Regulations, 2009

L.N. 102 of 2009

FOOD SAFETY ACT

(CAP. 449)

Materials in Contact with Foodstuffs (Amendment)

Regulations, 2009

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, 2009, 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 7

March, 2009.

(1) Regulation 3 implements the provisions of

Commission Directive 2008/39/EC of 6 March 2008 amending

Directive 2002/72/EC relating to plastic materials and articles

intended to come into contact with food.

(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 2008/39/EC, shall

be permitted as from 7 March, 2009.

(3) The manufacture and importation into the

Community of plastic materials and articles intended to come into

contact with food which does not comply with Directive 2002/72/

EC, as amended by Directive 2008/39/EC shall be prohibited as

from 7th March, 2010.

For the Fifth Schedule to the principal regulations, there

shall be substituted the following:-

Substitutes the Fifth Schedule to the principal regulations.

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

the following:-

“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.

B

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

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

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

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.

(1)

A Community list of additives which may be used for the

manufacture of plastic materials and articles, together with the

restrictions and/or specifications on their use, is set out in Part III

of this Schedule.

(2)

As from 1 January 2010, only additives included in the

Community list of additives may be used for the manufacture of

plastic materials and articles (positive list).

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.

By derogation from paragraph 10(2), additives not included in the

Community list referred to in that paragraph may continue to be used after

B

1 January 2010 for as long as they are included in the provisional list and

provided that the Directorate responsible for Foodstuffs within the Malta

Standards Authority is informed in writing.

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(1), 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(1) 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(1) 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 18 shall be accompanied

by a written declaration containing the information referred to in

paragraph 36.

By way of derogation from paragraph 18, when the substances referred to

in point (a) of paragraph 18 is 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 25, 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.

B

The migration of the substances referred to in paragraph 26(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 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 26(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 29 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 29 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 29 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.

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

OJ 196, 16.8.1967, p. 1.

Notwithstanding paragraph 29, 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.

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 34 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.

B

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

And

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

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

(a)

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

contact with food containing less than 20 % fat;

(b)

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

contact with food intended for infants and young children as

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

(c)

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

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

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

mg/kg;

(d)

for materials and articles for which it is impracticable to estimate

the relationship between the surface area and the quantity of food

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

migration is calculated using the conventional surface area/volume

conversion factor of 6 dm 2 /kg.

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

following case

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

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

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

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

FRF, or it is re-calculated as mg/dm 2 without applying the FRF. If one of

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

considered in compliance.

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

the overall migration limit.

4. Correction of specific migration in food simulant D

B

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 29 to 32 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 23

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.

B

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,

B

(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,

B

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)

5. Commission Directive 2008/39/EC (OJ L 63, 7.3.2008, p. 6–13)

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.

B

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)

5. Commission Directive 2008/39/EC (OJ L 63, 7.3.2008, p. 6–13)

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)

5. Commission Directive 2008/39/EC (OJ L 63, 7.3.2008, p. 6–13)

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)

B

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), as amended by the Directive/s mentioned hereunder

1. Commission Directive 2008/39/EC (OJ L 63, 7.3.2008, p. 6–13)

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)

5. Commission Directive 2008/39/EC (OJ L 63, 7.3.2008, p. 6–13)

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)

5. Commission Directive 2008/39/EC (OJ L 63, 7.3.2008, p. 6–13)

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 36 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;

L.N. 30 of 2005

(6)

adequate information relative to the substances which

L.N. 107 of 1995

are subject to a restriction in food, obtained by

L.N. 54 of 2005

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 Community

B

provisions or, in their absence, with national provisions applicable to

food;

(7)

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

(i)

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

(ii)

time and temperature of treatment and storage in contact with the

food

(iii) ratio of food contact surface area to volume used to establish the

compliance of the material or article;

(8)

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

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

requirements of paragraphs 26, 27 and 28 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”.

B

€2.14