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REACH Conference Praha 2016

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REACH Conference Prague (Pruhonice), May 16 - 17, 2016, Czech republic

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REACH Delivery service

The REACH Delivery service

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Products safety, chemical substances, consumer protection legislation.
Kozmetika PDF   E-mail
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Od 11. júla 2013 smernicu o kozmetických výrobkoch nahradí NARIADENIE EURÓPSKEHO PARLAMENTU A RADY (ES) č. 1223/2009 o kozmetických výrobkoch. Avšak, niektoré ustanovenia nariadenia (ES) č. 1223/2009, vzťahujúce sa na látky, ktoré sú karcinogénne, mutagénne alebo toxické pre reprodukciu (CMR), sú platné od 1. decembra 2010.  Hlavným cieľom tohto nariadenia je chrániť verejné zdravie tým, že zjednotí zákony a predpisy týkajúce sa kozmetických výrobkov v Európskej únii. Toto nariadenie ustanovuje pravidlá pre zloženie, označovanie a balenie kozmetických výrobkov v členských štátov EÚ.

Articles according to REACH PDF   E-mail


According to ECHA Guidance on requirements for substances in articles

Article 3(3) of the REACH Regulation defines an article as “an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition”.

In order to determine whether or not an object fulfils the definition of an article under REACH, the object’s function and its characteristics need to be assessed. (The term “object” can in principle refer to any product in the supply chain)

Ø function of an object - the term “function” in the article definition should be interpreted as meaning the basic principle determining the use of the object

Ø shape of an object means the three-dimensional form of an object, like depth, width and height.

Ø surface of an object means the outermost layer of an object.

Ø design of an object means the arrangement of the “elements of design” in such a way as to best accomplish a particular purpose

The shape, surface and design of an object represent its physical appearance and can be understood as other than chemical characteristics and are not to be confused with physical characteristics that result from the chemistry of the material(s) the object is made of.

According to Article 3(3) of the REACH Regulation the shape, surface or design must be deliberately determined and given during a production step (the “production step” of an article can also be understood to include the assembly of the components (which can themselves be articles) of a complex article (e.g. a laptop)

A set of objects that are merely collected together to be supplied does, on the contrary, not have a particular production step during which a specific shape, surface or design is given to the set or kit. This applies regardless of whether the objects are

Ø used separately (like the different casseroles and pans of a cookware set),

Ø used together (like in a portable power tool consisting of tool, battery and charger), or

Ø assembled into a single object (like a flat pack furniture).

Therefore a set of objects cannot be regarded as one article, but has to be regarded as many articles, substances and/or mixtures.

Substances, mixtures and articles can be contained inside of packaging, such as a carton, a plastic wrapping or a tin can. The packaging does not belong to the substance, mixture or article being packaged and i s therefore to be considered as a separate article under REACH.


A release of substances from articles is intended if it fulfils an accessory function (to be differentiated from the main function) which is deliberately planned and would not be achieved if the substance were not released. (Substances that are released because of ageing of articles, because of wear and tear or as an unavoidable side-effect of the functioning of the article, are generally not intended releases, as the release as such does not provide a function in itself.)

If the release of a substance from an object fulfils the main function of the object, the release is not regarded as “intended release” for the purpose of REACH. In this case the object usually would be considered as a combination of an article and a substance/mixture.

An intended release of a substance from an article has furthermore to occur under (normal or reasonably foreseeable) conditions of use. This means that the substance release has to occur during the service life of the article. Hence, a substance release during the production or disposal phase of the article’s life cycle is not an intended release.

Normal conditions
of use means the conditions associated with the main function of an article.

Reasonably foreseeable conditions of use mean conditions of use that can be anticipated as likely to occur because of the function and appearance of the article (even though they are not normal conditions of use)

Registration of substances in articles

Is required when all conditions listed under Article 7(1) of the REACH Regulation are fulfilled:

Ø The substance is intended to be released under normal or reasonably foreseeable conditions of use

Ø The total amount of the substance present in all articles with intended release (i.e. including the amounts that are not intended to be released) produced or imported by one actor exceeds 1 tonne per year

For a substance in articles that has to be registered, the producer/importer of the articles shall submit a registration dossier to ECHA and the requirements for the registration dossier are in general the same as for manufacturers and importers of the substance.


Candidate List for authorisation

Substances fulfilling one or more of the criteria defined in Article 57 of the REACH Regulation can be identified as “substances of very high concern” (SVHC) and put on the “Candidate List for authorisation”

More information about candidate list and authorisation proccess you can find on our SVHC site >>

Notification according to Article 7(2)

Notification of substances in articles is required of producers and importers of articles when all conditions of Article 7(2) are met:

Ø The substance is included in the Candidate List for authorisation.

Ø The substance is present in articles produced and/or imported above a concentration of 0.1% (w/w).

Ø The total amount of the substance present in all articles produced and/or imported, which contain more than 0.1% (w/w) of the substance, exceeds 1 tonne per actor per year.

Obligations according to Article 33

The aim of Article 33 is to ensure that sufficient information is communicated down the supply chain to allow the safe use of articles.

Ø A supplier of articles containing a SVHC included on the Candidate List for authorisation in a concentration above 0.1% (w/w) has to provide relevant safety information about this substance available to him to the recipients of these articles (Article 33(1)).

Ø If no particular information is necessary to allow safe use of the article containing a substance from the Candidate List, as a minimum the name of the substance in question has to be communicated to the recipients.

Ø The information is to be provided to the recipients automatically, i.e. as soon as the substance has been included on the Candidate List for authorisation. Note that the term “recipients” refers to industrial or professional users and distributors, but not to consumers.

Ø Upon request of a consumer, the same supplier of articles has to provide relevant safety information about the SVHC available to him also to this consumer (Article 33(2)). The consumer has to be provided with this information within 45 calendar days of the request and free of charge

As concerns the obligations to communicate information on substances in articles in general

(i.e. communication with recipients and consumers), please note that:

Ø There is no tonnage trigger for these obligations (i.e. they also apply below 1 tonne per year).

Ø Packaging is always to be treated as article(s) separate from the contents of the packaging. Therefore, the obligations to communicate information on substances in articles also apply to packaging materials.

Ø The substance concentration threshold of 0.1% (w/w) applies to the article as supplied.

Ø The obligations also apply to articles which were produced or imported before the substance was included in the Candidate List and are supplied after the inclusion. Thus, the date of supply of the article is the relevant date.

Ø The substance name to be communicated is the one appearing on the Candidate List for authorisation.


article producer is a company, if it produces articles within the EEA, regardless of how the articles are produced and where they are placed on the market. (Producer of an article: means any natural or legal person who makes or assembles an article within the Community (Article 3(4))).

article importer is any company located inside the EEA that imports articles from countries´that are located outside the EEA. (Importer: means any natural or legal person established within the Community who is responsible for import (Article 3(11)); import: means the physical introduction into the customs territory of the Community (Article 3(10))).

article suppliers are article producers and importers (as well as other actors in the supply chain such as retailers), if they place articles on the market in the EEA. Thus, the role of article supplier is irrespective of whether the supplier produces the articles himself or whether he purchases them (inside or outside of the EEA). (Supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market (Article 3(33)), including retailers (Article 3(14))).

Chemical safety of articles PDF   E-mail

There is a wide range of different chemicals used in current products and many dangerous substances have spread into the environment from the manufacture, use and disposal of products. As part of the management of chemicals vv EU legislation on product safety is a waste, design of products and chemicals to reduce the hazardous effects of chemicals in products.

New security measures chemicals in products are reflected in various legislative regulations of the EU. Among the latest revised undoubtedly include: REACH Regulation (EC no. 1907/2006), New Toys Safety Directive 2009/48/EC, the European Parliament and Council. 305/2011 of the Construction Products Regulation of the European Parliament and the Council 1223/2009 of cosmetic products. Comprehensive overview of legislation is given at the bottom.

Toys PDF   E-mail

The new European Directive 2009/48/EC on safety of toys was published 30th June 2009 in the Official Journal and entered into force on 20 July 2009. Implementation of the legislation in EU member states must be carried out by 20 January 2011.

This Directive lays down rules on toy safety and free movement within the Community and applies to products designed or determined whether exclusively or not already, for use in play by children under the age of 14 years - "toys" This new directive, which enhances existing trade rules with toys made ​​in the EU or imported into its territory, limiting the injuries caused by toys and achieve long-term benefits in health

The directive established a transitional period:

  • 2 years: during this transitional period (until July 20, 2011) may be used for new and old directive. Obligations under the new Directive relating to toys placed on the market after 20 July 2011. Toys comply with the provisions of the old Directive. 88/378/EEC, can remain on the market, if placed on the market before 20 July 2011.
  • 4 years: the requirements for chemicals (up to July 20, 2013) Toys which do not comply with the requirements of the new chemical may be available on the market if they meet the chemical requirements of Directive 88/378/EEC and have been on the market before 20th July 2013.

The main changes compared to the original Directive 88/378/EEC toys are:

  • EC declaration of conformity: Each toy to be placed on the market is undergoing a conformity assessment procedure in the new Directive is the added requirement for a declaration of conformity drawn up by the manufacturer.
  • Evaluation of safety / risk assessment: It must be made ​​a specific assessment of the safety / risk assessment. Manufacturers are required to identify all risks (chemical, physical, mechanical, electrical, flammable, radioactive and health hazards) that may pose a toy. In the case of chemicals includes an assessment of the likelihood of banned or restricted substances in toys, and manufacturers should be required to maintain the safety assessment of technical documentation to the market surveillance authorities to carry out their tasks. Document the safety assessment, the manufacturer must keep the technical documentation for ten years after placing a toy on the market.
  • Production control: The directive sets out the requirements for production control. Internal production control is based on the manufacturer's own responsibility and requires its own verification and monitoring of the manufacturing process the manufacturer to ensure compliance of manufactured products.
  • The specific chemical requirements listed in Annex II, section 3 properties. Toys must be designed and constructed so as to pose no risk of adverse effects on human health due to exposure to chemical substances or mixtures, which are composed or toys that contain all the toys and must comply with general Community legislation on chemical substances (such legislation are very broad but important piece of legislation is the Regulation no. 1907/2006 (REACH)).
  • Requirements for toys sold with food: Toys in food or mixed with food must have their own packaging. This package upon delivery must be of such dimensions as to prevent its being swallowed and / or inhaled.

The EU Commission has issued a handbook (Handbook for the application of the Directive), to serve as a manual for all parties, directly or indirectly involved in Directive 2009/48/EC. This guide aims to provide guidance to ensure that the information provided in the instructions and warnings that consumers, who buy a toy or play with it, accessible and understandable, so that the toy properly and safely.

Toys legislation in adobted EU member states

Austria - Toys Ordinance 2011 BGBl. II No. 203/2011  (in German)

Hungary - A child's toy safety standards for assessment and Certification (in Hungarian)

Germany - Regulation on the Safety of Toys in German

Poland - Essential requirements for toys in (Polish)

United Kingdom:

- The Toys (Safety) Regulations 2011 No. 1881
-The Toys (Safety) (Amendment) Regulations 2010  No. 1928
-The Magnetic Toys (Safety) (Revocation) Regulations 2009 No. 1347
-The Magnetic Toys (Safety) Regulations 2008 No. 1654
-The Toys (Safety) Regulations 1995 No. 204
-The Toys (Safety)(Amendment) Regulations 1993 No. 1547
-The Toys (Safety) Regulations 1989 No. 1275
-The Benzene in Toys (Safety) Regulations 1987 1987 No. 2116