The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).
Toys and Children's Products
Toys play a significant role in the mental development of children across the world while also making a large contribution to the economy.
The internal market for toys in the EU worth approximately €4.2 billion. The EU has some of the strictest standards for toy products – particularly concerning chemicals.
EU Legislation on Toys
Until the publication of the Toy Safety Directive 2009/48/EC on June 18, 2009 and the subsequent 2 year transition period, the Toy Safety Directive 88/378/EEC was the reigning legal framework for toy products. From July 20, 2011, the Toy Safety Directive 2009/48/EC became fully applicable in the EU as the main legal framework for toys.
Today, any product to made available in the EU Market (either through e-commerce or brick-and-mortar) must comply with the Toy Safety Directive.
Non-EU manufacturers wishing to make their products available to EU citizens must appoint an Authorized Representative. (A manufacturer is defined as any natural or legal person who manufactures a toy or has a toy designed or manufactured, and markets that toy under his name or trademark.)
Products which fail to comply may be subject to public notification (RAPEX), withdrawal requirements, warehousing fees, fines or total destruction of the product(s).
The European Parliament and Council Directive 2009/48/EC on the safety of toys (“TSD” – Toy Safety Directive) was published on 30 June 2009 and entered into force on 20 July 2009 aimed to entirely repeal the TSD 88/378/EEC (Toy Safety Directive), Council Directive 88/378/EEC of March 3, 1988 which was published on January 1, 1990.
The general provisions are applicable to toys placed on the market as of 20 July 2011, while chemical provisions have been applicable to toys placed on the market as of 20 July 2013. During this transitional period, part III of annex II – chemical requirements – of Directive 88/378/EEC still continue to apply.
The two main objectives of Directive 2009/48/EC are first to ensure that the safety of toy users (children under 14 years of age) is harmonized at a European level in the sense that the essential requirements are to be met at the manufacturing stage and secondly to guarantee the good functioning of the internal European market for toys. The standards laid down by the European standardization bodies provide evidence of conformity with the essential requirements of the Directive. Toys that meet these requirements bear the CE marking.
As an example, the repealing Directive 2009/48/EC limits the amounts of certain chemicals that may be contained in materials used for toys. In this context CMR (Carcinogenic, Mutagenic or toxic for Reproduction) substances, are no longer allowed in accessible parts of toys. For certain substances like nickel, tolerable limit values have been introduced and certain heavy metals which are particularly toxic, like lead, may no longer be intentionally used in those parts of toys that are accessible to children.
Directive 2009/48/EC applies to toys defined as “products designed or intended, whether or not exclusively, for use in play by children under 14 years of age”. In order to adjust to the current practices of toy manufacturers, the new element of TSD 2009/48/EC is in the wording “whether or not exclusively” of the definition, which indicates that a product does not have to be exclusively intended for playing purposes to be considered a toy. Therefore, products with double functions are also considered as toys. Notwithstanding, the following toys are not included in the scope of TSD 2009/48/EC
- Playground equipment intended for public use;
- Automatic playing machines, whether coin operated or not, intended for public use;
- Toy vehicles equipped with combustion engines;
- Toy steam engines;
- Slings and catapults.
Annex I of the TSD also presents a non-exhaustive list of products that are not considered as toys but that could originate confusions, and in which case, other EU Directives such as GPSD (2001/95/EC), MSD (98/37/EC), R&TTE (1999/5/EC), EMC (2004/108/EC) and LVD (2006/95/EC) may be applicable. This is the case for:
- Decorative objects for festivities and celebrations;
- Products for collectors, when intended for collectors of 14 years of age and above;
- Sports equipment intended for children with a body mass of more than 20 kg;
- Bicycles with a maximum saddle height of more than 435 mm;
- Scooters and other means of transport intended to be used for travel on public roads or public pathways;
- Electrically driven vehicles intended to be used for travel on public roads, public pathways, or pavement;
- Aquatic equipment intended to be used in deep water, and swimming learning devices for children;
- Puzzles with more than 500 pieces;
- Guns and pistols using compressed gas;
- Products and games using sharp-pointed missiles;
- Functional educational products operated at a nominal voltage exceeding 24 volts which are sold exclusively for teaching purposes under adult supervision;
- Products intended for use for educational purposes in schools and other pedagogical contexts under the surveillance of an adult instructor;
- Electronic equipment, such as personal computers and game consoles;
- Interactive software, intended for leisure and entertainment, such as computer games, and their storage media;
- Babies’ soothers;
- Child-appealing luminaries;
- Electrical transformers for toys;
- Fashion accessories for children not for use in play.
Only toys meeting the essential requirements of TSD 2009/48/EC may be placed in the EEA market and entitled to free movement throughout all Member States. In particular, standards laid down by the European standardization bodies provide evidence of compliance with the essential requirements – toys meeting these requirements bear the CE marking.
When a toy is placed on the EEA market, the manufacturer must draw up an EC declaration of conformity, which must be kept by the manufacturer, or its Authorized Representative established within the EU for a period of 10 years after the toy is put on the market and continuously updated if necessary. By doing so, the manufacturer assumes the responsibility for the compliance of the toy with the essential requirements of the TSD 2009/48/EC.
Each toy to be placed on the market is subject to a conformity assessment procedure, which demonstrates that a toy placed on the market complies with the requirements of TSD 2009/48/EC. The manufacturer is required to apply one of two possible procedures depending on the nature of the toy:
- Self verification: used in cases where harmonized standards cover all relevant aspects of a toy. In this case, the manufacturer must apply the existing harmonized standards and ensure that the toy is in conformity. The manufacturer must also put in place an internal production procedure in accordance with Module A of Annex II of Decision 768/2008/EC, for which the involvement of a notified body is not required. However, many large retailers still require an independent report as a condition of supply, even though this is not a legal requirement.
- Third party verification / “EC-type examination”: it is required in case harmonized standards do not exist; harmonized standards have not or only partly been applied by a manufacturer; one or more harmonized standards have been published with a restriction; or the manufacturer considers that the nature, design, construction or purpose of the toy requires a third-party verification.
In such cases, under Module B of Annex II to Decision 768/2008/EC, the manufacturer submits a model of the toy to a Notified Body which examines the technical design of a toy and verifies and attests that the toy meets the requirements of TSD 2009/48/EC by issuing an EC-type examination certificate. Under Module C, which covers the production phase, the manufacturer ensures the conformity of the toys with the type described in the EC-type examination certificate and with the relevant requirements. Conformity under Module C is evaluated against an approved EC-type examination certificate and does not require the involvement of a notified body.
However, before submitting the toy to the appropriate conformity assessment and before the toy is placed on the market, the manufacturer must draw up a safety assessment, which has the objective of identifying the potential hazards of a toy and to assess the potential exposure to those hazards – this procedure is mandatory under TSD 2009/48/EC and will determine which conformity assessment procedure is required.
The safety assessment must cover the various chemical, physical, mechanical, electrical, flammability, hygienic and radioactivity hazards that the toy may present, as listed in Annex II of TSD 2009/48/EC. Even though many of these requirements are covered by harmonized standards, the manufacturer must assess whether there may be gaps uncovered.
The safety assessment must be kept as well by the manufacturer in the technical documentation for 10 years after the toy has been placed on the market.
Evidently, non-compliant products enter the EU Market everyday – whether the brand owner knowingly does so or due to a lack of knowledge imparted from EU importers/distributors. As there is no “approval” in the EU Market, Competent Authorities focus almost exclusively on conducting systematic surveillance of products which are being made available on the market. This can include pulling products off of shelves, stopping products at customs or even deploying bots online to identify non-EU based e-commerce shops which mention that they ship to the EU Market.
Should you choose to take the risk to ship product to Europe which has not followed the required path to compliance as detailed above, you should also be prepared for the consequences. The main consequences include, but are not limited to:
- Being publicly reported to the RAPEX,
- Warehousing Fees,
- Requested Withdrawal,
- Mandated Withdrawal,
- Product Recall (from end-users and/or the market),
- Complete ban on marketing of the product,
- Destruction of the product,
- Revocation of the CE Marking.
Ultimately, the prescribed actions that are to be taken in the case that a product is found to be non-compliant will vary depending on the EU Competent Authority which identified the breach, the EU Member State, cooperation from the brand owner and the actions taken by the appointed Authorized Representative. Above all else, the professionalism and expertise of the appointed Authorized Representative in dealing with various Competent Authorities and handling such situations play a vital role in the successful recovery of your brand in the EU Market.
It is the responsibility of each brand owner to continue to collect information related to use of their products after they have been made available to consumers as well as to ensure that they continue to comply as the legislation applicable to their products evolves. Post-marketing surveillance activities include, but are not limited to:
- Staying up-to-date on new requirements or legislative changes,
- Continual updating of the technical file as modifications are made to the product,
- Reporting of any incidents related to the product use,
- Removal of non-compliant batches from EU economics operators and end-user,
- Keeping technical file available for 10 years after the last batch entered the EU market.
Working with a professional Authorised Representative will help to ensure that the necessary actions are taken to ensure continued compliance and proper post-market surveillance.