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Member States should lay down provisions on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Los Estados miembros han de establecer el régimen de sanciones aplicable a las infracciones de las disposiciones del presente Reglamento y garantizar su aplicación... |
Those penalties should be effective, proportionate and dissuasive. Dichas sanciones deben ser eficaces, proporcionadas y disuasorias. 32009R1223_en |
(67) (67) 32009R1223_en |
Economic operators as well as Member States and the Commission need sufficient time to adapt to the changes introduced by this Regulation. Los operadores económicos, los Estados miembros y la Comisión necesitan un tiempo suficiente para adaptarse a los cambios que introduce el presente Reglamento. 32009R1223_en |
Therefore it is appropriate to provide for a sufficient transitional period for that adaptation. Por lo tanto, es conveniente prever un período transitorio suficiente para dicha adaptación. 32009R1223_en |
However, in order to ensure a smooth transition, economic operators should be allowed to place on the market cosmetic products which comply with this Regulation before the expiry of that transitional period. No obstante, con el fin de garantizar una transición sin tropiezos, debe darse a los operadores económicos la po... |
(68) (68) 32009R1223_en |
In order to enhance the safety of cosmetic products and strengthen the market surveillance, cosmetic products placed on the market after the date of application of this Regulation should comply with its obligations regarding safety assessment, the product information file and notification, even if similar obligations h... |
(69) (69) 32009R1223_en |
Directive 76/768/EEC should be repealed. Procede asimismo derogar la Directiva 76/768/CEE. 32009R1223_en |
However, in order to ensure appropriate medical treatment in the event of difficulties and to ensure market surveillance, the information received pursuant to Article 7(3) and Article 7a(4) of Directive 76/768/EEC concerning cosmetic products should be kept by the competent authorities for a certain period of time and ... |
(70) (70) 32009R1223_en |
This Regulation should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Part B of Annex IX. El presente Reglamento debe entenderse sin perjuicio de las obligaciones de los Estados miembros relativas a los plazos de ... |
(71) (71) 32009R1223_en |
Since the objective of this Regulation, namely the achievement of the internal market and a high level of protection of human health through the compliance of cosmetic products with the requirements laid down in this Regulation, cannot be sufficiently achieved by the Member States and can therefore, by reason of the sc... |
In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, De conformidad con el principio de proporcionalidad enunciado en dicho artículo, el presente Reglamento no excede de lo necesario para alcanzar dicho ... |
HAVE ADOPTED THIS REGULATION: HAN ADOPTADO EL PRESENTE REGLAMENTO: 32009R1223_en |
CHAPTER I CAPÍTULO I 32009R1223_en |
SCOPE, DEFINITIONS ÁMBITO DE APLICACIÓN Y DEFINICIONES 32009R1223_en |
Article 1 Artículo 1 32009R1223_en |
Scope and objective Ámbito de aplicación y objetivo 32009R1223_en |
This Regulation establishes rules to be complied with by any cosmetic product made available on the market, in order to ensure the functioning of the internal market and a high level of protection of human health. El presente Reglamento establece las normas que deben cumplir todos los productos cosméticos comercializad... |
Article 2 Artículo 2 32009R1223_en |
Definitions Definiciones 32009R1223_en |
1. 1. 32009R1223_en |
For the purposes of this Regulation, the following definitions shall apply: A efectos del presente Reglamento se entenderá por: 32009R1223_en |
(a) a) 32009R1223_en |
‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them,... |
(b) b) 32009R1223_en |
‘substance’ means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substan... |
(c) c) 32009R1223_en |
‘mixture’ means a mixture or solution composed of two or more substances; «mezcla»: una mezcla o solución compuesta por dos o más sustancias; 32009R1223_en |
(d) d) 32009R1223_en |
‘manufacturer’ means any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark; «fabricante»: toda persona física o jurídica que fabrica un producto, o que manda diseñar o fabricar un producto, y que come... |
(e) e) 32009R1223_en |
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market; «distribuidor»: toda persona física o jurídica de la cadena de suministro, distinta del fabricante o del importador que comercializa un produc... |
(f) f) 32009R1223_en |
‘end user’ means either a consumer or professional using the cosmetic product; «usuario final»: el consumidor o el profesional que utiliza el producto cosmético; 32009R1223_en |
(g) g) 32009R1223_en |
‘making available on the market’ means any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge; «comercialización»: todo suministro, remunerado o gratuito, de un producto cosmético para su distr... |
(h) h) 32009R1223_en |
‘placing on the market’ means the first making available of a cosmetic product on the Community market; «introducción en el mercado»: primera comercialización de un producto cosmético en el mercado comunitario; 32009R1223_en |
(i) i) 32009R1223_en |
‘importer’ means any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market; «importador»: toda persona física o jurídica establecida en la Comunidad que introduce un producto cosmético de un tercer país en el mercado comunitario; 32009R1223_... |
(j) j) 32009R1223_en |
‘harmonised standard’ means a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on ... |
(k) k) 32009R1223_en |
‘nanomaterial’ means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm; «nanomaterial»: un material insoluble o biopersistente fabricado intencionalmente que presenta una o más dimensiones externas o una es... |
(l) l) 32009R1223_en |
‘preservatives’ means substances which are exclusively or mainly intended to inhibit the development of micro-organisms in the cosmetic product; «conservantes»: las sustancias cuya finalidad exclusiva o principal sea inhibir el desarrollo de microorganismos en el producto cosmético; 32009R1223_en |
(m) m) 32009R1223_en |
‘colorants’ means substances which are exclusively or mainly intended to colour the cosmetic product, the body as a whole or certain parts thereof, by absorption or reflection of visible light; in addition, precursors of oxidative hair colorants shall be deemed colorants; «colorantes»: las sustancias cuya finalidad exc... |
(n) n) 32009R1223_en |
‘UV-filters’ means substances which are exclusively or mainly intended to protect the skin against certain UV radiation by absorbing, reflecting or scattering UV radiation; «filtros ultravioleta»: las sustancias cuya finalidad exclusiva o principal sea proteger la piel contra determinadas radiaciones ultravioletas abso... |
(o) o) 32009R1223_en |
‘undesirable effect’ means an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product; «efecto no deseado»: una reacción adversa para la salud humana atribuible a la utilización normal o razonablemente previsible de un producto cosmético; 32009R1223_en |
(p) p) 32009R1223_en |
‘serious undesirable effect’ means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death; «efecto grave no deseado»: un efecto no deseado que produce una incapacidad funcional temporal o permanente, una ... |
(q) q) 32009R1223_en |
‘withdrawal’ means any measure aimed at preventing the making available on the market of a cosmetic product in the supply chain; «retirada»: toda medida destinada a impedir la comercialización de un producto que se encuentra en la cadena de suministro; 32009R1223_en |
(r) r) 32009R1223_en |
‘recall’ means any measure aimed at achieving the return of a cosmetic product that has already been made available to the end user; «recuperación»: toda medida destinada a obtener la devolución de un producto cosmético que ya ha sido puesto a disposición del usuario final; 32009R1223_en |
(s) s) 32009R1223_en |
‘frame formulation’ means a formulation which lists the category or function of ingredients and their maximum concentration in the cosmetic product or gives relevant quantitative and qualitative information whenever a cosmetic product is not covered or only partially covered by such a formulation. «fórmula marco»: una ... |
The Commission shall provide indications for the establishment of the frame formulation and adapt them regularly to technical and scientific progress. La Comisión proporcionará indicaciones para el establecimiento de la fórmula marco y las adaptará periódicamente al progreso científico y técnico. 32009R1223_en |
2. 2. 32009R1223_en |
For the purposes of point (a) of paragraph 1, a substance or mixture intended to be ingested, inhaled, injected or implanted into the human body shall not be considered to be a cosmetic product. A efectos del apartado 1, letra a), no se considerará producto cosmético una sustancia o mezcla destinada a ser ingerida, inh... |
3. 3. 32009R1223_en |
In view of the various definitions of nanomaterials published by different bodies and the constant technical and scientific developments in the field of nanotechnologies, the Commission shall adjust and adapt point (k) of paragraph 1 to technical and scientific progress and to definitions subsequently agreed at interna... |
That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3). Esta medida, destinada a modificar elementos no esenciales del presente Reglamento, se adoptará con arreglo al procedimiento de reglamentaci... |
CHAPTER II CAPÍTULO II 32009R1223_en |
SAFETY, RESPONSIBILITY, FREE MOVEMENT SEGURIDAD, RESPONSABILIDAD Y LIBRE CIRCULACIÓN 32009R1223_en |
Article 3 Artículo 3 32009R1223_en |
Safety Seguridad 32009R1223_en |
A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking account, in particular, of the following: Los productos cosméticos que se comercialicen serán seguros para la salud humana cuando se utilicen en las condiciones norma... |
(a) a) 32009R1223_en |
presentation including conformity with Directive 87/357/EEC; la presentación incluida la conformidad con la Directiva 87/357/CEE; 32009R1223_en |
(b) b) 32009R1223_en |
labelling; el etiquetado; 32009R1223_en |
(c) c) 32009R1223_en |
instructions for use and disposal; las instrucciones de uso y eliminación; 32009R1223_en |
(d) d) 32009R1223_en |
any other indication or information provided by the responsible person defined in Article 4. cualquier otra indicación o información proporcionada por la persona responsable definida en el artículo 4. 32009R1223_en |
The provision of warnings shall not exempt persons defined in Articles 2 and 4 from compliance with the other requirements laid down in this Regulation. La presencia de advertencias no eximirá a las personas definidas en los artículos 2 y 4 del cumplimiento de las demás obligaciones previstas en el presente Reglamento.... |
Article 4 Artículo 4 32009R1223_en |
Responsible person Persona responsable 32009R1223_en |
1. 1. 32009R1223_en |
Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market. Sólo se introducirán en el mercado los productos cosméticos para los que se designe una persona física o jurídica como «persona responsable» en la Comunidad. 32009R1223_en |
2. 2. 32009R1223_en |
For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation. Para cada producto cosmético introducido en el mercado, la persona responsable garantizará el cumplimiento de los requisitos pertinentes establecidos en el presente Re... |
3. 3. 32009R1223_en |
For a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer established within the Community shall be the responsible person. Para los productos cosméticos fabricados en la Comunidad que no sean seguidamente exportados e importados de nu... |
The manufacturer may designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing. El fabricante podrá, por mandato escrito, designar como persona responsable a una persona establecida en la Comunidad, que aceptará por escrito. 32009R1223_en |
4. 4. 32009R1223_en |
Where, for a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer is established outside the Community, he shall designate, by written mandate, a person established within the Community as the responsible person who shall accept in writ... |
5. 5. 32009R1223_en |
For an imported cosmetic product, each importer shall be the responsible person for the specific cosmetic product he places on the market. En el caso de los productos cosméticos importados, cada importador será la persona responsable para el producto cosmético específico que introduzca en el mercado. 32009R1223_en |
The importer may, by written mandate, designate a person established within the Community as the responsible person who shall accept in writing. El importador podrá, por mandato escrito, designar como persona responsable a una persona establecida en la Comunidad, que aceptará por escrito. 32009R1223_en |
6. 6. 32009R1223_en |
The distributor shall be the responsible person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected. El distribuidor será la persona responsable si introduce un prod... |
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