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Royal Decree 2816/1983 of 13 October adopted the Technical-Health Regulations for the elaboration, circulation and trade of detergents.

In view of the fact that the products covered by it have suffered, in recent years, significant innovations, technical and commercial and, in addition, the entry into force of Royal Decree 1078/1993 of 2 July 1993 approving the the Regulation on the classification, packaging and labelling of dangerous preparations, and the approval of Royal Decree 363/1995 of 10 March 1995 on the Regulation on the notification of new substances and classification, packaging and labelling of dangerous substances, it is necessary to carry out an update of the same.

It has been considered appropriate to extend the scope of the technical-health regulation to other products whose manufacture, marketing and applications are similar to detergents.

Also, special formulation and labeling requirements are established for certain liquid dishwashers in order to improve their safety.

The recommendation of the European Commission of 13 September 1989 on the labelling of detergents and cleaning products (89/542/EEC) is also complied with.

This Royal Decree is dictated by the provisions of Article 149.1.10., 16. and 23. of the Constitution and in accordance with Article 40 (2) and (4) of Law 14/1986 of 25 April, General of Health, and the Articles 3.3 and 9.1 of Law 21/1992 of 16 July 1992 on Industry.

All this without the provisions of this Royal Decree being an obstacle to the provisions of Articles 30 and 36 of the Treaty establishing the European Community, nor to the obligations arising from other Treaties or Conventions

This provision has been submitted to the procedure for information on technical standards and regulations laid down in Directive 83 /189/EEC of 28 March 1995 and Royal Decree 1168/1995 of 7 July 1995.

In the proceedings of this Royal Decree the relevant reports of the Council of Consumers and Users and the rest of the affected sectors have been obtained and the Inter-Ministerial Commission for the Ordination has been informed Food.

In its virtue, on the proposal of the Ministers of Health and Consumer Affairs, of Economy and Finance and of Industry and Energy, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting of May 7, 1999,

DISPONGO:

Single item. Approval of the technical-health regulation.

The attached Technical-Health Regulations for the elaboration, circulation and trade of detergents and cleaners are approved.

Single additional disposition. Competence title.

This Royal Decree has the status of a basic rule within the meaning of Article 149.1.10., 16. and 23. of the Constitution and in accordance with Article 40 (2) and (4) of Law 14/1986 of 25 April, General

article 3 (1) of the Law of the European Parliament and of the Council of the European Parliament

First transient disposition. General marketing extension.

In order to enable industries to take the necessary measures to comply with the provisions of this Regulation, all the products concerned may continue to be placed on the market under the conditions laid down in this Regulation. by the previous legislation in force, for a period of eighteen months, counted from the entry into force of this Royal Decree.

Second transient disposition. Extension of the marketing of liquid dishwashers.

However, the requirements laid down in Article 8 (1) and Article 11 (5) for liquid dishwashers shall apply within 12 months of the entry into force of this provision.

Single repeal provision. Unique regulatory repeal.

Royal Decree 2816/1983, dated 13 October, is hereby repealed and approved by the Technical-Health Regulations for the manufacture, circulation and trade of detergents (synthetic detergents and washing soaps).

Final disposition first. Faculty of development.

The Minister for Health and Consumer Affairs and the Minister for Industry and Energy are empowered to dictate the rules necessary for updating the technical annexes to the Regulations to be adopted in the field of their competences. by means of this Royal Decree.

Final disposition second. Entry into force.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Dado en Madrid a 7 de mayo de 1999.

JOHN CARLOS R.

The First Vice President of the Government and Minister of the Presidency,

FRANCISCO ALVEZ-HELMETS FERNANDEZ

TECHNICAL-HEALTH REGULATIONS FOR THE MANUFACTURE, CIRCULATION AND TRADE OF DETERGENTS AND CLEANERS

PRELIMINARY TITLE

Article 1. Scope of application.

The purpose of this Regulation is to determine the technical and health conditions to be met by detergents and cleaners and the requirements to be met by the facilities in which they are prepared and stored. as their transport and sale.

The following products are excluded from the scope of this Regulation:

(a) The remoteness regulated by Royal Decree 3360/1983 of 30 November 1983 and its subsequent amendments.

(b) Pesticides, regulated by Royal Decree 3349/1983 of 30 November, and subsequent amendments thereto.

c) Paintings, varnishes and lacquers.

d) The solvents of paints, varnishes and related products.

e) Queues and adhesives.

This Regulation applies without prejudice to the provisions of Royal Decree 363/1995 of 10 March 1995 approving the Regulation on the notification of new substances and the classification, packaging and labelling of substances (ii) dangerous preparations, and Royal Decree No 1078/1993 of 2 July 1993 adopting the Regulation on the classification, packaging and labelling of dangerous preparations. The products covered by this Regulation must also comply with Royal Decree 1406/1989 of 10 November 1989 imposing restrictions on the marketing and use of certain dangerous substances and preparations, as well as on provisions on biocidal products, in those products where it is applicable.

TITLE I

Definitions, denominations, and classification

Article 2. Definitions and naming.

For the purposes of this Regulation it is understood that:

1. Detergent: it is every product whose composition has been specially studied in order to contribute to the development of the phenomena of determination and which is based on essential components (surfactants) and, generally, complementary components (adjuvants, reinforcing agents, loads, additives and other accessories).

This group includes products whose main purpose is washing, such as those for dishwashing, washing clothes, washing surfaces, and all other surfactants that may have another. complementary purpose, such as those with disinfectant action.

2. Cleaner: the main purpose is the cleaning and maintenance of objects and surfaces such as floors, woods, plastics, tiles, crystals, toilets, metals, fabrics or hides. These products may contain, inter alia, solvents, alkalis, acids, waxes, additives and other auxiliaries. Products intended to purify or aromatize the environment and cleaners also used as a disinfectant are also included.

3. Surfactant: it is any chemical compound that is dissolved in a liquid, preferably absorbed in an interface, which determines a set of physico-chemical properties of practical interest, based on which it is classified into:

1) Iones:

a) Anionics.

b) Cationics.

2) Nonionic.

3) Amphoters.

The definition of surfactants as fundamental components of detergents does not necessarily imply that they are present in the formulation in a majority proportion.

4. Reinforcing: are complementary components that improve certain characteristic properties of the fundamental components.

5. Additives: are complementary components of a detergent or a cleaner that provide additional properties to the specific cleaning action.

6. Loads: are the products used to achieve the desired type of presentation and concentration of a detergent or cleaner.

7. Adjuvants: are complementary components of a detergent or a cleaner, which provide particular properties to those of the fundamental components in the specific cleaning action.

8. Washing soap: is the product obtained from the reaction of the acids of an oil or other fatty body with an alkali and that is intended for washing of clothes or miscellaneous objects.

9. Biodegradability: is the biodegradation capacity of surfactants.

10. Biodegradation: is the molecular degradation of the surfactant, resulting from a complex action of living organisms in the environment.

11. Percentage of biodegradability: is the percentage quantity of the biodegradable surfactant according to the official methods in force.

Article 3. Classification.

The products covered by this Regulation are classified by the use to which they are intended, in accordance with the categories set out in Annex I, and may be presented on the market in the form of solids, powder, scales, paste, in liquids, in aerosols or in any other form of presentation that technological development permits.

TITLE II

Requirements for the marketing of products

Article 4. Preconditions for production and marketing.

1. Without prejudice to the applicable industrial legislation, industries, establishments and facilities for the production, packaging and import of detergents and disinfectants for the food industry must be registered in the General Register. Food Health, regulated by Royal Decree 1712/1991 of 29 November.

2. At the time of the first placing on the market of each product, or on the occasion of each amendment of the formula, the marketing officers shall communicate the composition of each formula to the Toxicological Information Service of the Institute of Toxicology, in accordance with the procedures laid down for this purpose by that body. This Institute shall provide the Directorate-General of Public Health and the corresponding organs of the Autonomous Communities, upon request, with the information necessary for the fulfilment of their own competences. Such information may only be used for medical, preventive and curative requirements.

TITLE III

General conditions of the industries, equipment and personnel. Characteristics of the products

Article 5. General conditions of the industries.

All industrial establishments related to the products covered by this Regulation must comply with a design or scheme guaranteeing the appropriate technical-sanitary treatment of raw materials, their products and by-products and that it facilitates the correct application of the various manufacturing practices in the interest of public health.

To this end, the establishments will comply with the following requirements:

1. Manufacture or storage premises and their yeas shall be suitable for use for use with suitable sites or installations, easy and wide access to the convenient distance of any kind of dirt or insalubity.

2. The natural or artificial ventilation and lighting shall be the regulatory and, in any case, appropriate to the capacity and volume of the premises, according to the purpose for which it is intended.

3. It shall at all times have sufficient water to cover the needs of industrial establishments.

The water distribution network will have sufficient number of outlets to ensure the cleaning and washing of premises, facilities and industrial elements. The industry shall have a drinking water circuit with sufficient capacity for the use of personnel.

4. The competent authorities shall have hygienic and changing rooms in number and characteristics as provided for in each case.

5. All premises must be kept constantly in a state of cleanliness and cleanliness, which must be carried out by the most appropriate means to avoid dust or contamination or alterations.

6. All machinery and other components which are in contact with raw materials, products in the making or already processed and, even, packaging, shall be such as to be such that they cannot be transmitted to the material produced Harmful chemical reactions, or to cause harmful chemical reactions. The same precautions shall be taken as regards the containers, transport elements, provisional packaging and storage places. All of these elements will be constructed in such a way that they can be kept in perfect hygiene and cleaning conditions.

7. They shall have services, defences, tools or facilities suitable for their construction and placement to ensure the conditions of hygiene and cleanliness and their non-contamination by proximity or contact with any kind of waste, water waste, smoke, dirt and foreign matter, as well as the presence of insects, rodents, birds and other animals.

8. In addition, any other technical, industrial, health and industrial safety conditions established or established in their respective competences by the public administrations in their different spheres shall be fulfilled.

9. They shall have the appropriate laboratory or contract, for the quality control of raw materials and finished products, governed by a qualified technician.

Article 6. General conditions concerning staff.

The staff involved in the elaboration process will wear the work properly and with due cleanliness and hygiene. It will comply with current labour safety legislation.

Article 7. Characteristics of the raw materials.

1. Biodegradability: the surfactants of the products covered by this Regulation shall comply with the provisions of the legislation in force on biodegradability.

2. Other characteristics: the components of the products covered by this Regulation will be subject to the provisions of Royal Decree 363/1995 of 10 March 1995 approving the Regulation on the notification of new substances and classification, packaging and labelling of dangerous substances, or, where appropriate, the provisions of Royal Decree 1078/1993 of 2 July 1993 on the Regulation on the classification, packaging and labelling of dangerous preparations.

Article 8. Characteristics of the finished products.

Without prejudice to the provisions of Chapter XXXVIII of the Spanish Food Code, approved by Royal Decree 2484/1967 of 21 September, the finished products must have the following characteristics:

1. Liquid dishwashers intended for professional use which are classified as corrosive in accordance with Royal Decree 1078/1993, which is approved by the Regulation on the classification, packaging and labelling of dangerous preparations, must be Market:

a) Colorized in such a way that they can never be confused with water, when they are non-chlorinated preparations.

b) Without incorporating components that may alter their characteristic odour, when they are chlorinated preparations.

2. Generally, products classified as toxic or very toxic for domestic use are prohibited.

3. Detergents and cleaners intended for domestic use or for the food industry shall comply with the following characteristics:

(a) Under the conditions of use recommended by the manufacturer, these products shall not damage the objects on which the user's hands or hands are used.

(b) Food use must be able to be removed from utensils, appliances and installations, being rinsed with drinking water or water vapour, after having exercised its action, with the exception of some brighteners, which in small doses are usually applied to the finish of the cleaning operation.

4. Products that have a shape, smell, colour, appearance, presentation, labelling, volume or size are not allowed, such that consumers, in particular children, are expected to confuse them with food products and by they take them to the mouth, suck them or ingest them.

TITLE IV

Packaging and Labelling

Article 9. Packaging.

The sale of products covered by this technical-health regulation must be made in packaging that meets the following requirements:

1. The materials constituting the packaging and their closures shall not be liable to be attacked by the contents or to form with such combinations which may be dangerous.

2. The packaging and its closures shall be designed and constructed in such a way as to be watertight, strong and solid, in order not to open and to safely resist the efforts of normal handling operations.

3. Packaging of products with a reusable closure system shall have a closure of features and designs such that once opened they can be closed again without losing their watertight character.

4. Products packed in aerosols shall comply with the provisions of Royal Decree 2549/1994 of 29 December 1994 amending the supplementary technical instruction MIE-AP3 of the Regulation of pressure equipment for generators of aerosols.

Article 10. General principles of labelling, presentation and advertising.

The labelling, presentation and advertising of the products covered by this provision will be subject to the following principles:

1. They shall contain effective, accurate and sufficient information of their essential uses and characteristics.

2. They will leave no doubt as to the true nature of the product and will not give rise to confusion in its name with medicines, cosmetics and food.

3. They shall not mislead or mislead by means of inscriptions, signs, anagrams or drawings.

4. Data shall not be omitted or distorted in such a way as to mislead or mislead the consumer or to create a false image of the product.

5. Packaging may not have a form or graphic decoration which may attract or excite the active curiosity of children or mislead the consumer.

6. For products classified as dangerous, no mention shall be made to induce the consumer to make a transfer, in order to dilute the product, to a package other than that of origin, except in the case of:

a) Products classified as irritating.

(b) Products for professional use that are sold in establishments to which the consumer cannot have access.

In the irritant products containing this indication, the person responsible for placing the product on the market shall make available to the consumer, on the same sales places, a package suitable for containing the diluted product with its labelling. corresponding.

In the products bearing this mention, the way in which the transfer is carried out shall be given in detail and the risk involved in the transfer shall be given to any other packaging and, in particular, to any food product.

Article 11. Tagged.

The labelling of the products covered by this Regulation shall contain at least the following data in the official Spanish language of the State:

1. Products which are not classified as dangerous substances or preparations shall indicate:

a) The name or trade name of the preparation and the intended use.

b) The nominal amount (nominal mass or nominal volume) of the content, or number of units where applicable.

(c) The full name and address of the marketing officer established within the European Union, whether the manufacturer, the packer, the importer or the distributor.

The place of provenance or origin shall also be indicated in the case where its omission could mislead the consumer as to the true origin or provenance of the product. Products imported from non-member countries outside the World Trade Organisation shall in any event indicate the country of origin on their labelling.

d) Incompatibilities with some material, if any, within the intended uses.

e) All products in this Regulation must bear the following caption:

"Stay out of reach of children."

Likewise, those who are susceptible to being ingested must also bear the legend:

"Do not ingest."

(f) Components: detergents and cleaning products should indicate the content of the components listed in Annex II to this Regulation provided that they are present in a concentration greater than 0,2 per 100.

Products for exclusively professional use should not necessarily comply with this requirement if the relevant information is provided by means of technical data or security data sheets, or by another system appropriate.

g) Information in case of accidents: the legend "In case of accident consult the Medical Service of Toxicological Information, telephone ...", indicating the telephone number corresponding to that Service.

This data shall be included once correctly completed as required in Article 4 (2).

h) Packaging code: manufacturers will encode packaging so that they can identify the packaging date.

(i) Mode of use: instructions and doses shall be given for proper use of the product, in cases where the omission of the product may cause incorrect use of the product.

In the case of detergents intended for household use for washing clothes on automatic machines, the recommended quantities and/or the dosage instructions, expressed in millilitres or grams, as well as the Equivalence with the dispenser if any, appropriate to a normal washing machine load and according to several classes, specified, water hardness and one or two washing programs.

2. The labelling of products which are classified as dangerous substances or preparations in accordance with their specific Regulations shall include, in addition to the provisions referred to in paragraph 1 of this Article, the provisions laid down in those Regulations.

3. The spray-packed products must also comply with the labelling specifications set out in Royal Decree 2549/1994 of 29 December.

4. The solid soaps for washing, which are the subject of this Regulation, shall comply only with paragraphs 11.1.b), 11.1.c) and 11.1.f) except for the indelible characteristics required in this last paragraph, if it is packaging.

5. Liquid dishwashing products for professional use which are classified as "corrosive" in accordance with Royal Decree 1078/1993, for which the Regulation on the classification, packaging and labelling of dangerous preparations is adopted, shall include in their labelling, in addition to the provisions of the previous paragraphs of this Article, the following:

(a) Legend "Restricted to professional uses", any indication of simultaneous use in the household is prohibited.

b) The legend "Keep only in the source canister".

6. All mandatory insertion legends must be marked with clear, visible, indelible and easily readable characters by the consumer.

Mandatory information may not be included in closures, seals, and other parts that are used when opening the package.

7. The particulars relating to the name and the nominal quantity shall be required in the same visual field.

Similarly, the indications concerning the person responsible, the incompatibilities and the legends must be included in the same visual field.

8. The nominal quantity shall be expressed, using the kilogram or gram, the litre, the centilitre or the millilitre, as measuring units, by means of figures of a minimum height of:

a) 6 millimeters if the nominal amount is greater than 1,000 grams or 100 cents.

(b) 4 millimetres if the nominal amount is between 1,000 grams or 100 centilitres, including, and 200 grams or 20 cents, exclusive.

(c) 3 millimetres, if the nominal amount is between 200 grams or 20 cents, inclusive, and 50 grams or 5 cents, exclusive.

d) 2 millimetres, if the nominal amount is equal to or less than 50 grams or 5 centilitres.

These numbers will be followed by either the unit of measure symbol or its name.

TITLE V

Storage, transport, and sale

Article 12. Storage, transport and sale.

1. Without prejudice to the obligation of compliance with existing transport legislation, the products covered by this Regulation may be transported, stored or sold with food and food, if they are complied with in their all the following conditions:

(a) That the wrappers, packaging and packaging comply with Article 9 of this Regulation, and that in the transport, storage and sale it is ensured, with the best available means, that its contents are not mixed, nor between contact, or exercise any action of any kind on food or food products transported, stored or sold.

(b) That there is a proper material separation and that in the case of the shops, the isolation of each other is ensured, both on the shelves, and in the stores and stores of the establishment.

2. The products covered by this Regulation shall be subject to the provisions of other technical and health regulations relating to the transport, storage and sale of foodstuffs and, in general, to the provisions of the municipal in this respect.

3. The introduction of toys and other objects intended for children within the packaging of the products covered by this Regulation is not permitted.

4. The sale of products classified as toxic or very toxic, as well as those of restricted use to professionals, is not permitted in places where the consumer has direct access.

TITLE VI

Foreign trade

Article 13. Export.

Products subject to this Regulation intended for sale to third countries which do not comply with the technical and health conditions required in this Regulation must be labelled in such a way that they are unequivocally identified. as export products, in order to prevent their consumption on the domestic market. To this end, the packages must bear a red-coloured rhombus, on the background of a different colour, with dimensions of at least 15 × 25 millimetres.

In the event that the packages are labelled in a language other than the official language of the State, they will not need to carry the said diamond.

Article 14. Import.

The import products covered by this Regulation must comply with the provisions adopted in this Royal Decree. However, products lawfully and lawfully marketed in other Member States of the European Union and of the signatories to the Agreement of the European Economic Area, even if they do not comply with the provisions of this Regulation, may free trade on the Spanish territory provided that they maintain information on their labelling equivalent to that required by Articles 10 and 11 and present similar levels of safety for consumers. Such information shall be at least in the official Spanish language of the State.

TITLE VII

Sample sampling and method of analysis

Article 15. Sampling and method of analysis.

In the analytical checks to be carried out on the products referred to in this Regulation, the official methods approved by the provisions in force or, failing that, those recognised as such, shall be used. suitable for the relevant international bodies.

TITLE VIII

Competencies and sanctioning regime

Article 16. Competencies.

The bodies responsible for public administrations shall exercise their respective powers in the application of the provisions of this Regulation and shall coordinate their actions in order for such implementation to be carried out. correctly. The competent bodies of the Autonomous Communities shall be responsible for the supervision and inspection of the correct compliance, in their respective territories, of the same.

Article 17. Sanctioning regime.

The violations of the provisions of this Regulation will be sanctioned in accordance with the provisions of Law 14/1986 of 25 April, General of Health, and Law 26/1984 of 19 July, General for the Defense of the Consumers and Users, and other provisions that apply.

ANNEX I

Non-exhaustive classification of the products covered by this Regulatory by the use to which they are intended

A) Products for dishwashing:

1. Hand-washing detergents.

2. Machine-washing products.

3. Auxiliary products for machine washing (brighteners, salts).

B) Clothing washing products:

1. Detergents.

2. Softeners.

3. Prewash products.

4. Additives (anticalcareous, bleaching).

C) Wash soap.

D) Maintenance and cleaning products:

1. For general use.

2. Clean-up and multipurpose cleaning.

3. Sanitary cleaners.

4. Waxes and cleaners for furniture and woods.

5. Brighteners and cleaners for hard floors.

6. Tissue products (chitamanches, sizing, cloths, and carpets and dyes).

7. Cleaning and cleaning for leather and fur.

8. Cleaners for ovens, microwaves, glass ceramics.

9. Cleaning products and products for the treatment of metal surfaces.

10. Chitagrases.

11. Descaling and unsling.

12. Products for the washing and care of bodies, vehicles and other transport elements.

13. Air fresheners.

E) Products for cleaning the food industry (floors, walls, machinery, containers, tanks, cold chambers and other elements of food production, storage and transport).

F) Maintenance and cleaning products intended for other industrial applications and other professional uses.

ANNEX II

List of mandatory indication components as expressed in article 11.1.f)

Phosphates.

Fosfonates.

Anionic Surfactants.

Cationic Surfactants.

Amphoteric Surfactants.

Nonionic Surfactants.

Oxygen based on oxygen (1).

Chlorine-based bleaching.

EDTA.

Nitrilotriacetic acid.

halogenated phenols and phenols.

Paradiclorobenzene.

Aromatic Hydrocarbons.

Aliphatic Hydrocarbons.

Halogenated Hydrocarbons.

Soap.

Zeolites.

Polycarboxylates.

The indication must be done according to the following percentages scale:

1. Less than 5 per 100.

2. Between 5 per 100 and less than 15 per 100.

3. Between 15 per 100 and less than 30 per 1000.

4. 30 per 100 or more.

Enzymes and preservatives/disinfectants, if added, should always appear on the label, regardless of their concentration.

(1) Expressed in their anhydrous form.