REACH Appendix XVII Restrictions on the Use of Four Phthalates for Plasticizing Materials in All Articles
On December 18, 2018, the Official Journal of the European Union issued Directive (EU) 2018/2005, which stipulates that all plasticizers in articles must comply with the requirements of Annex XVII, Item 51 of REACH for the four phthalates (DIBP, DEHP, DBP, and BBP). This directive came into effect on January 7, 2019.
This directive adds a DIBP restriction regulation to the restricted substances in Appendix 17 of the REACH regulation, and the restricted phthalates in Item 51 of Appendix XVII have been changed to the following four types:
Dibutyl phthalate (DBP)
Butyl benzyl phthalate (BBP)
Di (2-ethylhexyl) phthalate (DEHP)
Diisobutyl phthalate (DIBP)
The restriction requirements for phthalates in Annex XVII, Item 51 of REACH are as follows:
| Restriction requirements for phthalates | Phthalate ester limit | effective date |
| Toys and child care products containing three types of phthalates (DEHP, DBP, BBP) are not allowed to be placed on the market | DEHP, DBP, BBP (single or total concentration) of plasticizing materials<0.1% |
Effective |
| Four types of phthalates (DEHP, DBP, BBP, DIBP) are not allowed to be used in toys and children's products | DEHP, DBP, BBP, DIBP (single or total concentration) of plasticizing materials<0.1% |
2019.1.7 |
| Toys and child care products containing four types of phthalates (DEHP, DBP, BBP, DIBP) are not allowed to be placed on the market | DEHP, DBP, BBP, DIBP (single or total concentration) of plasticizing materials<0.1% |
2020.7.7 |
| Items containing four types of phthalates (DEHP, DBP, BBP, DIBP) are not allowed to be placed on the market (excluding items listed in point 3) | DEHP, DBP, BBP, DIBP (single or total concentration) of plasticizing materials<0.1% |
2020.7.7 |
The restriction requirements for phthalates in items (excluding toys and child care products) do not apply to:
1. Plasticized materials that are not in contact with human mucous membranes or have prolonged contact with human skin, but are specifically used for industrial or agricultural purposes, or for outdoor use;
2. Aircraft placed on the market before January 7, 2024, or any items placed on the market at any time, which are specifically designed for maintenance or repair of these aircraft and play a critical role in their safety and performance;
3. Motor vehicles placed on the market before January 7, 2024, or any items placed on the market at any time, which are specifically designed for maintenance or repair of these vehicles and without which the vehicles cannot function as expected;
4. Items placed on the market before July 7, 2020;
5. Measurement devices and their components used in the laboratory;
6. Products and materials that come into contact with food within the scope of Regulation (EC) No 1935/2004 or (EC) No 10/2011;
7. Medical devices and their components within the scope of Directive 90/385/EEC, 93/42/EEC or 98/79/EC;
8. Electronic and electrical products within the scope of Directive 2011/65/EU;
9. Direct packaging of drugs within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC or Directive 2001/83/EC.
remarks:
1. Plasticized material "refers to the following homogeneous materials:
Polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyvinyl acetate (PVA), polyurethane;
Any other polymer except silicone rubber and natural latex coating (including high-risk materials such as foam polymer and rubber materials);
Surface coating, anti slip coating, finishing, decal, printing design coating;
Adhesives, sealants, paints, and inks.
2. Long term skin contact "refers to continuous contact for more than 10 minutes per day or intermittent contact for more than 30 minutes per day.
3. Child care products "refer to any products designed to promote sleep, comfort, hygiene, feeding, or sucking in children.
