Key Benefits:
| Appendix 1 | Extraction measures which may be used for the processing of raw materials, food, food ingredients and food ingredients |
| Appendix 2 | Information to be supplied in the context of the approval of a food enzyme |
| Appendix 3 | Use of nitrites (E 249-250) to meat products. |
Completion of Statements Mv. for Food 1)
In accordance with § 8, § 9, § 49 and § 60 (3). 3, in the law of foodstuffs, cf. Law Order no. 250 of 8. March 2013 :
Area and Definitions
§ 1. This notice relates to :
1) means of extraction,
2) food enzymes,
3) food additives ;
4) technical aids and
5) flavourings for food.
§ 2. By means of an additional instrument, as mentioned in section 1, no. 1, in this notice, a solvent is understood to be used in an extractive process during the processing of raw materials, food or ingredients or ingredients of such products, which may be removed, but which may result in an unintended purpose, but the presence of residues of the substance or its transformation products in the food or food ingredient, technically unavoidable.
Paragraph 2. Any solvent means any substance that can be dissolved or any constituent part of a food, including any pollutant that exists in or on the food of the food.
§ 3. For the definition of food enzymes as referred to in section 1, no. I refer to Regulation (EC) No 2 of the European Parliament and of the Council. 1332/2008 of 16. In December 2008 on the food enzymes and amending Council Directive 83 /417/EEC, Council Regulation (EC) No 149/EC (EC) No 145.4. Regulation (EC) No 1493/1999, Directive 2000 /13/EC, Council Directive 2001 /112/EC and Regulation (EC) No 31, 258/97.
§ 4. For the definition of food additives and technical aids as referred to in section 1, no. The Regulation (EC) No 3 and 4 of the European Parliament and of the Council shall be referred to 1333/2008 of 16. December 2008 on food additives
§ 5. For the definition of flavourings as referred to in section 1, no. The Regulation (EC) No 5 is referred to in Article 5 of the European Parliament and 1334/2008 of 16. In December 2008, on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 2, 1601/91, Regulation (EC) No, Regulation (EC) No 2232/96, 110/2008 and Directive 2000 /13/EC.
Extraction measures
§ 6. Only the substances listed in Annex 1 may be used as additional instruments for the production of food and food ingredients, cf. however, paragraph 1 2.
Paragraph 2. Water, optionally added to surging substances, and food or food ingredients, may be used as extractioning agents.
§ 7. Exceptional agents must not contain any substance or other substances in quantities that are harmful to the environment.
Paragraph 2. Exceptional instruments shall not contain more than 1 mg of the arsis and 1 mg of lead per litre ; kg, unless otherwise specified by specific purity criteria.
Food enzymes
§ 8. The use of food enzymes must be approved by the Food Authority in accordance with the procedure set out in Annex 2.
Paragraph 2. However, food enzymes must be applied for six months after the application for authorisation has been submitted to the Food Authority.
Paragraph 3. In the cases where data have already been submitted and subsequently assessed and approved in another EU Member State after the SCF guidelines for presentation of data on food enzymes from 11. In April 1991 or following the EFSA guidelines for the risk assessment of food enzymes (Question No EFSA-Q 2007-080), and this may be documented for the Food Safety Board, they may have to do so in paragraph 1. However, the food enzymes referred to in paragraph 1 shall be taken three months after the documentation has been submitted to the Food Authority, cf. however, paragraph 1 4.
Paragraph 4. The Food Management Board may extend it in paragraph 1. The three mentioned period to 6 months, provided that they are justified.
Paragraph 5. This is a prerequisite for the application of paragraph 1. 1 4, that the FDA has not, prior to the application of the application of the food enzyme, has imposed no prior prohibition of the application of the food
Paragraph 6. An approved food enzyme may be used only in accordance with the information laid down in the application.
Paragraph 7. The Food Management Board may lay down conditions for the use of the food enzyme, including that the use is only permitted for a limited period.
Nitrit
§ 9. Nitrites (E 249-250) for meat products may be used only in accordance with the conditions laid down in Annex 3.
Engineering aids
§ 10. Technical aids must be used for food as long as the substances and use are health defenders, cf. However, section 11.
§ 11. The Food Safety Authority may decide on requirements for technical remedies in respect of :
1) use for certain food or food groups ;
2) specific purposes for use,
3) permissible residual residues in foodstuffs,
4) identity and purity ; and
5) approval.
Administrative and penalty provisions
§ 12. Products of herds which are legally manufactured and marketed in another EU Member State may be implemented in Denmark, regardless of the rules on herds in this notice.
Paragraph 2. Paragraph 1 shall not, however, apply to the substances referred to in sections 8 and section 9.
§ 13. Businesses processing or selling foods shall draw up written documentation on the use of herds for the whole or part of the company's product sortia.
Paragraph 2. For food additives which may be added to food after the quantum satis principle, the undertaking must provide written proof of the need for the quantity of each food additives used.
§ 14. With fine punishment, the one who :
1) is breaching section 6 (1). One, section 7, section 8, paragraph 8. One-three, paragraph 8, paragraph 8. 6 or sections 9-10,
2) will override the terms and conditions laid down in accordance with Article 8 (3). 7 or in section 11 or
3) is in breach of notification pursuant to Article 8 (3). 5.
Paragraph 2. The sentence may go to prison for two years if the infringement has been carried out by means of presets or gross negligence and the infringement is :
1) injury to public health or induced danger ; or
2) obtained or intended for the economic benefit of the person concerned itself or others, including in savings.
Paragraph 3. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.
§ 15. The penalty may be penalised by the penalty which is in breach of Articles 4 to 5, Articles 15 to 16, 20 or Article 21 to 24 of Regulation (EC) No 2 of the European Parliament and of the Council. 1333/2008 of 16. In December 2008 on food additives provided for.
Paragraph 2. The sentence may rise to prison for two years if the infringement has been carried out with a set of presets or by gross negligence and if there is a breach of the infringement proceedings ;
1) injury to human health or, therefore, hazard, or
2) obtained or intended for the economic benefit of the person concerned itself or others, including in savings.
Paragraph 3. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.
§ 16. The penalty is imposed on the person who contravening Article 4 (4). Article 5 (2). Paragraph 1-2 or 13 (1). Regulation 1-3 of Regulation (EC) No 2065/2003 of 10 of the European Parliament and of the Council of 10. In November 2003 on smoke flavourings used or intended for use in or on food, laid down.
Paragraph 2. The sentence may rise to prison for two years if the infringement has been carried out with a set of presets or by gross negligence and if there is a breach of the infringement proceedings ;
1) injury to human health or, therefore, hazard, or
2) obtained or intended for the economic benefit of the person concerned itself or others, including in savings.
Paragraph 3. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.
§ 17. The penalty shall be penalised by the penalty which contravening Articles 4 to 5 (6). 1-2, Article 7, Article 10 (cf. however, Articles 1 and 2 of Commission Regulation No 2, Regulation (EC) No 1334/2008 of 16 of the European Parliament and of the Council (EC) No 1334/2008 of the European Parliament and of the Council. In December 2008, on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 2, 1601/91, Regulation (EC) No, Regulation (EC) No 2232/96, 110/2008 and Directive 2000 /13/EC, which are used or intended for use in or on food, provided for.
Paragraph 2. The sentence may rise to prison for two years if the infringement has been carried out with a set of presets or by gross negligence and if there is a breach of the infringement proceedings ;
1) injury to human health or, therefore, hazard, or
2) obtained or intended for the economic benefit of the person concerned itself or others, including in savings.
Paragraph 3. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.
§ 18. The penalty is penalised by the penalty which violates Article 1 of Commission Regulation (EC) No 321/2012 of 9. in March 2012 on the specifications for food additives listed in Annexes II and III to Regulation (EC) No 2 of the European Parliament and of the Council. 1333/2008, provisions laid down.
Paragraph 2. The sentence may rise to prison for two years if the infringement has been carried out with a set of presets or by gross negligence and if there is a breach of the infringement proceedings ;
1) injury to human health or, therefore, hazard, or
2) obtained or intended for the economic benefit of the person concerned itself or others, including in savings.
Paragraph 3. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.
§ 19. With fine penalties, the person violating Article 1 of Commission Regulation (EC) No 1332/2008 of 16. In December 2008 on the food enzymes and amending Council Directive 83 /417/EEC, Council Regulation (EC) No 149/EC (EC) No 145.4. Regulation (EC) No 1493/1999, Directive 2000 /13/EC, Council Directive 2001 /112/EC and Regulation (EC) No 31, The provisions of 258/97 are laid down.
Paragraph 2. The sentence may rise to prison for two years if the infringement has been carried out with a set of presets or by gross negligence and if there is a breach of the infringement proceedings ;
1) injury to human health or, therefore, hazard, or
2) obtained or intended for the economic benefit of the person concerned itself or others, including in savings.
Paragraph 3. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.
Entry into force
20. The announcement shall enter into force on 1. June 2013.
Paragraph 2. At the same time, notice No 1114 of 28. Nov, 2012 on the conditions of life to food.
The FDA, the 27th. May 2013
Esben Eoked Rasmussen
/ Louise Baad Rasmussen
Appendix 1
Extraction measures which may be used for the processing of raw materials, food, food ingredients and food ingredients
Part I
Extraction measures for all purposes and used in compliance with good manufacturing practices 1)
|
1) An extraction shall be deemed to have been applied in compliance with good manufacturing practice, provided that the use of it only results in the presence of residues or of conversion products in technically unavoidable quantities which do not constitute a risk to : human health.
2) The use of acetone by the refining of oil from presses of olives is prohibited.
Part II
Exceptional means of specified end-use
|
1) Hexane is a commodity that is mainly made up of acyclic saturated hydrocarbons containing 6 carbon atoms and distilled between 64 ° C and 70º C. Combined use of hexane and methylethyl ketone is prohibited.
2) The contents of the n-hexane of this extraction shall not exceed 50 mg/kg. This extraction should not be used in conjunction with hexane.
Part III
Exceptional means of specified end-use
|
1) Combined use of these two additional measures shall be prohibited.
Appendix 2
Information to be supplied in the context of the approval of a food enzyme
For the application for approval of a new food enzyme, one of these two models shall be used :
YOU.
Guidance of the Scientific Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids (CEF) on the Submission of a Dossier on Food Enzymes for Safety Evaluation by the Scientific Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids (Question No EFSA-Q 2007-080)
II.
Administrative information
Name of the notifier, producer (s), and the person responsible for the application.
Technical Data
1. Active constituents
1.1 Enzyb's main activities must be described by their systematic names and their Enzyme Commission numbers. 1)
The activity of 1.2 Enzymes is to be measured according to the response to each enzyme catalytic enzymes and should normally be expressed in activity units per unit. the weight or volume unit of the product. The product ' s activity at times is also specified as the quantity of the enzyme product to be added to a given quantity of food in order to achieve the desired effect.
1.3 A list of secondary enzymatic activities, whether they are filling in a useful function or not.
2. Entry Materials
If there is a possibility for specific starting materials that they contain substances which may be harmful to health, the absence of such substances in the enzyme product must be documented (see 8.5).
2.1 Animal Escape Materials.
The species of the species and the part of the animal being used for the manufacture shall be reported. Animal tissue used for enzyme production must comply with the rules on meat-testing and be treated in accordance with good hygienic practices.
2.2 Vegetabils starting materials.
The nature of the plant, as well as which part of the plant used for manufacture, must be reported.
2.3 microbials used in the manufacture of enzyme products may be original or variants of micro-organisms, or may be derived from indigenous tribes or variants with selective cultivation or gene splicing. It must be autonomous and stable tribes or variants, which are sufficiently well described according to generally accepted identification keys, so that they are described uniquely as the dispos; of the enzyme products which are to be used ; described in the specifications.
The microbial culture used in the manufacture must be kept under conditions which ensure the absence of stem cells, and when they are made ready to be used in the production of enzyme products, the methods and cultivation conditions used must ensure uniformity and reproducibility from batch to batch. These procedures shall ensure that the organisers do not produce toxins, and prevent the supply of alien micro-organisms, which could be a source of toxic material and other undesirable substances in the final enzyme products.
2.4 genetically genetically genetically genetically genetically genetically genetically organisms. Specifications shall include characterisation of host-organisms, vector (placards) and the DNA sequence encoded in the vector or chromosomal. The donor organisation must also be identified, whether it is a plant, an animal or a micro-organism.
It is important that there is detailed knowledge of the genetic structures involved, so that any undesirable interplay between the host body of the host body and the new hereditary heritage can be foreseen. Data related to the structure of the inherit mass, such as the presence of additional DNA (plations or foreign DNA added to the host chromosomes), specific genetic characteristics (' marshall `), , the presence of rested genes (which may reflect the presence of mutations), genetic stability (the mutation, inter-and intramolecular recombinations, restriction barriers), re-transfer (capacity for mobilisation / conjugation) and resistance ; (antibiotics, heavy metals) can contribute to predileing health risks for humans, animals and plants, as well as ecological effects.
Exact knowledge of the identity and biology of the vector shall constitute the basis for assessing the extent to which incorporation of the vector increases or reduces the risk of the host micro-organism. Vectors should be described at the DNA level (size, restriction card, and, where possible, completely DNA sequencing) and genetically for the genes that occur on the vector and which would be used as marker genes. Vectors must be free from harmful sequences and be non-conjugent and non-mobiliser.
The DNA sequencing which must be incorporated into host organisms must be fully described in a molecular level and in terms of the number of incorporated genes, regulatory activities (promotor activity) and actual gene products. The accident on the DNA sequencing derived from microorganisms, plants or animals, the exact origins and characteristics of the genetic design must be used so that a proper health assessment can be carried out.
Each recombinant product must be evaluated from case to case in the light of host, vector and the inserted inheriance, taking into account that the possible risk of the final design may be greater than the sum of the individual elements.
3. Manufacturing Method
3.1............... In the field of microbial exit organisms, information on fermentation medium and conditions is considered essential. All the components used must be of food quality.
3.2 The purification method must be adequately informed. If changes are made to the manufacturing method or in the cleaning of the enzyme product, this will be considered new, unless it can be demonstrated that the final product may be considered identical to what was produced after the old methods.
4. Binary substances and other additives and ingredients
4.1 Information on the carrier substances, solvents, formulants and other additives and ingredients (including technical aids) used in the manufacture, distribution and use of the enzyme products must be provided. Substances shall be used which are acceptable in relation to the relevant food applications of the relevant enzyme products, or substances that are insoluble in food, and which are removed from the food after processing or before the recording.
4.2 In the case of immobilized enzyme products, the carrier media and the immobilization of the products should be acceptable in relation to the applicable uses. In the consideration of new materials, these tests should be tested to show that harmful residues are not rendered to the food. tests should be carried out to demonstrate that any charge of immobilisation means or enzymes must be maintained within the acceptable limits set out in each specification.
4.3 To be able to distinguish the part of the enzyme product obtained from the source material from the part used by solvents and other additives and ingredients, the percentage total organic matter (T) may be completely organic. Total Organic Solids (O.) is required. T. O. S. "D" is defined as follows :
% T. O. S. = 100-(A + W + D)
where A =% ash, W =% water and D = solvents and / or other additives and ingredients.
T o. S. can also be expressed in relation to the pure active ingredient (that is, the enzyme team). Depending on the product concerned, the relationship may be very close to 1.
5. Applicable
Information should be provided on :
5.1 The technological function of the enzyme.
5.2 What types of food enzyme are intended to be used in.
5.3 The maximum amount of the enzyme product to be used in each food supply.
6. Stability and fate in food
Information about :
6.1 The amount of the enzyme product (that is, actively enzyme as well as other components) in the finished foodstuff.
6.2 Primary reaction products, as well as possible secondary response products, which are not regarded as normal nutrient components formed during the production and storage of enzyme treated foodstuffs.
6.3 Possible effects on nutrients.
General requirements and specifications
7. Hygiene
7.1 Enzyme products must be produced in accordance with good manufacturing practice for foodstuffs. The STC (s) of micro-organisms used as source material for enzyme products should be tested on a regular basis to ensure their purity (see paragraph 2.3).
7.2 The addition of an enzyme product for a food product shall not result in an increase in the total number of the food product.
8. Pollution
8.1 Tungmetal clay.
The products should not contain toxicologically significant quantities of heavy metals such as lead, cadmium, arsenic and mercury, and the actual heavy metals should be reported for each product.
8.2 Microbiological contaminants.
The use of suitable methods must not be demonstrated by pathogenic micro-organisms (e.g. Campylobacter, Clostridium perfringen, Escherichia coli, Listeria, Salmonella, Shigella) 2) 3) .
Coliform not more than 30 per g, determined by an appropriate method ; 4) .
Total number of non-102-104 per g per g determined by a suitable method 4) .
8.3 The test shall be shown in the case of proof that no viable cells appear from the microbial exit organism in the final product.
8.4 Using a suitable method, an antibiotic activity of the enzyme products must not be allowed to be demonstrated ; 5) .
8.5 Enzym products must not contain toxins in any quantity of iniscurity. When it is known that a given source of material may produce toxins, the absence of the appropriate toxins will be shown by the use of an appropriate method.
Documentation for security by use
9. Basic toxicological requirements
9.1 No toxicological tests are normally required for enzymes extracted from edible parts of animals or plants. If parts are used which are not generally considered to be a normal part of the diet, a certain toxicological test may be required, unless other satisfactory documentation is provided to ensure that the product may be used safely.
9.2 for enzyme products obtained by means of micro-organisms normally require the following tests :
a) 90-day oral toxicitest test in a rodent.
b) 2 short time tests
-WHAT? a test for gene mutations in bacteria ; and
-WHAT? a test for chromosomal abnormations (preferably in-vitro).
The toxicological tests must, where possible, be carried out on a batch of the final, purified fermentation product before the addition of carrier substances, solvents and so on should be carried out in the general rule in accordance with established guidelines (EU/OECD), although it may be necessary to make certain modifications to the standard test protocols, in particular in the case of in-vitro tests, due to the effect of the protein and / or enzymatic activity of certain enzymes products, cellular level. Such deviations will be acceptable if they are accompanied by an adequate arguments to support them.
The test system is designed to uncover unspecified toxic reactions as well as reveal genotoxic effects. The combination of information from the general specifications and the test sets makes it possible to assess the presence in a product of both specific, well-known toxins and unknowable toxic substances.
The toxicological report shall contain satisfactory evidence that the tests carried out have been carried out on the material for the product on the market, as described in the technical part of the application.
10. Exclusions of the basic toxicological requirements
From a toxicological point of view, it is important to carry out a toxicological test procedure on each enzyme product obtained from a microbiological outlet organism.
10.1 If one enzyme product from a particular strain has been temporarily tested, and the manufacturing process is not significant different for other enzymes from the same strain, the enzymes could be ignored for these enzymes from the whole test set. Resolution on this shall be taken from case to case.
10.2 If the micro-organism used for manufacture,
-WHAT? long periods of food have been used without health problems ; and
-WHAT? belong to a species for which it has been documented that toxins are not produced ; and
-WHAT? the strain that is actually used is of well-documented origin, there may be grounds for accepting an enzyme product from this organism without specific toxicological tests.
In that case, a correct and authenticated identification of the organism is particularly important.
For the time being, there can only be one example of such an organism, namely the Cerviomyces cerevisiae of Saccharomyces.
However, the enzyme products from such release organisms shall continue to be in accordance with the general specifications.
10.3 If the original strain of a micro-organism used in the manufacture of a previously tested and approved enzyme product is replaced by a mutant strain, a modified, minor test procedure may be in order. Such a reduced procedure must be justified on a case-case-case basis.
10.4 For immobilized enzyme products, where the immobilization methods are evaluated and approved on the basis of adequate toxicological tests, it is true that these immobilisation methods may be combined with prior evaluated and approved enzyme products ; without the need for further toxicitor tests of the finished product, provided that analytical data is presented showing that the cost of the combined product components is located within acceptable limits (see 4.2).
10.5 The introduction of well-specified, non-toxin-producing gene-producing organisms for the production of food enzyme products, could in future be possible to produce enzymes of very high purity and specificity. For products in which such high purity and specificity are proven, there may not be a need for the whole toxicity test procedure.
In addition to the cases where a reduced test procedure may be acceptable, cf. above, there may also be situations where additional tests are required, in addition to the basic requirements, in order to answer questions raised in some of the basic studies.
Appendix 3
Use of nitrites (E 249-250) to meat products.
On the basis of the Commission's decision No 2010/561 of 25. The national provisions on the addition of nitrite to certain meat products for which Denmark has notified the national provisions on the addition of nitrite to certain meat products for which Denmark has announced are hereby established and limits on the use of nitrites (E 249-250).
The food groups referred to in the table shall correspond to the food groups referred to in Annex II of Regulation (EC) No (EC) of the European Parliament and of the Council. 1333/2008 of 16. In December 2008 on food additives and replaces the uses that are reflected in it.
|
1) A mixture of potassium nitrite or sodium nitrite and sodium chloride means a mixture of potassium nitrite or sodium chloride with a maximum of 1,2% nitrium calculated as sodium nitrite. A mixture of nitrite with potassium nitrate or sodium nitrate is also acceptable.
2) Admitted to the amount calculated as NaNO2 and only in the form of nitrite.
Quantity calculated as NaNO2, and only in the form of nitrite. A mixture of nitrite with nitrate, E 251-252 is also acceptable.
1) The commotion contains provisions which implement the following Directives or parts thereof : Directive 2009 /32/EC of the European Parliament and of the Council of 23. April 2009 on the approximation of the laws of the Member States relating to extraction funds used in the production of food and food ingredients, EU-timid 2009, L 141, p. Directive 3 as amended by the Commission Directive 2010 /59/EC of 26. August 2010, EU-decade 2010, L 225, p. 10. The notice shall refer to : Regulation (EC) No 2 of the European Parliament and of the Council. 1333/2008 of 16. In December 2008 on food additives, EU-timing 2008, L 354, p. Regulation 16, Regulation of the European Parliament and of the Council (EC) 1332/2008 of 16. In December 2008 on the food enzymes and amending Council Directive 83 /417/EEC, Council Regulation (EC) No 149/EC (EC) No 145.4. Regulation (EC) No 1493/1999, Directive 2000 /13/EC, Council Directive 2001 /112/EC and Regulation (EC) No 31, 258/97, EU-tiering 2008, L 354, p. Regulation (EC) No 7 of the European Parliament and of the Council 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 2, Regulation (EC) No 2232/96, Regulation (EC) No 2232/96, 110/2008 and Directive 2000 /13/EC, EU-timing 2008, L 354, p. 34. According to Article 288 of the EDF Treaty, a Regulation shall apply immediately in each Member State. The rendering of and the reference to these provisions in the notice shall be based solely on practical considerations and shall be without prejudice to the immediate validity of the said Regulations in Denmark.
1) Enzyme Nomenclature. International Union of Biomobility and Molecular Biology, Academic Press, Inc. 1992.)
2) FDA Bacteriological Analytical Manual, Sixth Edition (1984).
3) Microbiology-General guidance for enumeration of Coliforms. Colony count technique at 30 ° C. ISO International Standard Ref. No! ISO 4832, First Edition (1978).
4) Microbiology-General guidance for the enumeration of micro-organisms. Colony count technique at 30 ° C. ISO International Standard Ref. No! ISO 4833, First Edition (1978).
5) Compendium of Food Additive Specifications. Food and Agriculture Organization of the United Nations, Rome 1992
