The New Approach in Setting Product Standards for Safety, Environmental Protection and Human Health
Appendix A
Annexes to Background Document for Sessions I and II
1.1 Annex I
1.1.1 Product areas covered by New Approach Directives1
Directive |
Product Area |
Mandated Standards 20002 |
90/396/EEC |
Appliances burning gaseous fuels |
95 |
2000/9/EC |
Cableway installations designed to carry persons |
|
89/106/EEC |
Construction products |
1004 |
89/336/EEC |
Electromagnetic compatibility |
40 |
94/9/EC |
Equipment and protective systems in potentially explosive atmospheres (ATEX) |
96 |
93/15/EEC |
Explosives for civil use |
19 |
92/42/EEC |
Hot water boilers |
|
95/16/EC |
Lifts |
19 |
73/23/EEC |
Low voltage equipment |
|
90/385/EEC |
Medical devices: Active implantable |
49 |
93/42/EEC |
Medical devices: General |
215 |
98/79/EC |
Medical devices: In vitro diagnostic |
19 |
90/384/EEC |
Non-automatic weighing instruments |
|
89/686/EEC |
Personal protective equipment |
327 |
97/23/EC |
Pressure equipment |
766 |
99/5/EC |
Radio and telecommunications terminal equipment |
|
94/25/EC (proposed amendment COM(2000)639 final) |
Recreational craft |
49 |
96/57/EC |
Refrigeration appliances |
|
98/37/EC |
Safety of machinery |
734 |
88/378/EEC |
Safety of toys |
11 |
87/404/EEC |
Simple pressure vessels |
47 |
98/13/EC |
Telecommunications terminal and satellite earth station equipment |
|
1.1.2
Product areas covered by New Approach Directives, but which do not provide for the CE
marking
Directive |
Product Area |
Mandated Standards 20003 |
96/98/EC |
Marine Equipment |
|
94/62/EC |
Packaging and packaging waste (for marking see table below) |
15 |
2001/16/EC |
Rail systems, Conventional |
|
96/48/EC |
Rail systems, High speed |
|
1.1.3
Product areas covered by proposals for New Approach Directives
Directive |
Product Area |
Proposal in preparation |
Electrical and electronic equipment |
COM(2000)566 final |
Measuring Instruments |
COM(96)191 final |
Packaging, marking of |
COM(93)322final |
Precious metals |
1.2 Annex II
Examples of standardisation in EU legislation
Parliament and Council Directive 94/27/EC: A Directive with many characteristics of a New Approach Directive
The Parliament and Council Directive 94/27/EC was adopted in 1994 as the twelfth amendment of Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations. Directive 94/27 amends the Annex to Directive 76/769 by banning the use of nickel and its compounds in certain products.
The Annex describes the products covered by the Directive.
The first indent deals with nickel containing objects intended for pierced ears and other pierced parts of the body:
" in post assemblies which are inserted into pierced ears and other pierced parts of the human body during epithelization of the wound caused by piercing, whether subsequently removed or not, unless such post assemblies are homogeneous and the concentration of nickel - expressed as mass of nickel to total mass - is less than 0,05 %;"
This indent specifies the nickel concentration permitted in these assemblies. The method of analysis of nickel in these products is not specified.
The second indent deals with nickel products coming into direct and prolonged contact with the skin:
" in products intended to come into direct and prolonged contact with the skin such as:
 | earrings, |
| necklaces, bracelets and chains, anklets, finger rings, |
| wrist-watch cases, watch straps and tighteners, |
| rivet buttons, tighteners, rivets, zippers and metal marks, when these are used in garments |
if the rate of nickel release from the parts of these products coming into direct and prolonged contact with the skin is greater than 0.5 mg/cm²/week;"
This indent specifies the permitted nickel release rate, but does not specify how this should be measured.
The third indent deals with the same type of products as listed in the second indent, but which have been covered by a non-nickel containing layer:
" in products such as those listed in point 2 where these have a non-nickel coating unless such coating is sufficient to ensure that the rate of nickel release from those parts of such products coming into direct and prolonged contact with the skin will not exceed 0,5 ug/cm²/week for a period of at least two years of normal use of the product."
This indent addresses the expected life of the protective non-nickel containing coating layer, and specifies that this coating should last long enough to ensure that the nickel release rate is not exceeded for a period of at least two years. The indent does not specify how this should be measured.
The Directive makes a specific reference to policy related to consumer protection. The second "whereas" clause makes a direct reference a Council resolution on the subject:
"Whereas work on the internal market should gradually improve the quality of life, health protection and consumer safety; whereas the measures proposed by this Directive are in line with the Council resolution of 9 November 1989 on future priorities for relaunching consumer protection policy;"
As described above, the Parliament and Council Directive sets a clear cut-off value for the nickel release, but does not specify methods for measuring either the nickel release rate, or the methods to test whether products covered by a non-nickel layer will show an acceptable nickel release rate for at least two years of normal use. The Directive recognises that test methods are required for the Directive to be operational and in the fourth "whereas" clause accepts the need for a European Standard:
"Whereas the test methods to be used in demonstrating conformity with this Directive should be defined and published before the Directive is implemented; whereas these test methods should be the subject of a European standard;"
The Directive makes no specific reference to the New Approach, although it is clearly the intention that the required standards should be developed by CEN under a mandate similar to those drawn up under the New Approach.
The Directive also makes implementation of the Directive dependent on the adoption of these standards:
"Article 2
1. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive not later than six months after publication by the Commission in the Official Journal of the European Communities, of the standards adopted by the European Committee for Standardization (CEN) on all the test methods used in demonstrating the conformity of the products with this Directive, or six months after the adoption of this Directive if that date is later than the former, so that:
| - | six months after the expiry of one or other of those periods, whichever is applicable, no manufacturer or importer may place on the market products which fail to comply with this Directive, |
| - | 18 months after the expiry of one or other of those
periods, whichever is applicable, products which fail to comply with this Directive cannot
be sold or made available to the final consumer, unless they have been placed on the
market before the expiry of the period in question. |
| They shall forthwith inform the Commission thereof." |
This text sets a date for the Member States to adopt the necessary legislation not less than six months after publication by the Commission in the OJ of the CEN standards adopted. The additional, somewhat complicated text, deals with the possibility of these standards being adopted before the Directive itself comes into force.
In the event, there was a considerable delay in the adoption of the relevant standards, and the publication of these standards by the Commission in the Official Journal. The first standard EN 1810-1998, deals with the measurement of the nickel in piercing assemblies, the second EN 1811-1999 with measurement of the nickel release rate, and the third EN 12472-1999 with the accelerated wear and corrosion to be used for the detection of nickel release from coated items.
Reference to these standards was published as a Commission Communication in the Official Journal, C205, on 20th. July, 1999, page 5, over five years after the publication of the Parliament and Council Directive.
This is an example of the use of standardisation in a Directive, with many of the characteristics of the New Approach, but with significant differences.
Firstly, whilst the Directive makes a specific reference to Consumer policy, the New Approach is not specifically mentioned, even though the method is closely followed.
The "essential requirements" are clearly formulated in the Directive, as the three indents in the Annex. In particular, the cut-off limits for nickel content and nickel release, which many might consider as politically sensitive decisions are specified.
In a conventional New Approach Directive, there is the possibility of producers having a choice between demonstrating compliance with the essential requirements directly, or by reference to a standard. Here there is no such choice.
Since in a conventional New Approach Directive, there is the possibility of producers having a choice between demonstrating compliance with the essential requirements directly, or by reference to a standard, implementation of the Directive does not formally need to be linked to the adoption of the relevant standards (although clearly any Directive would be clearly more operational with the appropriate standards in place). The requirements of this Directive, that standards should be adopted before implementation was possible, has lead to a delay of rather more than five years between publication of the Directive in the Official Journal, and the obligation on the Member States to implement its provisions. Delay in the adoption, for whatever reason, has therefore considerable consequences for the implementation of the measure. A delay that is moreover effectively out of the control of those responsible for the primary legislation.
1.3 Annex III
Examples of standardisation in EU legislation
Product groups outside the New Approach where standardisation addressing environmental aspects of these product groups has been developed
Two product groups are supported by CEN Technical Committees (TCs): CEN/TC 223 on Soil improvers and growing media, and CEN TC 260 on Fertilizers and liming materials.
The following extracts are taken from the BT Resolutions4 on the Market, environment and objectives of these TCs.
| CEN/TC 223-Soil improvers and growing media |
Whilst the work of CEN/TC 223 is not mandated, the standards will assist in compliance with certain EU directives i.e.,
| most transactions in soil improvers and growing media refer to quantity, some being controlled by Council directive 211/76/EEC. |
| WI 00223004 ‘Quantity determination’ was established to produce a method that could be used for all of this type of product and that would enable the quantity declaration made comply with the issues regarding labelling stated in council Resolution 93/C 110/01 in the Annex. |
| The EU Regulatory Committee which prepared Council Regulation (EEC) No. 880/92 of 23 March 1992 on a Community Eco-label award scheme, agreed once CEN/TC 223 methods had been produced on soil improvers and growing media they should be adopted for the purpose of ecolabelling. |
| The EU is considering a Directive on ‘Composting’, which will require standards to support it. A liaison has been established with the EU officer responsible for the development of the directive so those TC 223 standards could be used in support of the directive. |
| CEN/TC 260- Fertilizers and liming materials |
This context is very strong in the field of fertilizers and exchange of information is important between standardisation and regulatory bodies such as Commission's DG Enterprise or national governments. The TC observership fulfils this role with respect to DG Enterprise.
At the present time, DG Enterprise revises the Directives relating to fertilizers and mandates have been given to the CEN by DG Enterprise in order to prepare reports and standards:
| one on organo-mineral fertilizers |
| and another one on chelating agents. |
The future work of DG Enterprise could lead CEN/TC 260 to work on new standards concerning analytical methods for several products in order to apply the directives.
Direct links to the process of elaboration of EC "Fertilizer" directives and an input channel of technical know-how to DG Enterprise.
Furthermore, CEN/TC 260 can help DG Enterprise in future product definition harmonisation.
1.4 Annex IV
Examples of standardisation in EU legislation
Council Directive 67/548/EEC: the many different sources of Standards in chemicals legislation
Council Directive 67/548/EEC was adopted in 1967 and forms the basis of a substantial part of the EU legislation on hazardous chemicals.
The Directive comprises a Directive text, including 32 articles, and includes nine Annexes. The Directive itself is based on Article 95 (100 A), and, as such, can be modified only by the Council and the Parliament. The Annexes may all be modified by a Committee procedure. Changes to these Annexes are made in the form of Commission Directives adapting the Directive to Technical Progress. These Commission Directives are adopted, following a proposal by the Commission to a Technical Progress Committee made up of representatives of the Member States and chaired by a representative of the Commission. Voting on the draft Directive proposal takes place on the basis of the votes allocated to each Member State by Article … of the Treaty. If the proposal receives a favourable opinion from the Committee (i.e. the proposal is adopted by a qualified majority of the Member States), the Commission shall then adopt the draft Directive. Should the proposal not receive a favourable opinion (i.e. a qualified majority is not obtained), the proposal is then submitted to the Council and the Parliament, that then have certain fixed deadlines to respond to the proposal.
The contents of the Annexes, whatever their origin, are thus subject to formal adoption procedures
The Annexes varying in length and scope, some being very extensive. The Annexes relate to the two areas covered by the Directive:
| Classification and Labelling of dangerous Substances and Preparations and |
Annexes I, II, III, IV and VI deal with Classification and Labelling. Annex VI gives detailed criteria for assessing whether substances and preparations should be considered as dangerous, and gives guidance on how these criteria should be applied. In many cases, the test data on which the assessment is based is obtained using the methods described in Annex V.
Annex I lists hazardous substances for which harmonised classification and labelling provisions have been agreed by the EU based on the criteria given in Annex VI.
Annexes II to IV provide information about labelling dangerous substances and preparations. Annex II shows the symbols and indications of danger to be used on the label. Annex III lists the standard phrases indicating the nature of the hazards (the so-called R-phrases), and Annex IV lists the standard phrases (S-phrases) giving advice on safe handling of the dangerous substances and preparations.
Annex IX provides information about packaging of dangerous substances, and includes guidance on child-proof closures and tactile warning devices.
| Notification of New substances |
Annex V, VII and VIII deal primarily with Notification, although Annex V includes information that is also required for Classification and Labelling.
Annexes VII and VIII provide details of the information required for notification of chemicals being put on the European market for the first time. The tests required (normally those listed in Annex V) are in general related to the quantities of chemical placed on the European market.
Annex V includes a large number of test methods for assessing physical chemical, health and environmental hazards of dangerous chemicals. These tests are used when collecting data for the notification of new substances, testing existing substances under Regulation (EEC) 793/93. The results of these tests form to a large extent the basis for the criteria given in Annex VI for classifying substances and preparations as dangerous.
Examples of standards in the Directive
Four of these Annexes make varying and at times extensive use of standards to define the technical requirements of the Directive. More detailed reference to these Annexes are shown at the end of this background document.
The standards used derive from four sources: the UN, the OECD, CEN and ISO.
Symbols have been included in the Directive that have been developed by a UN Committee.
Test methods for establishing the potential hazards of chemicals have been included. These test methods for the most part constitute a transposition into Community legislation of methodology developed by the OECD Test Guidelines programme. Methods to ensure that these tests are carried out appropriately are required by the Directive, which mandates the use of Good laboratory practice, a form of management standard, also developed by the OECD.
Finally, the Directive makes references to a number of EN and ISO standards. Some of these (notably those related to packaging requirements) have been developed under mandate from the Commission. All references to these standards include specific reference both to the standard and to its publication date, so that subsequent revision of the standards by the standards organisation requires explicit confirmation in the legislation.
Annex II
Annex II includes the symbols and indications of danger used on the labels required for dangerous substances and preparations. The symbols are formally part of this Directive. Examples of these symbols are shown below.
These symbols were originally developed in a quite separate organisation which regulates the transport of Dangerous Goods. In 1956, the United Nations Economic and Social Council published the first edition of the UN Recommendations concerning the Transport of Dangerous Goods. The symbols agreed in this context were later adopted for use in the EC legislation on the supply and use of these chemicals. The working of UN CETDG which is responsible for regulating transport of dangerous goods including the preparation of technical standards for testing, packaging and labelling is described elsewhere5.
Annex V
Annex V contains a number of test methods to determine the hazardous properties of substances and preparations. The large majority of these test methods are based on test methods developed by the OECD Test Guidelines programme.
The OECD Guidelines for the Testing of Chemicals are a collection of the most widely used internationally agreed testing methods used by government, industry and independent laboratories to identify and characterise potential hazards of new and existing chemical substances (including biocides and agricultural pesticides) and chemical preparations/mixtures. They cover tests for physical-chemical properties of chemicals, human health effects, environmental effects, as well as degradation and accumulation in the environment.
The Test Guidelines are incorporated into EU legislation by including them in Annex V to Directive 67/548/EEC. As a consequence, the Guidelines have a mandatory position in the requirements for testing of chemicals.
Annex VI
Annex VI gives the general classification and labelling requirements for dangerous substances and preparations. Much of the guidance criteria set out in the Annex are related to the test methods described in Annex V. However there are also references to ISO and CEN standards.
References to standards are included in the criteria as a supplement to the test methods given in Annex V.
Test methods for viscosity as included in the criteria for R65, which relates to mainly organic solvents that can give rise to lung damage if the chemical is aspirated into the lungs.
| R65 | Harmful: may cause lung damage if swallowed Liquid substances and preparations presenting an aspiration hazard in humans because of their low viscosity: |
| (a) | For substances and preparations containing aliphatic, alicyclic and aromatic hydrocarbons in a total concentration equal to or greater than 10 % and having either |
| a flow time of less than 30 sec. in a 3 mm ISO cup according to ISO 2431 (April 1996 / July 1999 edition) relating to ‘Paints and varnishes - Determination of flow time by use of flow cups’, |
| a kinematic viscosity measured by a calibrated glass capillary viscometer in accordance with ISO 3104/3105 of less than 7 x 10-6 m2/sec at 40° C (ISO 3104, 1994 edition, relating to ‘Petroleum products - Transparent and opaque liquids - Determination of kinematic viscosity and calculation of dynamic viscosity’; ISO 3105, 1994 edition, relating to ‘Glass capillary kinematic viscometers - Specifications and operating instructions’), or |
| a kinematic viscosity derived from measurements of rotational viscometry in accordance with ISO 3219 of less than 7 x 10-6 m2/sec at 40° C (ISO 3219, 1993 edition, relating to ‘Plastics – Polymers/resins in the liquid state or as emulsions or dispersions - Determination of viscosity using a rotational viscometer with defined shear rate’). |
Note that substances and preparations meeting these criteria need not be classified if they have a mean surface tension greater than 33mN/m at 25° C as measured by the du Nouy tensiometer or by the test methods shown in Annex V Part A.5.
| (b) | For substances and preparations, based on practical experience in humans. |
Reference to standards is also used in the criteria for calculating the flammability and
oxidising properties of certain gas mixtures.
9. Special cases: preparations
9.1.1. Evaluation of physicochemical properties
9.1.1.1. Flammability
Coefficients of equivalency (Ki)
The values of the coefficients of equivalency Ki, between the inert gases and nitrogen and the values of the maximum contents of flammable gas (Tci) may be found in tables 1 and 2 of the ISO Standard ISO 10156 edition 15. 12. 1990 (new: 1996 edition) relating to ‘Gases and gas mixtures - Determination of fire potential and oxidising ability for the selection of cylinder valve outlets’.
Maximum content of flammable gas (Tci)
The value of the maximum content of flammable gas (Tci) may be found in table 2 of the ISO Standard ISO 10156 edition 15. 12. 1990 (new: 1996 edition) relating to ‘Gases and gas mixtures - Determination of fire potential and oxidising ability for the selection of cylinder valve outlets’.
When a Tci value for a flammable gas does not appear in the above standard, the corresponding lower explosivity limit (LEL) will be used. If no LEL value exists, the value of Tci will be set at 1 % by volume.
9.1.1.2. Oxidising properties
Coefficients of equivalency between oxidising gases and oxygen
The coefficients used in the calculation to determine the oxidising capacity of certain gases in a mixture with respect to the oxidising capacity of oxygen in air, listed under 5.2. in the ISO Standard ISO 10156 edition 15. 12. 1990 (new: 1996 edition) relating to ‘Gases and gas mixtures - Determination of fire potential and oxidising ability for the selection of cylinder valve outlets’, are the following.
| O2 | 1 | |
| N2O | 0,6 |
When no value for the Ci coefficient exists for a gas in the cited standard a value of 40 is attributed to this coefficient.
There are also reference to standards is setting certain labelling requirements. The requirements for substances are shown below; similar provisions not shown here are also given for labelling mixtures of gases (preparations).
8. Special cases: substances
8.1. Mobile gas cylinders
For mobile gas cylinders the requirements concerning labelling are considered to be satisfied when they are in agreement with Article 23 or Article 24 (6) b.
However, by way of derogation from Article 24 (1) and (2), one of the following alternatives can be used for gas cylinders with a water capacity of less than or equal to 150 litres:
| the format and dimensions of the label can follow the prescriptions of the ISO Standard ISO/DP 7225 (1994 edition) relating to ‘Gas cylinders - Precautionary labels’, |
| the information specified in Article 23 (2) may be provided on a durable information disc or label held captive on the cylinder. |
8.2. Gas containers intended for propane, butane or liquefied petroleum gas (LPG)
These substances are classified in Annex I. Although classified in accordance with Article 2, they do not present a danger to human health when they are placed on the market in closed refillable cylinders or in non-refillable cartridges within the scope of EN 417 as fuel gases which are only released for combustion (EN 417, September 1992 edition, relating to ‘Non-refillable metallic gas cartridges for liquefied petroleum gases, with or without a valve, for use with portable appliances; construction, inspection, testing and marking’).
Annex IX
This annex6 describes in detail the provisions related to child-proof fastenings and to tactile warning devices used for packaging dangerous substances and preparations.
Part A
Provisions related to child-proof fastenings
-
Reclosable packages
Child-proof fastenings used on reclosable packages shall comply with ISO standard 8317 (1 July 1989 edition) relating to "Child-resistant packages – Requirements and methods of testing for reclosable packages" adopted by the International Standards Organisation (ISO).
- Non-reclosable packages
Child-proof fastenings used on non-reclosable packages shall comply with CEN standard EN 862 (March 1997 edition) relating to "Packaging - Child-resistant packages – Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products" adopted by the European Committee for Standardisation (CEN).
Notes- Evidence of conformity with the above standards may be certified only by laboratories
which conform with European Standards series EN 45 000.
- Specific cases
If it seems obvious that packaging is sufficiently safe for children because they cannot get access to the contents without help of a tool, the test does not need to be performed.
In all other cases and where there are sufficient grounds for doubting the security of the closure for a child, the national authority may ask the person responsible for putting the product on the market to give it a certificate from a laboratory, described in 3.1,m stating that either:
| the type of closure is such that it is not necessary to test to the ISO or CEN standards referred to above or |
| the closure has been tested and has been found to conform with the standards referred to above. |
Part B
Provisions related to tactile warning devices
The technical specifications for tactile warning devices shall conform with EN ISO standard 11683 (1997 edition) relating to "Packaging – tactile warnings of danger – Requirements".
1.5 Annex VExamples of essential requirements from three selected Directives
| Directive 94/27/EC Packaging and packaging waste |
| Directive 88/378/EEC Safety of Toys |
| Directive 43/23/EEC Low voltage equipment |
Note: Essential requirements from a fourth Directive, Directive 89/392/EEC on the approximation of the laws of the Member States relating to machinery (as amended by Directive 93/44/EEC) are too extensive for this Annex, but can be found online at http://europa.eu.int/eur-lex/en/
Packaging and Packaging Waste Directive: 94/27/EC
Annex II: Essential requirements on the composition and the reusable and recoverable, including recyclable, nature of packing
1. Requirements specific to the manufacturing and composition of packaging
| Packaging shall be so manufactured that the packaging volume and weight be limited to the minimum adequate amount to maintain the necessary level of safety, hygiene and acceptance for the packed product and for the consumer. |
| Packaging shall be designed, produced and commercialized in such a way as to permit its reuse or recovery, including recycling, and to minimize its impact on the environment when packaging waste or residues from packaging waste management operations are disposed of. |
| Packaging shall be so manufactured that the presence of noxious and other hazardous substances and materials as constituents of the packaging material or of any of the packaging components is minimized with regard to their presence in emissions, ash or leachate when packaging or residues from management operations or packaging waste are incinerated or landfilled. |
2. Requirements specific to the reusable nature of packaging
The following requirements must be simultaneously satisfied:
| the physical properties and characteristics of the packaging shall enable a number of trips or rotations in normally predictable conditions of use, |
| possiblity of processing the used packaging in order to meet health and safety requirements for the workforce, |
| fulfil the requirements specific to recoverable packaging when the packaging is no longer reused and thus becomes waste. |
3. Requirements specific to the recoverable nature of packaging
- Packaging recoverable in the form of material recycling
Packaging must be manufactured in such a way as to enable the recycling of a certain percentage by weight of the materials used into the manufacture of marketable products, in compliance with current standards in the Community. The establishment of this percentage may vary, depending on the type of material of which the packaging is composed.
- Packaging recoverable in the form of energy recovery
Packaging waste processed for the purpose of energy recovery shall have a minimum inferior calorific value to allow optimization of energy recovery.
- Packaging recoverable in the form of composting
Packaging waste processed for the purpose of composting shall be of such a biodegradable nature that it should not hinder the separate collection and the composting process or activity into which it is introduced.
- Biodegradable packaging
Biodegradable packaging waste shall be of such a nature that it is capable of undergoing physical, chemical, thermal or biological decomposition such that most of the finished compost ultimately decomposes into carbon dioxide, biomass and water.
Annex II: Essential afety requirements for toys
1.General principles
| 1.1. | In compliance with the requirements of Article 2 of the
Directive, the users of toys as well as third parties must be protected against health
hazards and risk of physical injury when toys are used as intended or in a forseeable way,
bearing in mind the normal behaviour of children. Such risks are those: |
|
| (a) | which are connected with the design, construction or
composition of the toy; |
|
| (b) | which are inherent in the use of the toy and cannot be
completely eliminated by modifying the toy ’s construction and composition without
altering its function or depriving it of its essential properties. |
|
| 1.2 | (a) | The degree of risk present in the use of a toy must be
commensurate with the ability of the users, and where appropriate their supervisors, to
cope with it. This applies in particular to toys which, by virtue of their functions,
dimensions and characteristics, are intended for use by children of under 36 months. |
| (b) | To observe this principle, a minimum age for users of toys
and/or the need to ensure that they are used only under adult supervision must be
specified where appropriate. |
|
| 1.3. | Labels on toys and/or their packaging and the instructions for use which accompany them must draw the attention of users or their supervisors fully and effectively to the risks involved in using them and to the ways of avoiding such risks. |
2. Particular risks
| (a) | Toys and their parts and, in the case of fixed toys, their
anchorages, must have the requisite mechanical strength and, where appropriate, stability
to withstand the stresses to which they are subjected during use without breaking or
becoming liable to distortion at the risk of causing physical injury. |
|||||
| (b) | Accessible edges, protrusions, cords, cables and fastenings
on toys must be so designed and constructed that the risks of physical injury from contact
with them are reduced as far as possible. |
|||||
| (c) | Toys must be so designed and constructed as to minimize the
risk of physical injury which could be caused by the movement of their parts. |
|||||
| (d) | Toys, and their component parts, and any detachable parts of
toys which are clearly intended for use by children under 36 months must be of such
dimensions as to prevent their being swallowed and/or inhaled. |
|||||
| (e) | Toys, and their parts and the packaging in which they are
contained for retail sale must not present risk of strangulation or suffocation. |
|||||
| (f) | Toys intended for use in shallow water which are capable of
carrying or supporting a child on the water must be designed and constructed so as to
reduce as far as possible, taking into account the recommended use of the toy, any risk of
loss of buoyancy of the toy and loss of support afforded to the child. |
|||||
| (g) | Toys which it is possible to get inside and which thereby
constitute an enclosed space for occupants must have a means of exit which the latter can
open easily from the inside. |
|||||
| (h) | Toys conferring mobility on their users must, as far as
possible, incorporate a braking system which is suited to the type of toy and is
commensurate with the kinetic energy developed by it. Such a system must be easy for the
user to operate without risk of ejection or physical injury for the user or for third
parties. |
|||||
| (i) | The form and composition of projectiles and the kinetic
energy they may develop when fired from a toy designed for that purpose must be such that,
taking into account the nature of the toy, there is no unreasonable risk of physical
injury to the user or to third parties. |
|||||
| (j) | Toys containing heating elements must be so constructed as to
ensure that:
|
| (a) | Toys must not constitute a dangerous flammable element in the
child ’s environment. They must therefore be composed of materials which:
|
|||||||||
| (b) | Toys which, for reasons essential to their functioning,
contain dangerous substances or preparations as defined in Council Directive 67/548/EEC7, in particular materials and
equipment for chemistry experiments, model assembly, plastic or ceramic moulding,
enamelling, photography or similar activities, must not contain, as such, substances or
preparations which may become flammable due to the loss of non-flammable volatile
components. |
|||||||||
| (c) | Toys must not be explosive or contain elements or substances
likely to explode when used as specified in Article 2 (1)of the Directive. This provision
does not apply to toy percussion caps, for which reference should be made to point 10 of
Annex I and the related footnote. |
|||||||||
| (d) | Toys and, in particular, chemical games and toys, must not
contain as such substances or preparations:
|
- Toys must be so designed and constructed that, when used as specified in Article 2 (1)of the Directive, they do not present health hazards or risks of physical injury by ingestion, inhalation or contact with the skin, mucous tissues or eyes.
They must in all cases comply with the relevant Community legislation relating to certain categories of products or to the prohibition, restriction of use or labelling of certain dangerous substances and preparations.
- In particular, for the protection of children’s health, bioavailability resulting from the use of toys must not, as an objective, exceed the following levels per day:
0,2 µg for antimony,
0,1 µg for arsenic,
25,0 µg for barium,
0,6 µg for cadmium,
0,3 µg for chromium,
0,7 µg for lead,
0,5 µg for mercury,
5,0 µg for selenium,
or such other values as may be laid down for these or other substances in Community legislation based on scientific evidence. The bioavailability of these substances means the soluble extract having toxicological significance.
- Toys must not contain dangerous substances or preparations within the meaning of Directives 67/548/EEC and 88/379/EEC8 in amounts which may harm the health of children using them. At all events it is strictly forbidden to include, in a toy, dangerous substances or preparations if they are intended to be used as such while the toy is being used.
However, where a limited number of substances or preparations are essential to the functioning of certain toys, in particular materials and equipment for chemistry experiments, model assembly, plastic or ceramic moulding, enamelling, photography or similar activities, they are permitted up to a maximum concentration level to be defined for each substance or preparation by mandate to the European Committee for Standardization (CEN)according to the procedure of the committee set up by Directive 83/189/EEC,provided the permitted substances and preparations comply with the Community classification rules in respect of labelling, without prejudice to point 4 of Annex IV.
2.4. Electrical properties| (a) | Electric toys must not be powered by electricity of a nominal
voltage exceeding 24 volts and no part of the toy may exceed 24 volts. |
|
| (b) | Parts of toys which are connected to, or liable to come into
contact with a source of electricity capable of causing electric shock, together with the
cables or other conductors through which electricity is conveyed to such parts ,must be
properly insulated and mechanically protected so as to prevent the risk of such shock. |
|
| (c) | Electric toys must be so designed and constructed as to ensure that the maximum temperatures reached by all directly accessible surfaces are not such as to cause burns when touched. |
Toys must be so designed and manufactured as to meet the requirements of hygiene and cleanliness in order to avoid any risk of infection, sickness and contamination.
2.6. RadioactivityToys must not contain radioactive elements or substances in forms or proportions likely to be detrimental to a child’s health. Council Directive 80/836/ Euratom shall apply9.
1.5.2 Low Voltage equipment Directive 73/23/EECAnnex I: Principal elements of the safrty objectives for electrical equipment designed for use within certain voltage limits
1. General conditions
- The essential characteristics, the recognition and observance of which will ensure that
electrical equipment will be used safely and in applications for which it was made, shall
be marked on the equipment, or, if this is not possible, on an accompanying notice.
- The manufacturers or brand name or trade mark should be clearly printed on the
electrical equipment or, where that is not possible, on the packaging.
- The electrical equipment, together with its component parts should be made in such a way
as to ensure that it can be safely and properly assembled and connected.
- The electrical equipment should be so designed and manufactured as to ensure that protection against the hazards set out in points 2 and 3 of this Annex is assured providing that the equipment is used in applications for which it was made and is adequately maintained.
2. Protection against hazards arising from the electrical equipment
Measures of a technical nature should be prescribed in accordance with point 1,in order to ensure:
- that persons and domestic animals are adequately protected against danger of physical
injury or other harm which might be caused by electrical contact direct or indirect;
- that temperatures, arcs or radiation which would cause a danger, are not produced;
- that persons, domestic animals and property are adequately protected against
non-electrical dangers caused by the electrical equipment which are revealed by
experience;
- that the insulation must be suitable for foreseeable conditions.
3. Protection against hazards which may be caused by external influences on the electrical equipment
Technical measures are to be laid down in accordance with point 1,in order to ensure:
- that the electrical equipment meets the expected mechanical requirements in such a way
that persons, domestic animals and property are not endangered;
- that the electrical equipment shall be resistant to non-mechanical influences in
expected environmental conditions, in such a way that persons, domestic animals and
property are not endangered;
- that the electrical equipment shall not endanger persons, domestic animals and property in foreseeable conditions of overload.
| 1 | Updated version of Annex 1 in "Guide to the
implementation of directives based on the New Approach and the Global Approach. |
| 2 | Personal communication, Claus Jensen, based on CEN reporting
to 98/34 Committee. |
| 3 | Personal communication, Claus Jensen, based on CEN reporting
to 98/34 Committee. |
| 4 | As posted on the CEN SABE (Strategic Advisory Body for the
Environment) website. Note that some of these resolutions refer to measures that have
since been adopted. |
| 5 | See paper on "Government Standardisation". |
| 6 | OJ L136 8.6.2000, p. 89 |
| 7 | OJ No 196,16.8.1967, pp.1-67. |
| 8 | OJ No L 187,16.7.1988, p.14. |
| 9 | OJ No L 246,17.9.1980,p.1. |