each case (M 2 and

M 3 , respectively).

The material or article shall be deemed to be in compliance provided that

either M 1 or M 3 - M 2 do not exceed the overall migration limit.

10. A material or article that exceeds the overall migration limit by an amount not

greater than the analytical tolerance mentioned below should therefore be

deemed to be in compliance with this Schedule.

The following analytical tolerances have been observed

20 mg/kg or 3 mg/dm 2 in migration tests using rectified olive

(a)

oil or substitutes,

12 mg/kg or 2 mg/dm 2 in migration tests using the other

(b)

simulants referred to in the Sixth and Seventh Schedules.

11. Without prejudice to the provisions of paragraph 7 of the Sixth Schedule,

migration tests using rectified olive oil or substitutes shall not be carried out to

check compliance with the overall migration limit in cases where there is

conclusive proof that the specified analytical method is inadequate from a

technical standpoint.

In any such case, for substances exempt from specific migration limits or other

restrictions in the list provided in Part II of this Schedule, a generic specific

migration limit of 60 mg/kg or 10 mg/dm 2 , according to the case, is applied.

However, the sum of all specific migrations determined shall not exceed the

overall migration limit.

PART II

LIST OF MONOMERS AND OTHER STARTING SUBSTANCES WHICH MAY BE

USED IN THE MANUFACTURE OF PLASTIC MATERIALS AND ARTICLES

GENERAL INTRODUCTION

1. This Part contains the list of monomers or other starting substances. The list

includes

(a)

substances undergoing polymerisation, which includes

polycondensation, polyaddition or any other similar process, to

manufacture macromolecules,

(b)

natural or synthetic macromolecular substances used in the

manufacture of modified macromolecules, if the monomers or the

other starting substances required to synthesise them are not included

in the list,

(c)

substances used to modify existing natural or synthetic substances.

2. The following substances are not included even if they are intentionally used

and are authorised

(a)

salts (including double salts and acid salts) of aluminium, ammonium,

calcium, iron, magnesium, potassium and sodium of authorised acids,

phenols or alcohols. However, names containing “… acid(s), salts”

appear in the lists, if the corresponding free acid(s) is (are) not

mentioned;

(b)

salts (including double salts and acid salts) of zinc of authorised acids,

phenols or alcohols. For these salts a Group SML = 25 mg/kg

(expressed as Zn) apply. The same restriction for Zn applies to

(i)

substances whose name contains “… acid(s), salts”

which appear in the lists, if the corresponding free

acid(s) is (are) not mentioned,

(ii)

substances referred to in note 38 of Annex VI. to

Directive 2002/72/EC.

3. The list also does not include the following substances although they may be

present

(a)

substances which could be present in the finished product as

(i)

impurities in the substances used,

(ii)

reaction intermediates,

(iii)

decomposition products;

(b)

oligomers and natural or synthetic macromolecular substances

as well as their mixtures, if the monomers or starting

substances required to synthesise them are included in the list;

(c)

mixtures of the authorised substances.

The materials and articles, which contain the substances indicated under points

(a),(b) and (c) shall comply with the requirements stated in regulation 3.1.

4. Substances shall be of good technical quality as regards the purity criteria.

5. The list contains the following information

(a)

column 1 (Ref. No): the EEC packaging material reference

number of the substances on the list,

(b)

column 2 (CAS No): the CAS (Chemical Abstracts Service)

registry number,

(c)

column 3 (Name): the chemical name,

(d)

column 4 (Restrictions and/or specifications)

These may include

(i)

specific migration limit (SML),

(ii)

maximum permitted quantity of the substance in the finished

material or article (QM),

(iii)

maximum permitted quantity of the substance in the finished

material or article expressed as mg per 6 dm 2 of the surface in

contact with foodstuffs (QMA),

(iv)

any other restriction specifically mentioned,

(v)

any type of specifications related to the substance or to the

polymer.

6. If a substance appearing on the list as an individual compound is also covered

by a generic term, the restrictions applying to this substance shall be those

indicated for the individual compound.

7. Where there is any inconsistency between the CAS number and the chemical

name, the chemical name shall take precedence over the CAS number. If there

is an inconsistency between the CAS number reported in Einecs and the CAS

Registry, the CAS number in the CAS Registry shall apply.

8. A number of abbreviations or expressions are used in column 4 of the table,

the meanings of which are as follows

DL = Detection limit of the method of analysis;

FP = Finished material or article;

NCO = Isocyanate moiety;

ND = not detectable. For the purpose of these regulations ‘not detectable’

means that the substance should not be detected by a validated method of

analysis which should detect it at the detection limit (DL) specified. If such a

method does not currently exist, an analytical method with appropriate

performance characteristics at the detection limit may be used, pending the

development of a validated method;

QM = Maximum permitted quantity of the ‘residual’ substance in the material

or article. For the purpose of this Schedule the quantity of the substance in the

material or article shall be determined by a validated method of analysis. If

such a method does not currently exist, an analytical method with appropriate

performance characteristics at the specific limit may be used, pending the

development of a validated method;

QM(T) = Maximum permitted quantity of the ‘residual’ substance in the

material or article expressed as total of moiety or substance(s) indicated. For

the purpose of this Schedule the quantity of the substance in the material or

article should be determined by a validated method of analysis. If such a

method does not currently exist, an analytical method with appropriate

performance characteristics at the specified limit may be used, pending the

development of a validated method;

QMA= Maximum permitted quantity of the ‘residual’ substance in the

finished material or article expressed as mg per 6 dm 2 of the surface in contact

with foodstuffs. For the purpose of this Schedule the quantity of the substance

in the surface of the material or article should be determined by a validated

method of analysis. If such a method does not currently exist, an analytical

method with appropriate performance characteristics at the specified limit may

be used, pending the development of a validated method;

QMA(T) = Maximum permitted quantity of the ‘residual’ substance in the

material or article expressed as mg of total of moiety or substance(s) indicated

per 6 dm² of the surface in contact with foodstuffs. For the purpose of this

Schedule the quantity of the substance in the surface of the material or article

should be determined by a validated method of analysis. If such a method does

not currently exist, an analytical method with appropriate performance

characteristics at the specified limit may be used, pending the development of

a validated method;

SML = Specific migration limit in food or in food simulant, unless it is

specified otherwise. For the purpose of this Schedule the specific migration of

the substance should be determined by a validated method of analysis. If such

a method does not currently exist, an analytical method with appropriate

performance characteristics at the specified limit may be used, pending the

development of a validated method;

SML (T) = Specific migration limit in food or in food simulant expressed as

total of moiety or substance(s) indicated. For the purpose of this Schedule the

specific migration of the substances should be determined by a validated

method of analysis If such a method does not currently exist, an analytical

method with appropriate performance characteristics at the specified limit may

be used, pending the development of a validated method.

Section A

List of authorised monomers and other starting substances

As stipulated by Section A of Annex II of Commission Directive 2002/72/EC (OJ L

220, 15.08.2002, p. 18-58), as amended by the Directives mentioned hereunder

1. Commission Directive 2004/1/EC (OJ L 7, 13.01.2004, p. 45)

2. Commission Directive 2004/19/EC (OJ L 71, 10.03.2004, p. 8-21)

3. Commission Directive 2005/79/EC (OJ L 302, 19.11.2005, p. 35-45)

4. Commission Directive 2007/19/EC (OJ L 91, 31.3.2007, p. 17)

Copies of the above mentioned Annex shall be made available to the general

public by the Directorate responsible for Foodstuffs within the Malta Standards

Authority.

Section B

List of monomers and other starting substances which may continue to be used

pending a decision on inclusion in Section A

As stipulated by Section B of Annex II of Commission Directive 2002/72/EC (OJ L

220, 15.08.2002, p. 18-58), as amended by the Directives mentioned hereunder

1. Commission Directive 2004/1/EC (OJ L 7, 13.01.2004, p. 45)

2. Commission Directive 2004/19/EC (OJ L 71, 10.03.2004, p. 8-21)

3. Commission Directive 2005/79/EC (OJ L 302, 19.11.2005, p. 35-45)

4. Commission Directive 2007/19/EC (OJ L 91, 31.3.2007, p. 17)

Copies of the above mentioned Annex shall be made available to the general

public by the Directorate responsible for Foodstuffs within the Malta Standards

Authority.

PART III

INCOMPLETE LIST OF ADDITIVES WHICH MAY BE USED IN THE

MANUFACTURE OF PLASTIC MATERIALS AND ARTICLES

GENERAL INTRODUCTION

1. This Part contains the list of

Substances which are incorporated into plastics to achieve a technical

effect in the finished product, including “polymeric additives”. They

are intended to be present in the finished articles;

substances used to provide a suitable medium in which polymerisation

occurs.

For the purposes of this Part, the substances referred to in (a) and (b) are

hereinafter referred to as “additives”.

For the purpose of this Part, “Polymeric additives” means any polymer and/or

prepolymer and/or oligomer which may be added to plastics in order to

achieve a technical effect but which cannot be used in absence of other

polymers as the main structural component of finished materials and articles.

It includes also substances which may be added to the medium in which

polymerisation occurs.

The list does not include

the substances which directly influence the formation of polymers;

colorants;

solvents.

2. The following substances are not included even if they are intentionally used

and are authorised

(a)

salts (including double salts and acid salts) of aluminium, ammonium,

calcium, iron, magnesium, potassium and sodium of authorised acids,

phenols or alcohols. However, names containing “… acid(s), salts”

appear in the lists, if the corresponding free acid(s) is (are) not

mentioned;

(b)

salts (including double salts and acid salts) of zinc of authorised acids,

phenols or alcohols. For these salts a Group SML = 25 mg/kg

(expressed as Zn) apply. The same restriction for Zn applies to

(i)

substances whose name contains “… acid(s), salts”

which appear in the lists, if the corresponding free

acid(s) is (are) not mentioned,

(ii)

substances referred to in note 38 of Annex VI. of

Commission Directive 2002/72/EC as amended.

3. The list does not include the following substances although they may be

present

(a)

substances which could be present in the finished product such as

(i)

impurities in the substances used,

(ii)

reaction intermediates,

(iii)

decomposition products;

(b)

mixtures of the authorised substances.

The materials and articles which contain the substances indicated in (a) and (b)

shall comply with the requirements stated in regulation 3.1.

4. Substances shall be of good technical quality as regards the purity criteria.

5. The list contains the following information

(a)

column 1 (Ref. No): the EEC packaging material reference

number of the substances on the list,

(b)

column 2 (CAS No): the CAS (Chemical Abstracts Service)

registry number,

(c)

column 3 (Name): the chemical name,

(d)

column 4 (Restrictions and/or specifications). These may

include

(i)

specific migration limit (SML),

(ii)

maximum permitted quantity of the substance in the finished

material or article (QM),

(iii)

maximum permitted quantity of the substance in the finished

material or article expressed as mg per 6 dm 2 of the surface in

contact with foodstuffs (QMA),

(iv)

any other restriction specifically mentioned,

(v)

any type of specifications related to the substance or to the

polymer.

6. If a substance appearing on the list as an individual compound is also covered

by a generic term, the restrictions applying to this substance shall be those

indicated for the individual compound.

7. Where there is any inconsistency between the CAS number and the chemical

name, the chemical name shall take precedence over the CAS number. If there

is an inconsistency between the CAS number reported in EINECS and the

CAS registry, the CAS number in the CAS registry shall apply.

Section A

Incomplete list of additives fully harmonised at Community level

As stipulated by Annex III of Commission Directive 2002/72/EC (OJ L 220,

15.08.2002, p.18-58), as amended by the Directives mentioned hereunder

1. Commission Directive 2004/1/EC (OJ L 7, 13.01.2004, p. 45)

2. Commission Directive 2004/19/EC (OJ L 71, 10.03.2004, p. 8-21)

3. Commission Directive 2005/79/EC (OJ L 302, 19.11.2005, p. 35-45)

4. Commission Directive 2007/19/EC (OJ L 91, 31.3.2007, p. 17)

Copies of the above mentioned Annex shall be made available to the general

public by the Directorate responsible for Foodstuffs within the Malta Standards

Authority.

Section B

Incomplete list of additives referred to in paragraph 11 of this Schedule

As stipulated by Annex III of Commission Directive 2002/72/EC (OJ L 220,

15.08.2002, p. 18-58), as amended by the Directives mentioned hereunder

1. Commission Directive 2004/1/EC (OJ L 7, 13.01.2004, p. 45)

2. Commission Directive 2004/19/EC (OJ L 71, 10.03.2004, p. 8-21)

3. Commission Directive 2005/79/EC (OJ L 302, 19.11.2005, p. 35-45)

4. Commission Directive 2007/19/EC (OJ L 91, 31.3.2007, p. 17)

Copies of the above mentioned Annex shall be made available to the general public

by the Directorate responsible for Foodstuffs within the Malta Standards Authority.

PART IV

PRODUCTS OBTAINED BY MEANS OF BACTERIAL FERMENTATION

As stipulated by Annex IV of Commission Directive 2002/72/EC (OJ L 220,

15.08.2002, p. 18-58), as amended by the Directives mentioned hereunder

1. Commission Directive 2004/1/EC (OJ L 7, 13.01.2004, p. 45)

2. Commission Directive 2004/19/EC (OJ L 71, 10.03.2004, p. 8-21)

Copies of the above mentioned Annex shall be made available to the general

public by the Directorate responsible for Foodstuffs within the Malta Standards

Authority.

PART IVa

LIPOPHILIC SUBSTANCES FOR WHICH THE FRF APPLIES

As stipulated by Annex IVa of Commission Directive 2007/19/EC (OJ L 91,

31.3.2007, p. 17).

Copies of the above mentioned Annex shall be made available to the general

public by the Directorate responsible for Foodstuffs within the Malta Standards

Authority.

PART V

SPECIFICATIONS

Part A: General Specifications

Plastic material and articles shall not release primary aromatic amines in a detectable

quantity (DL = 0,01 mg/kg of food or food simulant). The migration of the primary

aromatic amines appearing in the lists in Parts II and III of this Schedule is excluded

from this restriction.

Part B: Other Specifications

As stipulated by Part B of Annex V of Commission Directive 2002/72/EC (OJ L 220,

15.08.2002, p. 18-58), as amended by the Directives mentioned hereunder

1. Commission Directive 2004/1/EC (OJ L 7, 13.01.2004, p. 45)

2. Commission Directive 2004/19/EC (OJ L 71, 10.03.2004, p. 8-21)

3. Commission Directive 2005/79/EC (OJ L 302, 19.11.2005, p. 35-45)

4. Commission Directive 2007/19/EC (OJ L 91, 31.3.2007, p. 17)

Copies of the above mentioned Annex shall be made available to the general public

by the Directorate responsible for Foodstuffs within the Malta Standards Authority.

PART VI

NOTES RELATED TO THE COLUMN ‘RESTRICTIONS AND/OR

SPECIFICATIONS’

As stipulated by Annex VI of Commission Directive 2002/72/EC (OJ L 220,

15.08.2002, p. 18-58), as amended by the Directives mentioned hereunder

1. Commission Directive 2004/1/EC (OJ L 7, 13.01.2004, p. 45)

2. Commission Directive 2004/19/EC (OJ L 71, 10.03.2004, p. 8-21)

3. Commission Directive 2005/79/EC (OJ L 302, 19.11.2005, p. 35-45)

4. Commission Directive 2007/19/EC (OJ L 91, 31.3.2007, p. 17)

Copies of the above mentioned Annex shall be made available to the general

public by the Directorate responsible for Foodstuffs within the Malta Standards

Authority.

PART VIa

DECLARATION OF COMPLIANCE

The written declaration referred to in paragraph 37 of this Schedule shall contain the

following information

(1)

the identity and address of the business operator which manufactures

or imports the plastic materials or articles or the substances intended

for the manufacturing of those materials and articles;

(2)

the identity of the materials, the articles or the substances intended for the

manufacturing of those materials and articles;

(3)

the date of the declaration;

(4)

confirmation that the plastic materials or articles meet relevant requirements

laid down in this Schedule and Regulation (EC) No 1935/2004;

(5)

adequate information relative to the substances used for which restrictions

and/or specifications are in place under this Schedule to allow the

downstream business operators to ensure compliance with those restrictions;

(6)

adequate information relative to the substances which

are subject to a restriction in food, obtained by

experimental data or theoretical calculation about the

level of their specific migration and, where appropriate,

purity criteria in accordance with the Sweeteners for use

in Foodstuffs Regulations, 2005, the Use of Colours in

Foodstuffs Regulations, 1995 and the Permitted Food

Additives Regulations, 2005, to enable the user of these

materials or articles to comply with the relevant

L.N. 30 of 2005

Community provisions or, in their absence, with

L.N. 107 of 1995

L.N. 54 of 2005

national provisions applicable to food;

(7)

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

(i)

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

(ii)

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

(iii)

ratio of food contact surface area to volume used to establish the

compliance of the material or article;

(8)

when a plastic functional barrier is used in a plastic multi-layer material or

article, the confirmation that the material or article complies with the

requirements of paragraphs 27, 28 and 29 of this Schedule.

The written declaration shall permit an easy identification of the materials, articles or

substances for which it is issued and shall be renewed when substantial changes in the

production bring about changes in the migration or when new scientific data are

available.”.

4. For the Seventh Schedule to the principal regulations, there Amends

the

Seventh Schedule to

shall be substituted the following>-

the principal

regulations.

“SEVENTH SCHEDULE

List Of Simulants To Be Used for Testing Migration of Constituents of

Plastic Materials And Articles Intended To Come Into Contact with Foodstuffs

1. This Schedule constitutes a specific provision within the meaning of

regulation 4.

2. The simulants to be used for testing migration of the constituents of plastic

materials and articles intended to come into contact with a single foodstuff or

specific group of foodstuffs and the concentration of these simulants shall be

those indicated in the Annex to Council Directive 85/572/EEC (OJ No L 372,

31.12.1985, p.14), as amended by the Directive/s mentioned hereunder

1. Commission Directive 2007/19/EC (OJ L 91, 31.3.2007, p. 17)

Copies of the above mentioned Annex shall be made available to the general

public by the Directorate responsible for Foodstuffs within the Malta

Standards Authority.

3. Notwithstanding paragraph 2, the list of substances or materials whose use is

authorized to the exclusion of all others may lay down procedures testing

migration of particular constituents of plastic materials and articles which

differ from those laid down in the Annex to Council Directive 85/572/EEC

where this is appropriate.”.