Minimum Safety Requirements For Materials And Articles In Contact With Food

Original Language Title: Obligātās nekaitīguma prasības materiāliem un priekšmetiem, kas nonāk saskarē ar pārtiku

Read the untranslated law here: https://www.vestnesis.lv/ta/id/141772

Cabinet of Ministers Regulations No. 637, Riga, 1 august 2006 (pr. Nr. 40 50) minimum safety requirements on the materials and articles in contact with food have been issued under the food surveillance article 10 of the law, the first paragraph i. General questions 1. lays down minimum safety requirements for materials and articles in contact with food (hereinafter referred to as materials and articles).
2. General requirements for materials and articles in contact with food, the European Parliament and of the Council of 27 October 2004, Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food and repealing directives 80/590/EEC and 89/109/EEC (hereinafter Regulation No 1935/2004).
3. to use the material and the production of the subject matter that is not referred to in these regulations shall comply with Regulation No 1935/2004 the procedures laid down in article 9, submitting an application to the food and veterinary service food Center. Materials and articles in compliance with the requirements of this regulation controls the food and veterinary service.
4. restrictions on the use of epoxy derivatives in materials and articles intended to come into contact with foodstuffs, laid down in Commission on 18 November 2005, Regulation (EC) No 1895/2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs.
II. Plastic materials and articles 5. plastic materials and articles are materials and items, as well as parts thereof consisting only of plastic or are made of two or more interconnected only from plastic created layers.
6. Plastics are organic macromolecular compounds obtained by polymerization, polycondensation, polyaddition in or other similar process from molecules with a lower molecular weight or by chemical modification of natural macromolecules. Such macromolecular coupling can add other substances or preparations. The plastic does not believe: 6.1. coated or uncoated regenerated cellulose film;
6.2. elastomers and natural and synthetic rubber;
6.3. paper and paperboard, whether modified or not by the addition of plastics;
6.4. surface coatings obtained from paraffin resin (also from synthetic paraffin resins) or from the resin and microcrystalline cellulose resin mixtures or mixtures of resin and plastic;
6.5. ion-exchange resins;
6.6. Silicones.
7.No plastic material or object surface area of one per square decimetre of food may migrate up to 10 milligrams of the constituents (total migration limit). However, the overall migration limit must not be greater than 60 milligrams per kilogram of food in the following cases: 7.1 the tanks with a capacity of 0.5-10 litres;
7.2. items which can be filled, but it is not possible to determine the surface area in contact with foodstuffs;
7.3. lids, seals, Stoppers and similar fasteners.
8. the plastic material in the production of objects and are allowed to use this provision in annex 1 and 2 of the raw material additives referred to in the annex, subject to the relevant limitations and specifications, as well as 11 of these regulations and paragraph 15 of that substance. If any raw materials or additives, Chemical Abstracts Service registry log information service referred to in the register number does not match its chemical name, chemical is taken into account. If any raw materials or additives, Chemical Abstracts Service registry log information service referred to in the register number does not match the existing European trade in chemicals listed in the register number, then takes into account the raw material or additive Chemical Abstracts Service registry log information service number.
9. Bacterial fermentation process for products used in contact with food, down this provision in annex 3.
10. Using the material in the production of objects and of additives permitted for use in Latvia as food additives or flavourings manufacturers ensure that their migration in food does not reach the quantities that have a technological function in the finished product, or exceed regulations on food additives and flavourings, the quantity laid down. Distributing such materials and articles be accompanied by wholesale, manufacturer's declaration issued.
11. Plastic materials and articles in the list of authorised raw materials production (annex 1) covers the macromolecular substances synthesis process inputs, as well as a modified macromolecular substances used in the manufacture of natural or synthetic macromolecular substances if it is necessary for the synthesis of monomers or other starting substances are not included in that list, and natural or synthetic macromolecular substances used to modify substances.
12. Plastic materials and articles in the list of authorised raw materials production (annex 1) are not included in the following plastic materials in the production of objects and permitted substances: 12.1. acid, phenol or alcohol of aluminium, ammonium, calcium, iron, magnesium, potassium and sodium salts (including double salts and acid salts). The term "… acid (s), salt (s)" is used in the list, if the corresponding free acid is not mentioned in the list;
12.2. the connections which may be present in the final food substances used, reaction and degradation products of intermediate products;
12.3. oligomers and natural or synthetic macromolecular substances and their mixtures, if the monomers or feedstocks for fusion is included in the list;
12.4. plastic materials and articles in the manufacture of mixtures of raw materials allowed;
12.5. acid-, phenol or alcohol zinc salts (including double salts and acid salts). These salts groups specific migration limit (SML) is 25 milligrams per kilogram (expressed as zinc) of food or food simulant. The same zinc limitation applies to those substances that contain the words "… acid (s), salt (s)", which is in the lists, if the corresponding free acid is not mentioned in the list.
13. If the plastic materials and articles in production of raw materials allowed list (annex 1) for the substance as a separate connection is also a generic term, the subject of the substances referred to in individual connection restrictions.
14. Plastic materials and articles in production allowed additives, including polymer additives (polymers and oligomers, prepolymers which can be added to plastics to achieve a technical effect but which alone without other polymers cannot be used on the finished material or article of the main ingredients), established in annex 2 of these rules. The additives are used as follows:

14.1. the plastic to achieve certain technical results in the finished product. These additives remain in the finished product;
14.2. provide suitable polymerization. 15. Plastic materials and articles in the list of authorised additives production (annex 2) are not included in the following plastic materials and in the manufacture of items authorized additives: 15.1 the substances which directly influence the formation of polymers, pigments and solvent process;
15.2. acid, phenol or alcohol of aluminium, ammonium, calcium, iron, magnesium, potassium and sodium salts (including double salts and acid salts). The term "… acid (s), salt (s)" is used in the list, if the corresponding free acid is not listed;
15.3. substances that may be present in the raw materials used in the finished product, the reaction intermediates impurities or degradation products;
15.4. plastic materials and articles in the manufacture of mixtures of substances authorized;
15.5. acid-, phenol or alcohol zinc salts (including double salts and acid salts). These salts groups specific migration limit (SML) is 25 milligrams per kilogram (expressed as zinc) of food or food simulant. This zinc limitation applies to substances that contain the words "… acid (s), salt (s)", which is in the lists if the corresponding free acid is not mentioned in the list.
16. plastic materials and articles which contain this rule 12.2, 12.3, 12.4, 15.3 and 15.4. the substances referred to in (a), comply with the minimum safety requirements. Specifications for certain of these rules 1, 2 and 3 substances listed in the annex are laid down in annex 4.
17. Plastic materials and articles for the determination of migration of ingredients in food or in food simulant (hereinafter-migration test) is carried out in accordance with the provisions of annex 5 of certain materials or objects or their analogues. If it is not possible to determine where the plastic material or object level of migration of the components of food, the level of the migration down the food simulants.
18. The migration tests are to be carried out under conditions which comply with the actual or anticipated in the plastic material or article, or part of the conditions of use, as well as provide the migration tests at more stringent conditions.
19. at the end of the migration test shall be determined from the analysis of plastic material or object, or any part of the migrant total quantity of substances in food or substitutes (total migration) or one or more of the plastic material or article, or part of the quantity migrated or substitutes (specific migration).
20. Comparing migration test results, the specific weight of the simulant is conditionally accepted for one. Migrated substances milligrams per litre of simulant numerically match migrated substances milligrams per kilogram of the food.
21. These rules 1 and 2 in the annex to the specific migration limits are expressed in milligrams per kilogram. The limit can also be expressed in milligrams per square decimetre: 21.1. tanks with a capacity of less than 0.5 litres or more than 10 litres;
21.2. plastic materials that cannot be refilled or that can not determine the ratio between the surface area of the material and the material in contact with the existing amount of food (for example, sheet, film). In those cases the specific migration limit concerned, expressed in milligrams per kilogram, and divide by 6 (conventional conversion factor), to express its milligrams per square decimetre.
22. plastic materials and articles complying with the minimum safety requirements, where the migration tests results obtained shall not exceed the limit of the joint migration more than 22.1.20 milligrams per kilogram or: 3miligram per square decimetre, migration, tests, which used olive oil rectified or its substitutes;
22.2.12 milligrams per kilogram or per square decimetre-2miligram in migration tests using the other simulants.
23. The migration tests are to be carried out in accordance with the provisions of annex 5, subject to the following conditions: 23.1. these terms used annex 5 referred to in chapter II of the simulant and referred to in chapter III migration test conditions;
23.2. If for technical reasons it is not possible to use this provision of the annex 5 referred to in chapter II of the simulant D shall be used this provision in chapter IV of annex 5, these fat substitutes (solvents);
23.3.5. these rules laid down in chapter V of the annex to the alternative tests are used, if the relevant conditions are fulfilled;
23.4. this rule 23.1., 24.2 and 24.3. in the cases referred to in paragraph is acceptable: 23.4.1. the migration tests to be carried out to reduce the number of circumstances in which the tests are carried out, according to scientific studies, is recognized as the most stringent;
23.4.2. not to carry out the migration tests if there is strong evidence that any foreseeable plastic material or item use migration limits cannot be exceeded.
24. Vinyl chloride monomer level in materials and subjects the quantity must not exceed 1 milligram per kilogram. Migration of vinyl chloride from plastic materials and objects in food. Vinyl chloride migration of plastic materials and articles in food control, using the method detection limit is 0.01 kilogram milligram.
25. Vinyl chloride monomer level in materials and the quantity of the subjects, as well as the possible migration of vinyl chloride in food determined in the laboratory, accredited according to the standard LVS EN ISO/IEC 17025:2005 "the competence of testing and calibration laboratories-General requirements" requirements in the field of food chemistry. The analyses shall be carried out using the rules referred to in annex 6 of the reference method. If for technical reasons it is not possible to determine the possible migration of vinyl chloride in food, determines the migration of vinyl chloride in food simulant according to annex 5 of these rules. The laboratory shall have the right to use other methods of analysis, if it can be shown that they reach as high limit of detection, precision and accuracy as referred to in annex 6 to the reference method.
26. the polyvinyl chloride (PVC) lid seals used for closing the jar, specific migration limit (SML) epoksidēt of soybean oil is 60 milligrams per kilogram of food or food simulant. Polyvinyl chloride (PVC) door seals, used a glass jar containers that are food for infants and young children, specific migration limit (SML) epoksidēt of soybean oil is 30 milligrams per kilogram of food or food simulant.
III. Ceramic articles

27. the subject of ceramic objects are made from inorganic substances in the mixture that contains much clay and silicate, and can be a small quantity of organic substances. This object is first created and then fired. It can also be glazed, enamelled or painted.
28. emphasises the ceramic object quantities of lead and cadmium from ceramic articles on the category must not exceed: 28.1. a quantity of lead and cadmium 0.8 milligrams per square decimetre of quantity of 0.07 milligrams per square decimetre-category 1 ceramic items (items that cannot be filled, or items that can be filled, the internal depth of which, measured from the lowest point to the horizontal plane passing through the upper rim, not greater than 25milimetr);
28.2. the lead quantity is 4, 0miligram per litre and the quantity of 0.3 milligrams of cadmium per litre – category 2 ceramic articles (the other articles which can be filled);
28.3. lead quantity 1, 5miligram per litre and the quantity of 0.1 milligrams of cadmium per litre – category 3 items (dishes for cooking (cooking), food packing and storage tanks with a capacity greater than three litres).
29. If the results obtained by determining the migration of lead and cadmium from ceramic articles in accordance with the provisions of annex 7, as well as at least three other analogue items (from the same production batch) analysis results does not exceed the provisions mentioned in paragraph 24 sizes, more than 50% of the ceramic object meets the minimum safety requirements.
30. If the subject matter of these ceramics consisting of rules 28.2. ceramic articles referred to, or 28.3. referred to ceramic dish (categories 2 and 3) and a ceramic lid (category 1), then the rate of lead and cadmium are attributable to the dish. Cover the container and the inner surface of the test separately and under the same conditions. Such quantities of lead and cadmium in the amount to apply only to the vessel's surface area or volume.
31. At all stages of marketing the ceramic articles intended to come into contact with foodstuffs shall be accompanied by a written declaration, which allows you to identify the item. The Declaration, if a substantial change in production causes changes in the migration of lead and cadmium. The Declaration must be drawn up by the manufacturer or the operator who registered in the European Union, and it contains the following information: 19.3. producer of ready-to-use product and the name and address of the importer;
31.2. ceramic product name;
31.3. the date of the Declaration;
19.5. acknowledgement of conformity of ceramics and those provisions of Regulation No 1935/2004.
32. the manufacturer of ceramics by the food and veterinary service request, produce evidence that the ceramic articles comply with the provisions of paragraph 28 of the migration of lead and cadmium. The attestation shall indicate the results of the analyses carried out, the test conditions and the name and address of the laboratory that performed the testing.
IV. material made of regenerated cellulose film 33. Regenerated cellulose film is a thin layer of material obtained from refined cellulose derived from recycled wood or cotton. To get a specific film, technological characteristics, the production process and mass, both on the surface of various additives can be added, and regenerated cellulose film may be: 33.1. no coverage;
33.2. the pulp;
33.3. with a plastic coating.
34. Regenerated cellulose film is used as a material in contact with food or which form part of the material in contact with food. This condition does not apply to regenerated cellulose synthetic protective cover.
35. Regenerated cellulose film with no coverage or coverage allowed the pulp produced only from the substances or groups of substances listed in annex 8 of this regulation, subject to the limits fixed in the annex, as well as substances used for painting (paints and pigments) or as adhesives, if validated chemical analysis show no migration of these substances in food or on its surface.
36. If the regenerated cellulose film for plastic coating, the coating to produce only from the substances or groups of substances referred to in this provision in chapter I of Annex 8, subject to the limits fixed in the annex. Plastic coated regenerated cellulose film allowed to produce only from the substances or groups of substances in accordance with the provisions of 1, 2, 3 and 4 set out in the annex. On regenerated cellulose film with coating also apply this rule 7, 21, 22 and 23 above.
37. Coated regenerated cellulose film with coating on one side or on both sides.
38. Regenerated cellulose film a printed surface must not come into contact with food.
V. rubber or elastomeric dummies and decoys 39. Rubber or elastomeric dummies and decoys are not allowed to distribute N-nitrosamines or substance that can be converted into N-nitrosamines. Saliva test solution, respecting the rules referred to in annex 9, must not be released N-nitrosamines or substances that can be converted into N-nitrosamines that can be determined by a validated method that matches that rule 9. the criteria set out in the annex. With this method you can determine the following: 39.1.0, 01miligram of all the N-nitrosamines from one kilogram of dummies and decoys parts made of rubber or elastomer;
39.2.0, 1miligram of all the N-nitrosamines-forming substances from one kilogram.
Vi. Paper and Board materials and articles 40. Paper and Board materials and articles shall not distribute more than 0.5 milligrams of cadmium from one kilogram of the material.
41. Paper and Board materials and articles shall not distribute more than 3 milligrams of lead from one kilogram of the material.
VII. Closing questions 42. Be declared unenforceable in the Cabinet of 9 June 1998, Regulation No 217 "minimum safety requirements on the materials and articles in contact with food" (Latvian journal, 1998, nr. 174; 2003; 2004, nr. 14, 68 no; 2005, 20, no 176, 210).
43. Until the new regulations and technical documents or the adoption of legislation relating to materials and articles made of wood (also from korķkok), metal or its alloys, paraffin or microcrystalline cellulose resin the resin, glass, textiles and rubber, are the existing standards and regulations, in so far as they do not conflict with the laws and regulations.

44. Plastic materials and articles which put up to 2 august 2005 and which contains AZODICARBONAMIDE as a blowing agent, can continue to propagate, if they are specified in the date of filling. The date of filling may be replaced by another indication, provided it allows you to define the date of filling. The news about the date of filling shall on request be given a food and veterinary service.
45. Glassware, which until 2006 November 19, filled with food for infants and young children and concluded with polyvinyl chloride (PVC) door seals, which do not comply with this provision the requirements of paragraph 26, can continue to propagate, where the containers are specified on the packaging date or reference, which allows the date of filling. The news about the date of filling shall on request be given a food and veterinary service.
46. Beginning with the November 19, 2007, prohibited the manufacture and import of plastic objects in Latvia, which come into contact with foodstuffs and which do not comply with this provision, paragraph 26.
47. for materials and articles used in the manufacture of additives other than those referred to in annex 3 of these rules, but which is used in one of the European Union or European economic area Member States, the applicant shall submit an application to the food and Veterinary Office no later than December 1, 2006, pursuant to the provisions of Regulation No 1935/2004 the procedures laid down in article 9. The application adds the data demonstrating the safety of the additives. The food and veterinary service supports submission of information received, the European food safety authority by 31 December 2006.
48.Ar 20 May 2007 has banned trade in and use of ceramic articles intended to come into contact with foodstuffs and which does not meet the requirements of this regulation.
Informative reference to European Union directives, the regulations include provisions resulting from: 1) Council of 30 January 1978 Directive 78/142/EEC on the approximation of the laws of the Member States relating to materials and articles which contain vinyl chloride monomer and intended to come into contact with foodstuffs;
2) Commission of 8 July 1980 of Directive 80/766/EEC laying down the Community method of analysis used for the official control of the vinyl chloride monomer level in materials and articles intended to come into contact with foodstuffs;
3) Commission of 29 April 1981 Directive 81/432/EEC laying down the Community method of analysis for the official control of vinyl chloride released by materials and articles into foodstuffs;
4) Commission of 18 October 1982 of Directive 82/711/EEC laying down the basic rules necessary for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs;
5) Council on 15 October 1984 directive 84/500/EEC on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs;
6) Council of 19 December 1985 of 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;
7) Commission of 15 March 1993 of Directive 93/10/EEC relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs;
8) Commission of 6 august 2002 Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs;
9) Commission July 29 1997 Directive 97/48/EC amending Council Directive 82/711/EEC laying down the basic rules necessary for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs;
10) Commission of 1 March 2004, Directive 2004/19/EC amending Directive 2002/72/EC relating to plastic materials and plastic articles intended to come into contact with foodstuffs;
11) Commission of 29 January 2004, Directive 2004/14/EC amending Directive 93/10/EEC relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs;
12) Commission of 6 January 2004, Directive 2004/1/EC amending Directive 2002/72/EC in respect of the use of azodicarbonamide as blowing agent;
13) Commission of 15 March 1993 of Directive 93/8/EEC amending Council Directive 82/711/EEC laying down the basic rules necessary for testing of the constituents of plastic materials and articles to verify the migration, which are intended to come into contact with foodstuffs;
14) Commission of 15 March 1993 of Directive 93/11/EEC on from elastomer or rubber teats and soothers of N-nitrosamines and N-nitrosatable substances;
15) Commission of 10 December 1993 directive 93/111/EC amending Directive 93/10/EEC of regenerated cellulose film for materials and articles intended to come into contact with foodstuffs;
16) Commission of 18 November 2005 Directive 2005/79/EC, amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs;
17) Commission of 29 April 2005 Directive 2005/31/EC, amending Council Directive 84/500/EEC as regards a declaration of compliance and performance criteria of the analytical method for ceramic articles intended to come into contact with foodstuffs.
Prime Minister a. Halloween Minister of Agriculture m. Roze Editorial Note: rules shall enter into force on 17 august 2006.
Annex 1-9 ZIP 233 kb