EU Directive on the Safety of Toys

1. EU Directive on the Safety of Toys Mark DewarICPHSO Seoul 1st November 2011

2. Is a toy not a toy when inflated by an under 8 balloonist? • Questioning your existence – but only in this room. What am I doing here? • Follow the instructions: Open and blow. • What is a toy? • What am I? • Does it matter? • What is the TSDR (‘ToySDirRe’)? • How does it dovetail with other legislation/regulation eg ASTM, ISO • Why should I care?

3. Statistics (2010) Notifying Countries Countries of Origin

4. Statistics (2010) Product Categories Types of Risks (Top five categories)

5. Welcome to ToySDirRe • Changes replaces and builds on 20 year old directive • New Approach Directive • Principles – essential safety requirements – Article 10 and Annex II • Underpinned by harmonised standards that stipulate technical requirements • Part of interlocking EU regulatory regime • Approximation of laws of member states concerning safety of toys becomes safety of toys. • What is toy? Definition refined by amendment to exclusion ( Annex 1) • Products designed or intended, whether or not exclusively, for use in play by children of less than 14 years of age

6. Welcome to ToySDirReContext/Reminder: Key changes introduced by TSD • Depends on your perspective. Testing lab may say: • EC declaration on conformity –drawn up by manufacturer • Safety assessment/risk assessment • Carried out by manufacturer – id hazards • Keep in technical documentation • Product control – more specific internal, self verification and monitoring • New Chemical requirements 20 July 2013 • New mechanical requirments for toys with food.

7. To improve the enforcement and efficiency of the Directive Economic Operator Responsibilities Changes to technical file contents To improve safety requirement of toys Clarifying criteria of essential safety requriements Enhanced warning requirements Choking risk Suffocation risk Special requirements for toys in food New Chemical Requirements Welcome to ToySDirReContext/Reminder: Key changes introduced by TSD

8. Implementation • 20th July 2011 – Implement but not Chemicals • Develop revised harmonised standards • 20th July 2013 – implement chemical requriements • Develop revised chemical standards • 20th July 2017 -Develop special requirements for food grade materials

9. EN 71-1:Standard formechanicaland physical properties EN 71-2 Flammability New Approach Directive ToySDirRe 2013 EN for Chemicals EN 71-8Active Toysfor domesticuse EN 62115 Electrical Toys

11. Conformity Assessment Procedures Based on criteria on directive – purchase, design, brand and stage in cycle May not be what expected May be different for same company depending on role Different obligations depending on role. Upstream ( manufacturer more onerous than importer) Economic Operators – refinement to place on market Manufacturers Importers Distributors Authorised Representatives (Manuf only) Technical Documentation – manufacturers need to know what in materials and substances in toy Design and manufacture- components -,safety data sheet on chemicals from chemical suppliers Safety/risk assessment before toy placed on market Conformity assessment procedure EC declaration of conformity signed by senior officer of company To improve the enforcement and efficiency of the Directive

12. To improve the enforcement and efficiency of the Directive Traceability Surveillance authorities to trace toys through supply chain by • Include colour image of sufficient clarity to enable identification of the Toy in Declaration of Conformity or Tech Doc • Ensure traceability throughout supply chain

13. To improve safety requirement of Toys Clarify Essential Safety Requirements – update to reflect technical change Stronger limits on noise – impulse and prolionged Permit exceed 24v and maintain safety level. Chemical Requirements Extend migration limits for heavy elements from 8 to 19 (2013) Chemical requirements update to cover allergenic and CMRs – take a/c of REACH and other legislation Fragrances 55 banned subject to trace of up to 100ppm where unavoidable in GMP More than cosmetics requirements – sourcing issue 11 allergenic substances permitted but label needed if >0.01% weight Exemptions apply for certain games and cosmetic kits Nitrosamines and nitrosable substances are banned in toys for <3yrs and all mouthable toys if migration .05mg/kg for nitrosamines and 1mg for nitrosable

14. Warnings and marking Primarily manufacture duty but importer has to show name and address on the product. Other Economic Operators have to show has been done. • NB • CE marking fixed visibly, legibly and indelibly to the toy or an affixed label – small toys to label/leaflet or counter • If not visible from outside packaging then on packaging • ToySDirRe more explicit re warnings: • EN 71-1 comprehensive list of prescriptive warnings • ‘Warning’ needs to precede statement • At point of sale if determine decision to purchase • In food, own label: ‘Contains a toy, adult supervision recommended’ – cannot be a small part choking hazard • Must be in one or more languages easily understood by consumers as required by Member State

15. Choking and suffocation risk – changes • Toys and detachable parts mustn’t present risk asphyxiation by blocking mouth and nose, nor block off airways if wedged in mouth • Toys for < 36 months, or placed in mouth – must not be small part that can be swallowed or inhaled • Retail packaging must not present a risk of strangulation or asphyxiation by blockage to mouth and nose – esp egg shaped, spherical • Special requirements for toys with food • Prior toys coupled with foodstuffs in a way that prior consumption of food item is necessary to access toy- • Toys in food or mingled with food must have own packaging • Packaging should not present choking hazard

16. The answer: The Telegraph 9th October 2011 ‘EU toy safety directive states that balloons must not be blown up by unsupervised children under the age of 8 in case they accidentally choke’ Daily Mail 10th October 2011 ‘Under the rules children under the age of 8 are no longer allowed to blow up balloons, if they are unsupervised’ Westender Brisbane Australia ‘EU have passed new toy safety laws….according to new directives, children under the age of 8 will no longer be able to blow up balloons’ • No : since 1998 balloons made of latex carry a warning that recommends adult supervision. It does not prevent children under the age of 8 from blowing up balloons • What is says: “Warning! Children under eight years can choke or suffocate on uninflated or broken balloons. Adult supervision required. Keep uniflated balloons from children. Discard broken balloons at once.’

17. What next? • More harmonised standards, increasing specificity • Greater co-ordination the length and breadth of supply chain • Market surveillance enhanced under EU 765/2008 – fewer places for non-compliants to hide • Increased cost of regulatory compliance – even EN 71-1 cost £261 • Multijurisdictional issues – ISO, ASTM ToySDiRe • Multilingual issues – even EU needs warnings for same product in possibly 23 languages • Greater barriers to new market entrants – will the big players share their know how with those less able to afford it?

18. simmons-simmons.com elexica.com