The scope of the restrictions on phthalates has also been expanded to cover all types of products to be sold in the EU.
The updates were announced in March 2018 with a notification to amend entry 51 to Annex XVII of REACH, which now restricts the four phthalates listed in the table below.
|Item||Acronym||Name||Maximum Concentration (ppm)|
|3||DEHP||Bis(2-ethylhexyl) phthalate, (Di(2-ethylhexyl) phthalate)||0.1%|
Details of the amendments to REACH Annex XVII are as follows:
The proposed scope of restrictions now covers the following product types:
DIBP is a colorless, viscous liquid plasticizer commonly used in combination with other high molecular weight phthalates as a gelling aid in the manufacture of PVC, paints, printing inks and adhesives.
Previously, only manufacturers of childcare products containing plasticizers DEHP, DBP and BBP were affected by the restrictions outlined in Annex XVII. As of June 2019, manufacturers of products for children aged under 3 years old are also restricted from using DIBP.
The latest amendments now require all types of products containing the plasticizers BBP, DBP, DEHP, and DIBP to meet the requirements limiting the amount of restricted phthalates in any item to less than 0.1% of the entire article’s composition.
Most manufacturers must comply with the new directives by June 2019.
DIBP has been widely used as a substitute to DBP to negate the existing restrictions under Annex XVII for the manufacture of products such as PVC, rubber, fiberglass and plastic products, especially in Australia, where DIBP is imported predominantly for the production of PVC and rubber.
With DIBP now also restricted in childcare and other products, those manufacturers have to seek alternative plasticizers.
Electrical and electronic equipment (EEE) containing DEHP, DBP, BBP and DIBP are governed by RoHS 2 regulations, which also restrict the hazardous substances as homogeneous materials in articles to less than 0.1%.
Homogeneous materials are defined as substances that cannot be mechanically separated into different materials.
Other types of products included in the new amendments include but are not limited to the following:
For the purpose of this rule, ‘childcare article’ means any product intended to facilitate sleep, relaxation, hygiene, the feeding of children, or sucking on the part of children.
Under Annex XVII of the REACH regulation, the ECHA differentiates the restrictions on childcare products as those which can or can not be placed in the mouth of a child with the following definitions:
Articles or part of an article is less than 5 cm in one dimension and can be ‘placed in the mouth’, sucked and chewed. If the object can just be licked, it cannot be regarded as ‘placed in the mouth’. However, the shape of the article, e.g. the existence of detachable or protruding parts and its resistance to compression or deformation also needs to be given consideration.
Handheld toys are considered as ‘likely to be placed in the mouth’. However, toys which are not handheld are also included in the above guideline.
Here are some examples of childcare products with parts that can be placed in the mouth:
Articles Not Placed in the Mouth (Inaccessible Parts)
Parts or removable components that cannot be reached during proper use, or reasonably foreseeable improper use, by children. However, decision-making criteria are also based on “accessible” and “removable component” as defined in the European Standard on the safety of toys (EN 71).
Exceptions in Childcare Products
Cables made from plasticized material containing DINP, DIDP, DNOP or DIBP should be safely enclosed inside the toy.
With these new and frequently updated regulations, manufacturers of all types of products using plasticizers must ensure their suppliers are not using restricted substances.
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