Decree No. 253 / 2018 Coll.
Decree on requirements for extraction solvents used in the manufacture of foodstuffs
Valid
Effective from 09.11.2018
253
DECLARATION
of 30 October 2018
on requirements for extraction solvents used in the manufacture of foodstuffs
The Ministry of Agriculture provides pursuant to Article 18 (1) (c) of Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended by Act No. 306 / 2000 Coll., Act No. 316 / 2004 Coll., Act No. 139 / 2014 Coll., Act No. 180 / 2016 Coll. and Act No. 302 / 2017 Coll.:
Subject matter
(1) This decree implements the relevant provisions of the European Union1) and regulates the quantities and types of extraction solvents, their conditions of use in the manufacture of food and food and food groups in which these substances may occur.
(2) This Decree does not apply to extraction solvents used in the manufacture of food additives including vitamins and minerals intended for use as food additives and food supplements including vitamins and minerals as food supplements, unless those food additives, vitamins and other food supplements are listed in the Annex to this Decree.
Definition of certain terms
For the purposes of this decree:
(a) an extraction solvent of a substance used for the dissolution of foodstuffs or their components, including any contaminants occurring in or on foods, used in the extraction process during the processing of raw materials, foodstuffs or their components and which is removed may, however, lead to an unintended but technically unavoidable presence of residues or derivatives in or in food ingredients;
(b) a hexane commercial product consisting predominantly of acyclic saturated hydrocarbons containing six carbon atoms and which is distilled between 64 ° C and 70 ° C,
(c) gelatine natural soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and ligaments of animals,
(d) collagen protein product from bones, hides, skins and tendons of animals,
(e) the proper manufacturing practice of such use of an extraction solvent which only results in residues or derivatives in a technically unavoidable quantity which is not dangerous to human health.
Extraction solvents
(1) Extraction solvents authorised in the manufacture of foodstuffs, their conditions of use and maximum residue levels of these extraction solvents in the food are set out in Tables 1 and 2 of the Annex to this Decree.
(2) Furthermore, extraction solvents may be used in the manufacture of foodstuffs in accordance with good manufacturing practice
(a) propane,
(b) butane,
(c) ethyl acetate,
(d) ethanol;
(e) carbon dioxide;
(f) acetone with the exception of the refining of olive pomace oil; and
(g) nitrous oxide.
(3) Water may also be used as an extraction solvent, which may contain acidity or alkalinity regulators, as well as food having the characteristics of extraction solvents.
(4) The extraction solvents used in the manufacture of food additives, vitamins and other food supplements must not exceed the maximum residue levels set out in Table 1 or 2 of the Annex to this Regulation.
(5) Extraction solvents must not contain:
(a) the toxicologically hazardous quantity of any element or substance; or
(b) more than 1 mg / kg of arsenic or more than 1 mg / kg of lead, except as provided for in Tables 1 and 2 of the Annex to this Decree.
(6) Extraction solvents shall meet the specific purity criteria set out in Table 3 of the Annex to this Regulation.
Labelling
(1) The packaging, container or label of the extraction solvent shall be clearly, clearly, indelibly and clearly indicated when placed on the market.
(a) the trade description referred to in Section 3 (2), Table 1 of the Annex to this Order or Table 2 of the Annex to this Order;
(b) the name or business name, where applicable, and the address of the registered office of the manufacturer, importer, seller or packer, or the name and surname of the firm, where applicable, and the address of the place of permanent residence or, where applicable, the registered office of the manufacturer, importer, seller or packer,
(c) the words "for food,"
(d) an indication to identify the lot;
(e) an indication of the net quantity in volume units; and
(f) conditions of storage and use where necessary.
(2) The particulars referred to in paragraph 1 (c) to (f) may be given for each lot only in the accompanying documentation, which shall be submitted together with the consignment or in advance.
Transitional provision
Extraction solvents and foodstuffs containing, produced or placed on the market before the date of entry into force of this Decree shall be assessed in accordance with Decree No. 4 / 2008 Coll., as effective before the date of entry into force of this Order, and may be sold until stocks are exhausted.
Repeal
They shall be deleted:
1. Decree No. 4 / 2008 Coll.
2. Decree No. 130 / 2010 Coll., amending Decree No. 4 / 2008 Coll., laying down the types and conditions of use of additives and extraction solvents in food production.
3. Decree No. 122 / 2011 Coll., amending Decree No. 4 / 2008 Coll., laying down the types and conditions of use of additives and extraction solvents in food production, as amended by Decree No. 130 / 2010 Coll.
Efficacy
This Decision shall enter into force on 9 November 2018.
Minister:
Ing. Toman, CSc., v. r.
Annex to Decree No 253 / 2018 Coll.
Extract solvents authorised in the manufacture of foodstuffs for which conditions of use are established, maximum residue levels of extraction solvents in the food and specific purity criteria for extraction solvents
Table 1
| Název látky | Podmínky použití | Nejvyšší povolené množství reziduí rozpouštědla v extrahované potravině |
|---|---|---|
| Výroba nebo frakcionace tuků a olejů a výroba kakaového másla | 1 mg/kg v tuku, oleji nebo kakaovém másle | |
| Výroba či frakcionace bílkovinných produktů a odtučněných mlýnských výrobků | 10 mg/kg v bílkovinném produktu či mlýnském výrobku | |
| 30 mg/kg v odtučněném sójovém produktu při prodeji konečnému | ||
| Výroba odtučněných obilných klíčků | 5 mg/kg v odtučněných obilných klíčcích | |
| Octan methylnatý | Výroba kávy a čaje bez kofeinu nebo se sníženým obsahem kofeinu nebo odstraňování senzoricky nežádoucích látek a hořčin z těchto produktů | 20 mg/kg v kávě nebo čaji |
| Výroba cukru z melasy | 1 mg/kg v cukru | |
| Ethylmethyl-keton | Frakcionace tuků a olejů | 5 mg/kg v tuku nebo oleji |
| Výroba kávy a čaje bez kofeinu nebo se sníženým obsahem kofeinu nebo odstraňování senzoricky nežádoucích látek a hořčin z těchto produktů | 20 mg/kg v kávě nebo čaji | |
| Dichlormethan | Výroba kávy a čaje bez kofeinu nebo se sníženým obsahem kofeinu nebo odstraňování senzoricky nežádoucích látek a hořčin z těchto produktů | 2 mg/kg v pražené kávě a 5 mg/kg v čaji |
| Methanol | 10 mg/kg v potravině | |
| Propan-2-ol | 10 mg/kg v potravině | |
| Dimethylether | Výroba odtučněných bílkovinných potravin živočišného původu včetně | 0,009 mg/kg v odtučněné bílkovinné potravině (včetně |
| Příprava | 3 mg/kg v | |
| 2-methyloxolan | Výroba nebo frakcionace tuků a olejů a výroba kakaového másla. | 1 mg/kg v tuku nebo oleji nebo kakaovém másle |
| Příprava odtučněných bílkovinných potravin a odtučněné mouky. | 10 mg/kg v potravině obsahující odtučněné bílkovinné potraviny a odtučněnou mouku | |
| 30 mg/kg v odtučněné sójové potravině, jak je prodávána konečnému | ||
| Výroba odtučněných obilných klíčků. | 5 mg/kg v odtučněných obilných klíčcích |
Notes:
The combined use of hexane and ethylmethylketone is prohibited.
The permitted amount of n- hexane in the Dimethylether solvent shall not exceed 50 mg / kg.
Table 2
| Název látky | Nejvyšší povolené množství reziduí rozpouštědla v potravině při použití extrakčních rozpouštědel při přípravě látek určených k aromatizaci z přírodních aromatických surovin |
|---|---|
| Diethylether | 2 mg/kg |
| 1 mg/kg | |
| Octan methylnatý | 1 mg/kg |
| Butan-1-ol | 1 mg/kg |
| Butan-2-ol | 1 mg/kg |
| Ethylmethylketon | 1 mg/kg |
| Dichlormethan | 0,02 mg/kg |
| 1,1,1,2-tetrafluorethan | 0,02 mg/kg |
| Propan-1-ol | 1 mg/kg |
| Cyklohexan | 1 mg/kg |
| Methanol | 1,5 mg/kg |
| Propan-2-ol | 1 mg/kg |
| 2-methyloxolan | 1 mg/kg |
Note:
The combined use of hexane and ethylmethylketone is prohibited.
Table 3
| Název látky (IUPAC) | Číslo CAS | Obsah látky v sušině | Požadavky na čistotu | |
|---|---|---|---|---|
| Chemická sloučenina | Povolené množství v sušině | |||
| 2-methyloxolan | 96-47-9 | nejméně 99,9 % | Furan | nejvýše 50 mg/kg |
| 2-methylfuran | nejvýše 500 mg/kg | |||
| Ethanol | nejvýše 450 mg/kg | |||
1) 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 solvents used in the manufacture of foodstuffs and food ingredients. Commission Directive 2010 / 59 / EU of 26 August 2010 amending Directive 2009 / 32 / EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to extraction solvents used in the manufacture of foodstuffs and food ingredients. Commission Directive (EU) 2016 / 1855 of 19 October 2016 amending Directive 2009 / 32 / EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to extraction solvents used in the manufacture of foodstuffs and food ingredients. Commission Directive (EU) 2016 / 797 of 26 January 2016 amending Directive 2009 / 32 / EC of the European Parliament and of the Council as regards 2-methyloxolane.
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Regulation Information
| Citation | Decree No 253 / 2018 Coll., on requirements for extraction solvents used in the manufacture of foodstuffs |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 07.11.2018 |
|---|---|
| Effective from | 09.11.2018 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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