Laws & Regulations

Mandatory is the compliance with legal requirements to offer safe products for the european market.

We would like to give you an overview about the most important directives and regulations of our range of products.

Following overview is an assistance, does not claim that this list is complete and certainly does not replace an individual consultation.

 


 

Legal basis, general information

EU Directive 2001/95/EG, general product safety

Standards, general information

EU Regulation VO 1935/2004 - Foodstuffs

CE labelling

EU Directive 2011/65/EG RoHS and 2002/96/EU - WEEE

EU Directive 2009/48/EG Safety of toys

EU regulation VO 1907/2006 - REACh

RAPEX

 


 

 

Legal basis, general information

 

General information – Europe / Germany

EU Directives

Directives are legal acts of the European Union. These are general rules, which have to be implemented into national law within a particular period, mostly 2 years. These are binding with regard to the objectives.

In Germany they normally need to be transcribed into a formal law or a regulation.

Example:
Toy guideline: EG directive 2009/48/EG valid from 20.07.2011 (chemical requirements: valdi from 20.07.2013) – formerly: 88/378/EWG.

EU Regulation

A EU regulation is a legal act, which has prevalence, is binding in its entirety and directly applicable in all member states of the EU.

It does not require transposition into formal law.

It is valid within 28 days, unless no transitional periods are set.

Example:
Regulation 1935/2004 relating to materials and articles intended to come into contact with foodstuffs.

 

Germany

Country-specific laws

A law is a collection of generally binding legal norms, which is enacted by legislator in a formal procedure. Laws are enacted by one country and are only valid there.

Examples for German laws:
ProdSG – Act on making products available on the market
LFGB – Food, consumer goods and feed code

Country-specific regulations

As well a law, a regulation justifys rights and obligations to each and is therefore valid for each, however it will not be adopted by a formal legislative procedure. Regulations enacted by countrys, which normally implements an European directive into national law.

Examples for German regulations:
Regulation about safety of toys (2nd regulation on product and safety act)
Regulation about the provision of personal protective supplies on the market (8th regulation on ProdSG)

 

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EU Directive 2001/95/EG – general product safety

mplemented in Germany with ProdSG (formerly GPSG) and entered into force on 01.12.2011.
Top priority: protection of safety and health of users against unsafe products.

ProdSG regulates all requirements according to safety, labelling and monitoring of products, which are provided on the market.

„Additional requirements on the supply of consumer products on the market“ is set in §6, that in consideration of reasonable exceptions all consumer products are equipped with following data:

   information about safe use is provided (§6 (1) 1.) (Instructions)
   announcement of contact address (§6 (1) 2.) (Name and address of a distributor within the EU)
   clear labelling of identification (§6 (1) 3.) (Article description and number)

These provisions are implemented by elasto form KG in all distributed products.

As ProdSG prescribed under §6 (2), redemption of unsafe products from the market by regular callback is also anchored in the quality management system of the elasto form KG.

 

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Standards

Standards (DIN, EN, ISO) are recommendations and technical proposals to prove that requirements of regulations and directives are fulfilled. Are these recommendations fulfilled, it is considered that the product complys with the current state of the art. Standards specify requirements and limits of products, which verify in accordance with defined testing and measuring equipments, if a product fulfills the standard and therefore the regulation or guideline.

Standards shall ensure that products are always tested under the same conditions. All testing institutes that test something according to standard and are accredited, have to be tested in accordance with described means and with defined test equipment. This ensures that test reports are comparable where results are held.

Normen

 

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EU Regulation VO 1935/2004 – materials and objects, that are intended to come into contact with foodstuffs.

This general agreement is valid in Germany and all EU member states from 27.10.2006.

Top priority of the regulation: materials and objects shall be manufactured so that their material components pass under normal and predictable use conditions, which don't threaten the health of the consumer. There may only be a small amount passing to the foodstuff, which would not lead to a change on the composition of the food and which would not affect the food regarding to smell and taste.

This regulation controls all materials (such as cork, rubber, glas, metal, plastics, silicons, wood) and objects (such as aluminium foils, cookware, dishes, plastic storage boxes, metal, ceramic/porelain), which are intended to get into contact with foodstuff.

EU regulation 10/2011 is for materials and objects made of plastic, which are intended to get into contact with foodstuff. This regulation lists substances (positive list), which may be used for the production of foodstuff commodity. These listed substances are hygienically assessed and valued. Furthermore substance specific migration limits have been specified. This list is limited to plastics and cellophane.

elasto form KG stores suitable documents for foodstuff commodity made of plastic, to prove conformity with the aforementioned regulations. These are made accessible for responsible authorities of the requirements. Customers receive a conformity declaration.

Warning: The aforementioned don't provide CE labelling. Foodstuff commodity may not be marked with CE!

 

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CE labelling

CE = Communautés Européennes

The manufacturer confirms by installation of a CE label, that the product complys with the requirements of an applicable european guideline.The CE label may only be installed by the manufacturer or their representatives. It is not a test mark which is assigned by a certification body.

The mark is regulated in EU guideline 93/68/EWG.
The size must be at least 5mm and the proportions need to be kept if resized.

Warning! CE labelling is in compliance with ProdSG §7 (2) regulated as follows:
A product must be marked, if prescribed by a guideline.
A product may not be marked with CE, if it is not prescribed by a guideline or regulation! (Prohibition!)

 CE is:
  not a mark of origin
  not a qualtiy mark
  not a standard mark

CE relates only to products.
CE only treats minimum security requirements.
CE ist prescribed by law.

CEPassport for the european single market inter alia for following products:

toys

personal protective equipment

medical products

electrical and electronic equipment (low voltage, EMV, RoHS)

 

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WEEE

Directive 2002/96/EG about electrical and electronic waste
(WEEE – Waste Electrical and Electronic Equipment) is in Germany transcribed with ElektroG as well.

Top priority: Reducing pollutants in electronics as well as avoidance and reduction of electronic waste by reuse.

Recovery and recycling of waste is assumed by the manufacturer, so that private households can return their waste free of charge at municipal collection points.

elasto form KG is registered in Germany and has the EAR (electronic waste register) number DE 442 174 42.

 


 

RoHS

Directive 2011/65/EG restricting the use of certain hazardous substances in electrical and electronic equipment (RoHS – Restriction of hazardous substances) – formerly 2002/95/EU, is valid for all members of the EU.

Top priority: Banish problematic substances from electronical and electronic equipment, such as leaded solder connections or toxic flame retardants when producing cables. The aim is to develop and introduce corresponding substitue products.

Regulated substances: lead, cadmium, quicksilver, chrome VI connections, polybrominated biphenyl (PBB), polybrominated diphenyl ethers (PBDE).

 

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EU Directive 2009/48/EG – Safety of toys

EU Directive 2009/48/EG about safety of toys from 18.06.2009 is valid for all members of the EU since 20.07.2011 or with regard to the chemical requirements since 20.07.2013.

  The old directive 88/378/EWG from 03.05.1988 is repealed and the normalized line DIN EN 71 is revised regularly and adjusted to the state of the art.

  The directive was implemented with the 2nd regulation to the equipment and product safety act in Germany since 20.07.2011.

Top priority: Protection of the security and health of children under 14 years of age against unsafe toys.

The compliance of the toys directive is assumed, if

  the requirements of the harmonised standards EN 71, Part 1, 2 and 3 from a toy are fulfilled. Documented in test reports from accredited testing institutes or on the manufacturer's own responsibility, as far as he has expert knowlege and test equipment.

  the requirements of more chemical substances, such as phthalates, AZO colourings, formaldehyde in accordance to relevant directives and REACh regulation are fulfilled.

  technical documents, such as safety evaluation, bills of material (BOM), safety data sheets of chemicals and descriptions of the conformity assessment procedures, in each case related on each product.

  all necessary labels are installed.

  if necessary, a manual is attached.

 

elasto form KG stores all technical documents and distributes safe toys. On request documents are made accessible for responsible authorities. Customers receive a conformity declaration, which confirms the compliance with the toys directive.

 

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EU regulation VO 1907/2006 – REACh

REACh stands for Registration, Evaluation, Authorisation and Restriction of Chemicals.
The REACh regulation came into force on 01.07.2007 in all countrys of the EU (as well as Iceland, Liechtenstein and Norway).
 

Objective of the EU:

  Collection of physical, chemical, toxicological and ecotoxicological data about chemical substances. Advancement of alternative assessment tools for dangers arising from these substances (such as minimizing animal testings) and take apporopriate action.

  Improvement of the health protection of man and beast, improved care and protection of the environment by means of minimizing dangers caused by chemicals.

  Replacement of particularly critical substances by less critical substances.

Until 2020 all chemicals should be produced and used, so that detrimental effects to the human health and environment are kept as low as possible.

„No data – no market“: Substances, without any sufficient knowlege, may not be produced and distributed.

In non-compliance with the REACh-VO the ChemSanktionsV is valid in Germany since 23.07.2013. It determines:
  Fines applied to the infringements against disclosure obligation (up to 50,000 Euro),
  Imprisonment for violations against restrictions (up to 5 years).

Attachment XVII regulates prohibitions and restrictions of substances, mixtures and products, which are not produced or produced in a restricted way on the basis of more unacceptable risks for human health and environment to place on the market or to be used.
Specific use bans for substances, such as cadmium in plastic products, phthalate in toys, tuluol in glues and color sprays etc.

Candidate list, substances of very high conern (SVHC).
(http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp)

Information about harmful effects on human (CRM substances: carcinogenic, mutagenic, toxic for reproduction) and environment (PBT, persistent, bioaccumulative, toxic substances) were compiled for the listed substances and these substances are subject to extensive information obligation.

elasto form KG distributes exclusively products, which considers the use ban. Products are aligned regularly with substances of the candidate list. As far as we can determine that our products are not needed to provide notice, we will inform our clients unsolicited and coordinate in an individual case suitable measures with you.

 

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RAPEX

RAPEX is a rapid alert system of the EU for all dangerous consumer goods, except for foods and medicines as well as medical equipment.

The commission releases every friday a weekly overview about dangerous products, which you have reported from the national authorities (RAPEX reports).

In this weekly overview are all informations about the product, while the obvious dangers and measures are summarized, which are taken in the country concerned.

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