Eurofins | Newsflash - January 2019 | Toys & Childcare
New phthalates restriction and scope expansion under REACH Annex XVII (Entry 51)
On 18th December 2018, Commission Regulation (EU) 2018/2005 was published in the Official Journal of the European Union.
This new regulation amends Entry 51 of Annex XVII to REACH Regulation (EC) No 1907/2006 as regards bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP) and diisobutyl phthalate (DIBP).
Previously, only three phthalates (DEHP, DBP, BBP) were restricted in plasticised materials in toys and childcare articles under this Entry 51.
The new amendment introduces the following 2 major changes:
- Inclusion of Diisobutyl phthalate (DIBP) restriction, in addition to DEHP, DBP and BBP, in toys and childcare articles
- Scope expansion: not only toys and childcare articles are included in the scope of the restriction of these 4 phthalates (DEHP, DBP, BBP, DIBP), but also any plasticised materials in articles. List of articles excluded from this restriction is included in Paragraph 4 of this new amended Entry 51, within which we can find:
- Measuring devices for laboratory use
- Materials and articles intended to come into contact with food within the scope of Regulation (EC) No 1935/2004 or Commission Regulation (EU) No 10/2011
- Medical Devices
- Electrical and electronic equipment within the scope of RoHS Directive 2011/65/EU
As indicated in the new Entry: ‘Plasticised material’ means any of the following homogeneous materials:
- Polyvinyl chloride (PVC), polyvinylidene chloride (PVDC),polyvinyl acetate (PVA), polyurethanes
- Any other polymer (including, inter alia, polymer foams and rubber material) except silicone rubber and natural latex coatings
- Surface coatings, non-slip coatings, finishes, decals, printed designs
- Adhesives, sealants, paints and inks
These additional restrictions under REACH Annex XVII Entry 51 will become effective from 7 July 2020.
Toy Safety Directive - New amendment Drafts regarding Aluminium and Formaldehyde
The following draft texts have been recently notified to World Trade Organization (WTO) by the European Commission regarding amendments to Toy Safety Directive:
Reference |
Date |
Title |
10/12/2018 |
Draft Commission Directive amending, for the purposes of adaptation to technical and scientific developments, point 13 of part III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards aluminium. This Draft lowers the migration limits for aluminium as below:
|
|
18/12/2018 |
Draft Commission Directive amending Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council for the purpose of adopting specific limit values for chemicals used in certain toys, as regards formaldehyde. This draft Commission Directive aims to include, in Appendix C to Annex II to Directive 2009/48/EC, limit values for formaldehyde in polymeric toy material, resin-bonded wood toy material, textile toy material, leather toy material, paper toy material and water-based toy material. Proposed limit values for formaldehyde:
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Excessive levels of phthalates in toys
Every week European alerts about Phthalates in toys and other children’s products are published in RAPEX (Rapid Alert System for dangerous non-food products).
A joint customs and market surveillance operation by different EU countries took place during the last quarter of 2018. The inspections focused on plasticized toys (especially dolls).
The result was quite worrying: more than a third of inspected samples with CE marking in their packaging contained phthalates in concentrations exceeding the limits under REACH Annex XVII Entry 51 and 52.
Click here for watching the European Commission conference on REACH, CLP and biocides.
Standards Updates
Below a summary table with some recent standards updates and upcoming dates of withdrawal (non-exhaustive):
(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.
Reference |
Title |
Date of Withdrawal (*) |
Supersedes |
Child care articles - Bathing aids - Safety requirements and test methods. |
2019-05-31 |
- |
Practical guides for toys and childcare
Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes (DGCCRF) has published several guides about toys and childcare articles as below (in French):
Oregon Amends the PQLs for Chemicals of Concern list
On 7th December 2018, Oregon Health Authority (OHA) approved a Permanent Administrative Order PH 280-2018 amending the Practical Quantification Limits (PQLs) for High Priority Chemicals of Concern for Children's Health (HPCCCH) under Toxic-Free Kids Act.
Under the Toxic-Free Kids Act, manufacturers must provide biennial notice to OHA of children's products sold in Oregon that are covered by the Oregon Toxic-Free Kids Act and contain HPCCCH in the final product that are intentionally added at or above practical quantification limits (PQL).
The PQL for a chemical that is a contaminant is 100 parts per million. The practical quantification limits for intentionally added chemicals are the limits established in Exhibit A.
The new Administrative Order PH 280-2018 amends OAR 333-016-2035 Exhibit A by adding PQLs corresponding to the five HPCCCH added to OAR 333-016-2020 on September 2018, and removing PQLs for the three HPCCCH delisted also on September 2018. (Check our Eurofins News Flash November 2018 edition for further information on the September 2018 rulemaking mentioned above).
This amendment is effective from January 1, 2019. Click here for more details.
Flame Retardant Bill on Juvenile Products, Upholstered furniture and mattresses – Enacted!
On 29th September 2018, California’s flame retardant Bill AB 2998 was approved by Governor and, therefore, already enacted.
From January 1, 2020, it is prohibited to sell or distribute in California any new juvenile products, mattresses, or upholstered furniture containing covered flame retardant chemicals or a constituent component at levels above 1,000 parts per million.
Covered flame retardant chemicals means any chemical whose functional use is to resist or inhibit the spread of fire including one of the following:
- A halogenated, organophosphorus, organonitrogen, or nanoscale chemical
- A chemical defined as a “designated chemical” in Section 105440 of the Health and Safety Code
- A chemical covered in the Washington’s list of Chemicals of High Concern to Children
“Juvenile product” means a product designed for residential use by infants and children under 12 years of age, including, but not limited to, a bassinet, booster seat, changing pad, floor playmat, highchair, highchair pad, infant bouncer, infant carrier, infant seat, infant swing, infant walker, nursing pad, nursing pillow, playpen side pad, playard, portable hook-on chair, stroller, and children’s nap mat. Some products not included in “Juvenile product” definition are listed in the Bill.
The prohibitions in this ban do not apply to the following:
- Electronic components of juvenile products, mattresses, reupholstered furniture, upholstered furniture, or any associated casing for those electronic components
- Upholstered or reupholstered furniture components other than those identified in paragraph (1) of subdivision (a) of Section 19094
- Thread or fiber when used for stitching mattress components together
- Components of adult mattresses other than foam
The text of Assembly Bill No. 2998 (AB 2998) can be found here.
Ontario’s Upholstered and Stuffed Articles Regulation Abolished
On December 6, 2018 the Government of Ontario approved the revocation of the Upholstered and Stuffed Articles Regulation (O. Reg. 218/01) under the Technical Standards and Safety Act, 2000(TSSA).
From July 1, 2019, manufacturers, renovators, home hobby/craft operators and other persons currently related to this regulation in the Province of Ontario are not required to comply with all Ontario-specific requirements including provincial licensing, labelling, processing, cleanliness and sterilization requirements under the regulation.
However upholstered and stuffed articles sold in Ontario will still have to comply with all applicable federal legislation such as the Canada Consumer Product Safety Act and the Textile Labelling Act.
Be noted that this revocation applies only in Ontario: upholstered and stuffed articles regulations in the provinces of Manitoba and Quebec are still in force.
This revocation will come into effect July 1, 2019. TSSA will keep on administering and enforcing the regulation during the transitional period.
Public consultation on safety standards for toys and children’s products
On 1st December 2018, a one-month public consultation on proposed updates to safety standards for toys and for five categories of children’s products (under Hong Kong’s Toys and Children’s Safety Ordinance (Cap. 424 ) was launched by the Hong Kong Government.
Below a summary table:
Product |
Updated Proposal |
Current |
Toy |
ISO 8124-1:2018 |
ISO 8124-1:2014 |
ISO 8124-4:2014/ A1:2017 |
ISO 8124-4:2014 |
|
BS EN 71-3+A3:2018 |
BS EN 71-3:2013+A1:2014 |
|
BS EN 71-7:2014+A2:2018 |
BS EN 71-7:2014 |
|
BS EN 71-8:2018 |
BS EN 71-8:2011 |
|
BS EN 71-14:2014+A1:2017 |
BS EN 71-14:2014 |
|
Child safety barriers for domestic use |
ASTM F1004-18 |
ASTM F1004-16b |
Children’s cots for domestic use |
BS EN 716-1:2017 |
BS EN 716-1:2008+A1:2013 |
BS EN 716-2:2017 |
BS EN 716-2:2008+A1:2013 |
|
Children’s high chairs and multi-purpose high chairs for domestic use |
ASTM F404-18 |
ASTM F404-17 |
BS EN 14988:2017 |
BS EN 14988-1:2006 +A1:2012 and BS EN 14988-2:2006 +A1:2012 |
|
Children’s paints |
BS EN 71-3:2013+A3:2018 |
BS EN 71-3:2013+A1:2014 |
Playpens for domestic use |
ASTM F406-17 |
ASTM F406-15 |
Click here for reading the proposal from Hong Kong’s Government website.
Standards that will start applying within the next six months (non-exhaustive)
EUROPE |
||
Standard Reference |
Title Standard |
Date of withdrawal (*) |
EN 71-1:2014 + A1:2018 |
Safety of toys - Part 1: Mechanical and physical properties |
2019/02/28 |
EN 71-3:2013+A3:2018 |
Safety of toys - Part 3: Migration of certain elements |
2019/02/28 |
EN 71-7:2014+ A2:2018 |
Safety of toys - Part 7: Finger paints - Requirements and test methods |
2019/02/28 |
EN 71-8:2018 |
Safety of toys - Part 8: Activity toys for domestic use |
2019/02/28 |
EN 71-14:2014+A1:2017 |
Safety of toys - Part 14: Trampolines for domestic use |
2019/02/28 |
(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.
Legislations that will start applying within the next six months (non-exhaustive)
US |
||
Legislation |
Starts Applying Date |
Comments |
Washington D.C. Law- Title 8, Chapter 1, Subchapter IV.A-§ 8–108.02a. Prohibitions on chlorinated flame retardants. |
2019/01/01 |
Applicable to any product containing more than 0.1% by mass of TDCPP, TCEP. |
40 CFR 770- Formaldehyde Standards for Composite Wood Products ; Title VI of Toxic Substances Control Act (TSCA). |
2019/03/22 |
Beginning on March 22, 2019, composite wood products must be labeled as TSCA Title VI compliant. These products include: hardwood plywood, medium-density fiberboard, and particleboard, as well as household and other finished goods containing these products. |
CANADA |
||
Legislation |
Starts Applying Date |
Comments |
Prohibition of Asbestos and Products Containing Asbestos Regulations (SOR/2018-196). |
2018/12/30 |
|
Below you will find a monthly summary of product recalls and alerts in Europe (Source “RAPEX”) and in the US (Source “CPSC”).
Europe
RAPEX (European Commission Rapid Alert System for dangerous non-food products – Alerts reported by EU national authorities).
The following 66 alerts regarding Childcare articles, equipment and toys have been reported, from week 47 until week 50 of 2018.
Type of Risk |
Number of alerts |
Notes |
Burns |
1 |
Fancy-dress mask: highly flammable and does not self-extinguish in the event that it is ignited by a flame. Not complying with EN 71-2. |
Chemical |
22 |
Phthalates: 2-ethylhexyl phthalate (DEHP), dibutyl phthalate (DBP), diisobutyl phthalate (DIBP) - (77% of samples with phthalates are dolls). |
Balloons: nitrosamines, nitrosatable substances. |
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Toy slime and clay: high level of migration of Boron. |
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Button cell batteries: easily accessible. Not complying with Toy Safety Directive and standard EN 62115. |
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Solder: contain cadmium and lead. Not comply with RoHS 2 Directive. |
||
Choking |
34 |
Small parts. Not complying with EN 71-1. |
Suction cups of projectiles can easily detach. Not complying with EN 71-1. |
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Babies’ sleeping bags: the zipper puller easily detaches. |
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Entrapment |
3 |
Ride-on toys: Children’s fingers entrapment between moving elements. Not complying with EN 71-1. |
Damage to hearing |
1 |
Musical toy: the sound pressure level of the toy is too high. Not complying with EN 71-1. |
Injuries |
5 |
Toy cars with launcher: Kinetic energy too high. |
Toy Pushchair: one safety lock, is not sufficiently resistant to load and can easily collapse. Not complying with EN 71-1. |
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Toy baby-walker and Toy highchair: locking device does not work properly. Not complying with EN 71-1. |
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Baby walker (childcare article): the strength of the baby walker is inadequate and there is no proper protection to prevent it from falling down steps. Not complying with EN 1273. |
From 21st November to 20th December 2018, CPSC (Consumer Product Safety Commission) has published the following recalls: 2 recalls regarding Childcare and children’s products.
Type of Risk |
Number of recalls |
Notes |
Choking |
1 |
Children’s soft books: A metal grommet used to attach a fabric flap to a page in the book can detach. |
Fall and injury |
1 |
Children’s high chair: the legs on the highchair can detach from the seat, posing fall and injury hazards to children. |