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Royal Decree 1650 / 1991, Of November 8, Which Approves The Reglamentación For The Preparation And Sale Of Juices Of Fruits And Other Similar Products.

Original Language Title: Real Decreto 1650/1991, de 8 de noviembre, por el que se aprueba la reglamentación técnico-sanitaria para la elaboración y venta de zumos de frutas y de otros productos similares.

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TEXT

Royal Decree 667/1983, of March 2, approved the Technical-Health Regulations for the manufacture and sale of fruit juices and other vegetables and their derivatives.

The experience gained in the application of this Regulation and the need to adapt Spanish legislation to that of the European Economic Community, as laid down in Council Directive 75 /726/EEC of 17 November 1975 on the approximation of the laws of the Member States relating to fruit juices and other similar products (Official Journal of the European Communities, number L 311 of 1 December), as amended by the Council Directives 79 /168/EEC of 5 February 1979 (Official Journal of the European Communities, number L 37, 13); 81 /487/EEC of 30 June 1981 (Official Journal of the European Communities, No L 189 of 11 July 1989) and 89 /394/EEC of 14 June 1989 (Official Journal of the European Communities, number L 186 of 30 June), it is necessary to amend that legislation by means of the partial harmonisation of the Community Directives mentioned above, since the reference to grape juice has been harmonised by Royal Decree 1044/1987 of 31 July 1987.

This Royal Decree and the Technical-Health Regulations, which are adopted, except for Article 10 (2) of the Technical-Health Regulations, are given in accordance with the provisions of the 149.1.16.a of the Constitution and in accordance with article 40.2 of Law 14/1986, of April 25, General of Health, except for the regulation of exports and imports, which is covered by Article 149.1.10.a Constitution.

In its virtue, on a proposal from the Ministers of Health and Consumer Affairs, Industry, Commerce and Tourism and Agriculture, Fisheries and Food, prior to the mandatory report of the Inter-Ministerial Commission for Food Management, Ears the sectors concerned, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 8 November 1991,

DISPONGO:

Single item.

The accompanying Technical-Health Regulations for the manufacture and sale of fruit juices and other similar products are approved.

ADDITIONAL DISPOSITION

This Royal Decree and the Technical-Health Regulations, which are approved, except for Article 10 (2) of the Royal Decree, are given in accordance with the provisions of Article 149.1.16.a of the Constitution in how much it attributes to the State the general basis and coordination of health, except as contained in Article 12 of the Regulations, which is issued under Article 149.1.10.a of the Constitution.

TRANSIENT PROVISIONS

First.

Products falling within the scope of this Royal Decree, drawn up prior to the entry into force of this Royal Decree and in accordance with the provisions of Royal Decree 667/1983 and provisions which develop, may continue to be placed on the market until 12 months after the date of entry into force of this Royal Decree.

Second.

The stocks of packaging and labels, in accordance with the provisions of Royal Decree 667/1983 and provisions implementing it, may be used up to a maximum of six months from the date of entry into force of this Royal Decree.

REPEAL PROVISION

It is repealed from the Technical-Health Regulations for the production and sale of fruit juices and other vegetables and their derivatives, approved by Royal Decree 667/1983 of 2 March, all that relates to fruit juices and other similar products covered by the attached Technical-Health Regulations, except for Articles 16, 17 and 18.

Also, as many provisions of equal or lower rank are repealed, they are subject to the provisions of the attached Technical-Health Regulations.

FINAL DISPOSITION

This Royal Decree will enter into force the day after its publication in the "Official State Gazette".

Given in Madrid to November 8, 1991.

JOHN CARLOS R.

The Minister of Relations with the Courts and the Government Secretariat,

VIRGILIO ZAPATERO GOMEZ

TECHNICAL-HEALTH REGULATIONS FOR THE MANUFACTURE AND SALE OF FRUIT JUICES AND OTHER SIMILAR PRODUCTS

PRELIMINARY TITLE

Object and Scope

Article 1. º

The purpose of this Regulation is to define, for legal purposes, what is meant by fruit juices and similar products, and to lay down the rules for the production, marketing and, in general, the legal order of such products.

Your regulations apply to all the working conditions that meet the definitions included in the title of this Regulation, except for:

To grape juices regulated by Royal Decree 1044/1987 of 31 July.

To products from tomato and coconut.

To dietetic products.

To products destined for export outside the European Economic Community.

This Regulation obliges all manufacturers, traders and importers of fruit juices and other similar products.

TITLE FIRST

Definitions and denominations

Art. 2. º

For the purposes of this Regulation,

following definitions shall apply:

2.1 Fruit Zumo.

2.1.1 It is understood by juice or fruit juice, obtained from fruit by mechanical procedures, susceptible to fermentation but not fermented, which possesses the colour, aroma and taste characteristic of the juices of the fruits that it comes from.

In the case of citrus fruits, fruit juice comes from the endocarp, however, the lime juice may be obtained from the whole fruit according to good manufacturing practices which must be able to minimize the presence in the juice of constituents of the outer parts of the fruit.

2.1.2 For fruit juice, or juice, the product obtained from concentrated fruit juices shall also be understood as:

(a) restoring the proportion of water extracted to the juice in the concentration process; the water to be added must present appropriate characteristics, in particular from the chemical, microbiological and organoleptic so that the essential qualities of the juice are guaranteed and

b) restoring its aroma by means of flavouring substances recovered by concentrating the fruit juice in question or the fruit juice of the same species.

And which has organoleptic and analytical characteristics equivalent to those of the juice obtained in accordance with the provisions of paragraph 2.1.1 from fruit of the same species.

2.2 Zumo of concentrated fruit. -It is the product obtained from fruit juices, by elimination, by physical procedures of a part of its water of constitution. When the product is intended for direct consumption, the concentration shall be at least 50 per 100.

2.3 Zumo of dehydrated fruit.-The product obtained from fruit juice by means of physical procedures eliminating almost all of the water that constitutes it.

2.4 Pure or pulp or cremogenate of fruit. -It is the product susceptible of fermentation but not fermented obtained by milling or sifting, of the edible part of fruits, whole or peeled without removing the juice.

2.5 Pure or pulp or cremogenate of concentrated fruit.-The product obtained from the puree, the pulp or the cremogenate of fruit by means of physical procedures, eliminating part of the water that constitutes it.

2.6 Nectar of fruit.-The unfermented but susceptible product of fermentation, obtained by adding water and sugars to the fruit juice; to the concentrated fruit juice; to the puree, the pulp or the cremogenate of fruit; to the puree, the pulp or the cremogenate of concentrated fruit; or a mixture of these products and which complies with the specifications set out in the Annex to this Regulation.

Art. 3. º

The products defined in paragraphs 2.1, 2.2, 2.3 and 2.6 and in Article 2 may be placed on the market only if they comply with the rules laid down in this Technical-Health Regulation and in the Annex thereto.

Art. 4. º

Articles 6, 7, 7, 8, 8 and 11, other than paragraph 11.2, shall apply only to fruit juices, concentrated fruit juices, sugar juices, gasified juices, dehydrated juices, to the mixture of juices fruit intended for direct consumption, concentrated fruit juices used for the manufacture of juices or nectars intended for direct consumption, as well as fruit juices used for the manufacture of fruit nectars intended for use in the direct consumption.

Art. 5. º

The designations set out in paragraphs 2.1, 2.2, 2.3 and 2.6 of Article 2 are reserved for the products that these paragraphs define, and should be used in trade to designate them.

TITLE II

Permitted and prohibited manipulations

Art. 6. º

Fruit juices, concentrated fruit juices and dehydrated fruit juices.

6.1 Only authorized for the manufacture of fruit juices:

6.1.1 The mixture of one or more species of fruit juices and/or fruit puree, as defined in paragraphs 2.1 and 2.4 of Article

.

6.1.2 Treatment by the following substances:

L-ascorbic acid (E 300) at the dose necessary for it to have an antioxidant effect; nitrogen; carbonic anhydride (E 290); proteolytic enzymes; pectolytic enzymes; amylolytic enzymes; food gelatin; tannin; bentonite; Silicon gel; kaolin; carbons; inert filtration additives (washed diatomite, cellulose, insoluble polyamide).

6.1.3 The usual procedures and treatments, such as thermal treatments, centrifugation and filtration.

6.2 In addition, they are authorised for the manufacture of fruit juices:

6.2.1 Addition to pineapple juices, citric acid (E 330) in an amount not exceeding 3 grams per litre.

6.2.2 For non-pear juices, authorised sugars may be added to them, under the following conditions:

(a) in an amount expressed in dry matter not exceeding 15 grams per litre of juice, for correction;

(b) in an amount expressed in dry matter not exceeding:

40 grams per litre of juice in the case of apple juice; 200 grams per litre of juice in the case of lemon juice, lime juice, bergamot juice, and red currants, white currants and blackcurrants; 100 grams per litre of juice in other cases in order to obtain a sugar flavour.

6.2.3 The addition of more than one acid to the same fruit juice, provided that the sum of the added amounts of each of them, expressed as a percentage of the maximum authorized quantity, does not exceed 100.

6.2.4 The presence of sulphur dioxide in juices up to a maximum of 10 mg/l.

6.2.5 Enrichment in vitamins. Where the amount of vitamin C added does not exceed the maximum quantity authorised as an antioxidant, it shall be referred to as 'L-ascorbic acid' only.

Only mention of its vitamin C content shall be made in both the list of ingredients and in other inscriptions, when guaranteed in the product and up to the date of minimum duration, a minimum of vitamin C of 400 mg/l, in where the product will be considered rich.

Of any other vitamin added to the product, no mention should be made as long as it does not contain the minimum amount to be determined by the legislation on enriched foods.

6.2.6 The diffusion processes for the manufacture of fruit juices other than citrus fruit, pineapples, pears, peaches and apricots intended for the manufacture of concentrated fruit juices, provided that the fruit juices concentrated thus obtained are in accordance with the definition in Article 2 (2.1) of this Regulation in respect of fruit juices obtained from concentrated fruit juices, and have organoleptic characteristics and at least equivalent to those of concentrated juices obtained by means of use mechanical means.

6.2.7 In accordance with the provisions of the Resolution of 21 April 1983, of the Health and Consumer Affairs Secretariat, the positive list of additives and processing aids for use in the preparation of Fruit juices and other vegetables and their derivatives (Official State Gazette of 15 July) may be added to the additives listed in this list:

6.2.7.1 To the pineapple, apple, orange and grapefruit juices, the following substances, under conditions that the total amount added, expressed in sulphur dioxide, does not exceed 50 ppm:

Sulphur dioxide (E 220), sodium sulphite (E 221), sodium sulphite (sodium bisulphite) (E 222), sodium disulfite (sodium pyrosulphite or sodium metabisulfite) (E 223), potassium disulfite (potassium pirosulfite or potassium metabisulfite) (E 224), calcium sulphite (E 226), calcium acid sulphite (calcium bisulphite) (E 227).

The substances mentioned above may also be added to lemon and lime juices, provided that the total amount added, expressed in sulphur dioxide, does not exceed 350 ppm.

6.2.7.2 To pineapple juices, dimethylpolysiloxane, provided that the total amount added does not exceed 10 ppm.

6.2.7.3 To apple juices, citric acid (E 330), provided that the total amount added does not exceed 3,000 ppm.

6.2.7.4 To pineapple juices, L. malic and DL acids. malic, together or separately, provided that the total amount added does not exceed 3,000 ppm.

6.3 The addition of sugars and acid to the same fruit juice is prohibited.

6.4 Only allowed for the manufacture of concentrated fruit juices:

6.4.1 The treatments and procedures listed in this article, except for paragraph 6.2.2. However, the addition of sugars provided for in that paragraph shall be authorised only in the case of pre-packaged concentrated fruit juices intended for the final consumer and provided that the addition of sugar is indicated in the name; in that case, the total number of added sugars expressed in relation to the volume of juice, once reconstituted, shall not exceed the limits allowed in that paragraph.

For a period of 10 years from the date of entry into force of this Royal Decree, sugars may be added to the concentrated orange juice not intended for the final consumer by a maximum quantity expressed in respect of dry of 15 grams per litre for correction.

In the case referred to in the preceding paragraph, the addition of sugars shall be made known to the processor, in accordance with commercial uses.

6.4.2 Partial dehydration of fruit juice by means of a treatment or physical process with no direct fire.

6.4.3 The refund of flavourings by means of aromatic substances recovered at the concentration of the fruit juice or fruit juice of the same species; this addition shall be compulsory for fruit juices concentrates intended for direct consumption.

6.5 For the manufacture of dried fruit juices, almost all of the fruit juice is allowed to be dehydrated by means of a physical process or treatment, excluding direct fire, with the return of the fruit being compulsory. essential aromatic components from the same species of fruit or eventually recovered during dehydration.

Art. 7. º

Fruit Nectars.

7.1. Only authorised for the manufacture of fruit nectars:

7.1.1 The mixture between them of fruit nectars of one or more species, being able to add juice or fruit puree.

7.1.2 The treatments and procedures listed in paragraphs 6.1.2 and 6.1.3 of Article

.

7.1.3 In addition they will be authorized:

(a) The addition of sugars as long as it does not exceed 20 per 100 by mass in relation to the total mass of the finished product;

(b) The addition of water in such quantity that the juice and/or fruit puree content and the total acidity of the finished product are not less than the percentages set out in the Annex; in the case of a mixture, the juice and/or puree content, as well as the total acidity, they shall be proportionally in accordance with the percentages set out in the Annex;

(c) Total replacement of the sugars by honey with respect to the limit of 20 per 100 fixed in point (a)

(d) For the manufacture of fruit nectars referred to in Article 11 (2) (c), where they are obtained from apples, pears or peaches or from a mixture of those fruits, the addition of citric acid in quantity not exceeding 5 grams per litre of finished product; however, citric acid may be replaced in whole or in part by an equivalent quantity of lemon juice;

e) The addition of more than one acid to the same fruit nectar, provided that the sum of the added amounts of each of them, expressed as a percentage of maximum authorized quantity, does not exceed 100.

7.2 In addition, it is authorized for the manufacture of fruit nectars:

7.2.1 Enrichment in vitamins.

7.2.2 In accordance with the provisions of the Resolution of 21 April 1983, of the Health and Consumer Affairs Secretariat, the positive list of additives and processing aids for use in the production of Fruit juices and other vegetables and their derivatives (Official State Gazette of 15 July) may be added to the additives listed in this list: L-malic and DL-malic acids, together or separately, to the nectars of pears or peaches obtained, exclusively, from fruit puree, if not concentrated, provided that the total amount added does not exceed 3,000 ppm.

Art. 8. º

The procedures and treatments provided for in Articles 6 and 7 of this Regulation shall ensure that no quantity of substances which can be represented in the treated products remains a danger to human health.

TITLE III

Raw materials and other ingredients

Art. 9. º

Fruit juices and other similar products may be made with the following ingredients:

9.1 Fruit: The fruit, fresh or preserved by the cold, healthy, devoid of alteration, with all its essential components for the manufacture of fruit juices or nectars in the appropriate degree of maturity.

9.2 Drinking water: The water used in the preparation of the products covered by this Regulation must meet the physical, chemical and microbiological conditions indicated in the current Technical-Health Regulations for the supply and quality control of drinking water for public consumption, approved by Royal Decree 1138/1990 of 14 September 1990.

9.3 Sugars:

9.3.1 For the manufacture of fruit juices:

Semi-white sugar, sugar (white sugar), refined sugar (refined white sugar), dextrose monohydrate, dextrose anhydrous, dehydrated glucose syrup and fructose.

9.3.2 For the manufacture of fruit nectars, as well as for reconstituted fruit juices, in addition to the sugars referred to in paragraph 9.3.1:

Glucose syrup, the liquid sugar, the glucose liquid sugar, the glucose syrup and the aqueous solution of sucrose, which responds to the following characteristics:

Dry matter, exceeding 62 per 100 by mass; amount of invert sugar (fructosa/dextrose ratio), less than 0,3 per 100 in -mass on dry matter; conductive ash, less than 0,3 per 100 mass on matter dry; solution colour not exceeding 75 ICUMSA units, and SO2 residual, maximum of 15 mg/kg on dry matter.

9.3.3 The sugars specified above will comply with the existing Specific Regulations.

TITLE IV

Packaging and Labelling

Art. 10. Packaging.

10.1 Products subject to this Regulation shall always be sold in containers made of materials authorised to be in contact with food, which shall, as appropriate, comply with the provisions of the Royal Decree 1125/1982 of 30 April 1982 approving the Technical and Health Regulations for the elaboration, circulation and trade of polymeric materials in relation to foodstuffs and foodstuffs, as amended by the Royal Decree 68/1990 of 25 May 1990, in Royal Decree 1425/1988 of 25 November 1988 on the Technical-health regulations for the production, circulation and trade of plastic materials intended to be in contact with food and food products, and in Royal Decree 397/1990 of 16 March, approving the general conditions of the materials, for food use, other than the polymeric materials.

10.2 The nominal quantities of the packaging of the products covered by this Regulation intended for the final consumer shall be in accordance with point 9 of Annex I to Royal Decree 1472/1989 of 1 December 1989. the ranges of nominal quantities and nominal capacities are regulated for certain packaged products.

Art. 11. Tagged.

The labelling of packages of fruit juices and other similar products, intended for the final consumer, restaurants, hospitals and other similar establishments and collectivities, will be governed by the provisions of the Royal Decree 1122/1988 of 23 September 1988 approving the general rule for the labelling, presentation and advertising of packaged foodstuffs.

Specifically, they will:

11.1 Product Sales Denomination.

11.1.1 It shall be that provided for in the definitions and designations referred to in the first Title of this Technical-Health Regulation.

11.1.2 When the product comes from a single species of fruit, the indication of the fruit will replace the word "fruit" or accompany the names not bearing the word "fruit".

11.1.3 Dehydrate may be replaced in the dried fruit juices by the words "powder" or replaced or accompanied by the indication of the specific treatment used (such as: lyophilisate or any other analogous mention).

11.1.4 The sales name must be completed:

(a) In the case of mixtures of two or more fruits, the name shall be supplemented by the enumeration of the fruit containing the product, by quoting them in descending order according to the weight of the fruit juices or fruit purées used, the case, after reconstitution. The detailed fruit ratio may be replaced by the generic name 'fruits'.

In the case where lemon juice is used in pear, apple, peach or its mixtures in lower quantities, in acidity equivalent in the finished product, at 5 grams per litre of citric acid, the lemon juice does not must appear in the product name.

(b) The labelling of products which have added sugar to them within the limits laid down in paragraph 6.2.2 (b), the words "sugary", followed by the indication of the maximum quantities of added sugars, calculated in dry matter and expressed in grams per litre. The quantity indicated may not exceed more than 15 per 100 to the amount actually added.

(c) For fruit nectars referred to in paragraph 11.2 (c) of this Article, which are not designated exclusively with the name "Swedish and polpa", with the words "contains fruit pulp" or a reference equivalent.

11.1.5 The products defined in paragraphs 2.1, 2.2, 2.3 and 2.6 of Article 2. must include the following particulars:

(a) For fruit juices and nectars obtained in whole or in part from a concentrated product, the words "based on ... concentrated", supplemented by the indication of the concentrated product used; this indication must appear next to the product name, so that it is highlighted with the relationship to all context, and in well-visible characters.

(b) In fruit juices, concentrated fruit juices and nectars whose CO2content is greater than 2 grams/litre, the expression "gasified" or "with gas" shall appear.

c) For concentrated fruit juice and dehydrated fruit juice, the amount of water to be added to reconstitute the product.

d) For fruit nectar, the indication of the actual minimum content of fruit juice, fruit puree or mixture of the above, with the words "fruit content ...... per 100 minimum".

11.2 The following denominations are reserved:

a) "Vruchtendrank", for fruit nectars;

(b) "Sussmost" for fruit nectars obtained exclusively from fruit juices, concentrated fruit juices or a mixture of these two products, not edible under these conditions due to their high acidity natural;

c) "Swedish and polpa" for fruit nectars obtained exclusively from fruit purées eventually concentrated.

d) "Aeblemost" to apple juices without addition of sugars.

(e) "South ...... saft", supplemented by the Danish indication of the fruit used, to juices without the addition of sugars obtained from blackcurrants, cherries, red currants, white currants, raspberries, strawberries or Sauto grains.

However, the use of the name "fruit nectar" shall be optional for the products described in (a), (b) and (c).

11.3 List of Ingredients:

It will be mandatory to include the list of ingredients, with the following exceptions:

a) Reconstitution in its original state and by means of the substances strictly necessary to perform this operation:

Fruit juice from concentrated fruit juice;

From fruit puree from concentrated fruit puree.

b) The refund of the aroma:

To concentrate fruit juice,

Dehydrated fruit juice,

No obligation to include the list of ingredients used for that purpose.

(c) Additives: Sulfide anhydride (E 220), sodium sulphite (E 221), sodium sulphite (E 222), sodium disulfite (E 223), potassium disulfite (E 224), calcium sulphite (E 226) and calcium acid sulphite (E 227), shall be considered as ingredients in any of the products defined, where the sulphur dioxide content of such products, determined by the corresponding analysis, is not more than 10 mg. per litre.

11.4 The particulars referred to in points (a), (b) and (d) of paragraph 11.1.5 shall appear in the same visual field as the sales denomination of the product, the net content and the date of minimum durability.

11.5 The addition of L-ascorbic acid in the terms of paragraph 6.1.2 of Article 6 does not authorize any reference to vitamin C.

11.6 The products covered by this Regulation, which are not intended to be delivered as such to the final consumer and contained in containers of a nominal capacity of more than two litres, shall comply with the labelling requirements set out in this article. However, those requirements may be included in the accompanying documents, except the name of sale of the product and the identification of the undertaking, which shall appear on the packaging, provided that the packaging containing them can be clearly identified by such documents.

When the transport is carried out in tanks or containers, these requirements shall be contained in the documents accompanying them.

Art. 12. Export and import.

12.1 The products covered by this Regulation which are to be drawn up for export to non-EEC countries and do not comply with the provisions of this provision shall be printed on their packaging. word "export". In addition, your entiquette must bear the word "export", or any other sign that is regulated and that allows you to identify it unequivocally to prevent the product from being marketed and consumed in Spain.

12.2 Imported products from countries outside the European Economic Community must meet the requirements set out in this provision.

TITLE V

Sampling and analytical methods

Art. 13.

The methods of analysis to be used will be those approved in the Order of the Ministry of Relations with the Courts and the Government Secretariat of 29 January 1988, for which the official methods of analysis of juices are approved. of fruit and other vegetables and their derivatives (Official State Gazette of 5 February 1988).

In cases where there are no official methods for certain analyses and, until such time, they are not approved by the competent body and previously informed by the Inter-Ministerial Committee for Food Management, approved by the national and international bodies of recognised solvency may be used.

The proposing ministers are authorised to issue or amend the official methods of sampling and the official methods of analysis relating to them, by way of order, after a mandatory report from the Commission Interministerial for Food and Food Management, when required for reasons of a health, technological or appropriate nature to the rules of the European Economic Community.

TITLE VI

Responsibilities and sanctioning regime

Art. 14.

The responsibilities as well as the penalties to be imposed for the offences committed will be subject to the provisions of Royal Decree 1945/1983 of 22 June for the regulation of infringements and penalties in respect of consumer protection and agri-food production.

ANNEX

Particular provisions applicable to fruit nectars

30

40

40

40

40

3 (1)

-

45

Nectars

Minimum acidity expressed in grams of tartaric acid per liter of finished product

Minimum juice content and eventually puree expressed as a percentage of the weight of the finished product

1. Non-consumable acid juice fruits in a natural state:

of passion (Passiflora edulis)

8

25

Quito herb (Solanum Quitoense)

5

25

25

8

8

25

Grosellas

8

Uva Spina

9

30

9

25

Endrins

8

30

trails

6

30

wildcat

6

30

Serbal Grains

8

30

Agavances (Rose Fruits sp.)

8

40

bitter cherries (Griots)

8

35

40

4

40

7

50

raspberries

7

40

40

Fresas

6

6

40

40

9

9

30

Memberships

7

50

Limons and limes

-

25

Other fruits belonging to this category

-

25

II. Low-acid or high-pulp or highly flavoured fruits with non-consumable juice in a natural state:

35

Platanos

25

-

25

Papayas

Lichis

-

Acerolas

-

25

Guanabana (Annona Muricata)

-

25

Heart of Buey or Cachiman (Annona Reticulara)

-

Chirimoyâs

Granadas

-

25

-

25

25

25

Caja (Purpurea Spondays)

-

Imbu (Tuberous Aroda Spondays)

-

30

Other fruits belonging to this category

-

25

III. Edible juice fruits in natural state:

Apples

(1)

3 (1)

50

Melocotons

Agrios, except lemons and limes

5

50

Piñas

4

50

Other fruits belonging to this category

50

(1) Limit not applicable in the case of the product referred to in Article 11 (2) (c).