On December 18, 2018, the European Union published (EU) 2018/2005 in its official gazette, amending Article 51 of the REACH Regulation Restrictions (Appendix XVII) regarding the control requirements for phthalates, and adding new requirements for DIBP Control, expand the scope of control of four o-benzene substances, and include non-toys and child care products under control.
The regulations will come into force on the 20th day after the official gazette is published and apply to all member states.
Substance
Bis(2-ethylhexyl) phthalate (DEHP) (CAS Number: 117-81-7)
Dibutyl phthalate (DBP) (CAS number: 84-74-2)
Butyl benzyl phthalate (BBP) (CAS number: 85-68-7)
Diisobutyl phthalate (DIBP) (CAS number: 84-69-5)
Control requirements
1. It is forbidden to contain one or four of the four phthalates (DEHP, DBP, BBP, DIBP) with a combined concentration equal to or greater than 0.1% of plasticized materials used in toys and child care products.
2. It is forbidden to use plasticized materials containing one or three of the three phthalates (DEHP, DBP, BBP) with a concentration equal to or greater than 0.1% for toys and child care products on the market.
In addition, from July 7, 2020, it is prohibited to use diisobutyl phthalate (DIBP) alone or with three other kinds of plasticized materials with a concentration equal to or greater than 0.1% in toys and child care products. Target market.
3. From July 7, 2020, articles containing one or four of the four phthalates (DEHP, DBP, BBP, DIBP) with a combined concentration equal to or greater than 0.1% of plasticized materials are prohibited Listed.
4. Paragraph 3 does not apply to:
a. Articles specifically for industrial or agricultural use, or only used outdoors, provided that there is no plasticized material in contact with human mucosa or in contact with the skin for a long time;
b. Aircraft put on the market before January 7, 2024, or items that are specifically used for maintenance or repair of these aircraft and are essential to the safety and airworthiness of the aircraft at any time;
c. Motor vehicles that are put on the market before January 7, 2024 and fall within the scope of Directive 2007/46/EC, or items that are specifically used to repair or repair these vehicles whenever they are placed on the market, and vehicles that do not have these items Cannot be used normally;
d. Items placed on the market before July 7, 2020.
e. Measuring device and its components for laboratory use
f. Materials or articles that come into contact with food within the scope of (EC) No 1935/2004 or (EC) No 10/2011(*);
g. Medical equipment and its parts within the scope of 90/385/EEC, 93/42/EEC or 98/79/EC;
h. Electrical and electronic products within the scope of 2011/65/EU;
i. Direct packaging of drugs within the scope of (EC) No 726/2004, 2001/82/EC or 2001/83/EC;
j. Children's toys and child care products within the scope of paragraphs 1 and 2.
5. With regard to paragraphs 1, 2, 3 and 4(a):
a. "Plasticized material" refers to any of the following homogeneous materials:
─Polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyvinyl acetate (PVA), polyurethane,
─Any other polymers (including polymer foams and rubber materials) except for silicone rubber and natural latex coatings,
─Surface coating, anti-skid coating finishing, decals, printing design coating,
─Adhesives, sealants, paints and inks.
b. "Prolonged skin contact" refers to continuous contact time of more than 10 minutes per day or intermittent contact time of more than 30 minutes per day.
c. "Child care products" refer to any products designed to promote children's sleep, relaxation, hygiene, and children's feeding or sucking.
6. For the purposes of paragraph 4(b): "Aircraft" means one of the following:
a. Civil aircraft produced in accordance with the type certificate issued by (EC) 216/2008 or the design approval issued by the national regulations of the International Civil Aviation Organization (ICAO) Contracting States, or the ICAO Contracting States in Chicago on December 7, 1944 Civil aircraft that have signed an airworthiness certificate in Annex 8 of the Convention on International Civil Aviation;
b. Military aircraft.
As a widely used plasticizer, in addition to the REACH regulation restriction list for the EU's control of these four o-benzenes, the RoHS directive and the REACH regulation SVHC candidate list all have control requirements for them. CTI reminds relevant companies to timely understand and master the use of this substance, carry out supply chain investigations, and strengthen the control of this hazardous substance.
The regulations will come into force on the 20th day after the official gazette is published and apply to all member states.
Substance
Bis(2-ethylhexyl) phthalate (DEHP) (CAS Number: 117-81-7)
Dibutyl phthalate (DBP) (CAS number: 84-74-2)
Butyl benzyl phthalate (BBP) (CAS number: 85-68-7)
Diisobutyl phthalate (DIBP) (CAS number: 84-69-5)
Control requirements
1. It is forbidden to contain one or four of the four phthalates (DEHP, DBP, BBP, DIBP) with a combined concentration equal to or greater than 0.1% of plasticized materials used in toys and child care products.
2. It is forbidden to use plasticized materials containing one or three of the three phthalates (DEHP, DBP, BBP) with a concentration equal to or greater than 0.1% for toys and child care products on the market.
In addition, from July 7, 2020, it is prohibited to use diisobutyl phthalate (DIBP) alone or with three other kinds of plasticized materials with a concentration equal to or greater than 0.1% in toys and child care products. Target market.
3. From July 7, 2020, articles containing one or four of the four phthalates (DEHP, DBP, BBP, DIBP) with a combined concentration equal to or greater than 0.1% of plasticized materials are prohibited Listed.
4. Paragraph 3 does not apply to:
a. Articles specifically for industrial or agricultural use, or only used outdoors, provided that there is no plasticized material in contact with human mucosa or in contact with the skin for a long time;
b. Aircraft put on the market before January 7, 2024, or items that are specifically used for maintenance or repair of these aircraft and are essential to the safety and airworthiness of the aircraft at any time;
c. Motor vehicles that are put on the market before January 7, 2024 and fall within the scope of Directive 2007/46/EC, or items that are specifically used to repair or repair these vehicles whenever they are placed on the market, and vehicles that do not have these items Cannot be used normally;
d. Items placed on the market before July 7, 2020.
e. Measuring device and its components for laboratory use
f. Materials or articles that come into contact with food within the scope of (EC) No 1935/2004 or (EC) No 10/2011(*);
g. Medical equipment and its parts within the scope of 90/385/EEC, 93/42/EEC or 98/79/EC;
h. Electrical and electronic products within the scope of 2011/65/EU;
i. Direct packaging of drugs within the scope of (EC) No 726/2004, 2001/82/EC or 2001/83/EC;
j. Children's toys and child care products within the scope of paragraphs 1 and 2.
5. With regard to paragraphs 1, 2, 3 and 4(a):
a. "Plasticized material" refers to any of the following homogeneous materials:
─Polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyvinyl acetate (PVA), polyurethane,
─Any other polymers (including polymer foams and rubber materials) except for silicone rubber and natural latex coatings,
─Surface coating, anti-skid coating finishing, decals, printing design coating,
─Adhesives, sealants, paints and inks.
b. "Prolonged skin contact" refers to continuous contact time of more than 10 minutes per day or intermittent contact time of more than 30 minutes per day.
c. "Child care products" refer to any products designed to promote children's sleep, relaxation, hygiene, and children's feeding or sucking.
6. For the purposes of paragraph 4(b): "Aircraft" means one of the following:
a. Civil aircraft produced in accordance with the type certificate issued by (EC) 216/2008 or the design approval issued by the national regulations of the International Civil Aviation Organization (ICAO) Contracting States, or the ICAO Contracting States in Chicago on December 7, 1944 Civil aircraft that have signed an airworthiness certificate in Annex 8 of the Convention on International Civil Aviation;
b. Military aircraft.
As a widely used plasticizer, in addition to the REACH regulation restriction list for the EU's control of these four o-benzenes, the RoHS directive and the REACH regulation SVHC candidate list all have control requirements for them. CTI reminds relevant companies to timely understand and master the use of this substance, carry out supply chain investigations, and strengthen the control of this hazardous substance.