Repealed Directive – TSD 88/378/EEC

The general provisions of TSD 2009/48/EC are applicable to toys placed on the market as of 20 July 2011. However, TSD 88/378/EEC remains applicable to toys placed on the market before this date. During the transitional period of TSD 2009/48/EC, chemical requirements under TSD 88/378 remain applicable to toys placed on the market as before 20 July 2013 as well. Directive 88/378/EEC was initially adopted in the context of the achievement of the internal market in order to avoid barriers to trade originated by different safety provisions applied by Member States. The Directive also had the aim to reach a high level of toy safety in the Community. However, the technological developments in the toys market raised new issues regarding the safety of toys. The new Directive answers to the need of updating the existing safety requirements of providing a more coherent approach in the implementation of market surveillance. TSD 88/378/EEC defined as a toy: “any product or material designed or clearly intended for use in play by children of less than 14 years of age”. The scope is now broader in Directive 2009/48/EC, which applies to toys defined as "products designed or intended, whether or not exclusively, for use in play by children under 14 years of age". However, apart from differences in scope further comparisons between TSD 88/378/EEC and TSD 2009/48/EC can be done:

TSD 2009/48/EC establishes stricter obligations to the importer and to the distributor:

Importer: can only place compliant toys on the EU market and needs to ensure that Manufacturer has drawn up the technical documentation; has to ensure that the products bear the CE mark and that the importer’s name and address is indicated;
Distributors: must act with due care, while ensuring the presence of the CE mark and of the required documentation.

Enhanced safety requirements:

In case a risk is not covered by any particular safety requirement:

TSD 88/378/EEC - “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 foreseeable way, bearing in mind the normal behavior of children”;
TSD 2009/48/EC - “Toys shall not jeopardize the health or safety of users or third parties when they are used as intended or in a foreseeable way, bearing in mind behavior of children.”

Physical and Mechanical Properties – Toys must not present the following risks:

Choking risks

TSD 88/378/EEC - Toys for children under 36 months;
TSD 2009/48/EC - Extended to other toys which are intended to be put in the mouth.

Suffocation Risk

TSD 88/378/EEC – As a result of external airway obstruction of mouth and nose;
TSD 2009/48/EC – As a result of internal airway obstruction.

Toys in food

TSD 88/378/EEC - No references;
TSD 2009/48/EC – a) Toys contained within food or co-mingled with food must have their own packaging. This packaging must be of such dimensions as to prevent its being swallowed and/or inhaled; b) Toys contained in food or co-mingled with food shall bear the following warning: “Toy inside. Adult supervision recommended”; c) Toys firmly attached to a food product at the moment of consumption, in such a way that the food product needs to be consumed in order to get direct access to the toy, shall be prohibited (this is the case of some lollypops).

Chemical Properties

TSD 88/378/EEC

Toys must present no health hazard or risk of physical injury by ingestion, inhalation or contact with the skin, mucous tissues or eyes;
Toys must comply with the relevant Community legislation relating to certain categories of products or to the prohibition, restriction of use or labeling of certain dangerous substances and preparations;
Definition of maximum levels for cadmium, chromium, lead, mercury, selenium.

TSD 2009/48/EC

Toys must present no risks of adverse effects on human health due to exposure to the chemical substances or preparations of which toys are composed or which they contain;
Compliance with the relevant Community legislation relating to certain categories of products or to the prohibition, restriction of use or labeling of certain dangerous substances and preparations, including REACH (Regulation 1907/2006);
Inclusion of three different sets of rules especially for toys:

Prohibition of CMR (with the possibility of exemptions);
Ban of 38 allergenic fragrances; traces allowed if unavoidable in good manufacturing practice;
Stricter limits for certain heavy metals.

Electrical Properties

TSD 88/378/EEC

Toys must not be powered by electricity exceeding 24 Volts;
If risk of electrical shock, proper insulation and mechanically protection;
Maximum temperatures of exposure may not cause burns.

TSD 2009/48/EC – In addition:

Toys must provide protection against electrical hazards arising from an electrical power source, against fire hazards;

Toys must present no health hazards or risk of injury to eyes or skin from lasers, LED or any other type of radiation.

Hygiene

TSD 88/378/EEC

Toys must meet the requirements of hygiene and cleanliness in order to avoid any risk of infection, sickness and contamination.

TSD 2009/48/EC

Extension of the above with “Textile toys for children under 36 months shall be washable and need to fulfill the Environmental and Safety Requirements also after washing.

Warnings

TSD 88/378/EEC

Visible and clearly legible warnings.

TSD 2009/48/EC

Extension of the above with warning must specify if appropriate: a) user limitations; b) ability of the user; c) minimum or maximum weight; d) adult supervision.

Conformity Assessment Procedures

TSD 88/378/EEC

Self verification if - harmonized standard covering all safety aspects are complied with;
Third party verification (EC type examination) if: a) harmonized standards do not exist (i.e. magnets); b) harmonized standards are not complied with completely; c) manufacturers consider that toy necessitates third party verification.