2019.1.12 update

 

2019.1.12 誤記訂正（フタルエステル類→フタル酸エステル類）

 

 

2018年12月18日　欧州委員会はREACH規則 制限対象物質であるフタル酸エステル類の制限条件の変更を発表しました。変更内容は以下のとおりです。

 

１）フタル酸エステル類を３種（DEHP、DBP、BBP)にDIBPを追加し、４種とした。
２）制限条件を以下のように変更した。

 

制限条件（新）

Entry 51

The following phthalates (or other CAS and EC numbers covering the  substance):

 

(a) Bis (2-ethylhexyl) phthalate (DEHP)
CAS No 117-81-7, EC No 204-211-0

 

(b) Dibutyl phthalate (DBP)
CAS No 84-74-2, EC No 201-557-4

 

(c) Benzyl butyl phthalate (BBP)
CAS No 85-68-7, EC No 201-622-7

 

(d) Diisobutyl phthalate (DIBP)
CAS No 84-69-5, EC No 201-553-2

 

Conditions of restriction

1. Shall not be used as substances or in mixtures, individually or in any  combination of the phthalates listed in column 1 of this entry, in a  concentration equal to or greater than 0,1 % by weight of the plasticised  material, in toys and childcare articles.

 

2. Shall not be placed on the market in toys or childcare articles,  individually or in any combination of the first three phthalates listed in  column 1 of this entry, in a concentration equal to or greater than 0,1 % by  weight of the plasticised material.
In addition, DIBP shall not be placed on the market after 7 July 2020 in toys or childcare articles, individually or in any combination with the first three phthalates listed in column 1 of this entry, in a concentration equal to or  greater than 0,1 % by weight of the plasticised material.

 

3. Shall not be placed on the market after 7 July 2020 in articles,  individually or in any combination of the phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material in the article.

 

4. Paragraph 3 shall not apply to:
(a) articles exclusively for industrial or agricultural use, or for use  exclusively in the open air, provided that no plasticised material comes into  contact with human mucous membranes or into prolonged contact with human  skin;
(b) aircraft, placed on the market before 7 January 2024, or articles,  whenever placed on the market, for use exclusively in the maintenance or repair of those aircraft, where those articles are essential for the safety and airworthiness of the aircraft;
(c) motor vehicles within the scope of Directive 2007/46/EC, placed on the  market before 7 January 2024, or articles, whenever placed on the market, for  use exclusively in the maintenance or repair of those vehicles, where the  vehicles cannot function as intended without those articles;
(d) articles placed on the market before 7 July 2020;
(e) measuring devices for laboratory use, or parts thereof;
(f) materials and articles intended to come into contact with food within the scope of Regulation (EC) No 1935/2004 or Commission Regulation (EU) No  10/20111;
(g) medical devices within the scope of Directives 90/385/EEC, 93/42/EEC or  98/79/EC, or parts thereof;
(h) electrical and electronic equipment within the scope of Directive  2011/65/EU;
(i) the immediate packaging of medicinal products within the scope of  Regulation (EC) No 726/2004, Directive 2001/82/EC or Directive 2001/83/EC;
(j) toys and childcare articles covered by paragraphs 1 or 2.

 

5. For the purposes of paragraphs 1, 2, 3 and 4(a),
(a) ‘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.
(b) ‘prolonged contact with human skin’ means continuous contact of more than 10 minutes duration or intermittent contact over a period of 30 minutes, per  day.
(c) ‘childcare article’ shall mean any product intended to facilitate sleep,  relaxation, hygiene, the feeding of children or sucking on the part of  children.

 

6. For the purposes of paragraph 4(b), ‘aircraft’ means one of the  following:
(a) a civil aircraft produced in accordance with a type certificate issued  under Regulation (EC) No 216/2008 or with a design approval issued under the  national regulations of a contracting State of the International Civil Aviation Organisation (ICAO), or for which a certificate of airworthiness has been  issued by an ICAO contracting State under Annex 8 to the Convention on  International Civil Aviation, signed on December 7, 1944 , in Chicago;
(b) a military aircraft.

 

制限条件（旧）

Entry 51

The following phthalates (or other CAS and EC numbers covering the substance):

 

(a) Bis (2-ethylhexyl) phthalate (DEHP)
CAS No 117-81-7, EC No 204-211-0

 

(b) Dibutyl phthalate (DBP)
CAS No 84-74-2, EC No 201-557-4

 

(c) Benzyl butyl phthalate (BBP)
CAS No 85-68-7,EC No 201-622-7

 

Conditions of restriction

1. Shall not be used as substances or in mixtures, in concentrations greater than 0,1 % by weight of the plasticised material, in toys and childcare articles.

 

2. Toys and childcare articles containing these phthalates in a concentration greater than 0,1 % by weight of the plasticised material shall not be placed on the market.

 

(3. Regulation (EU) No 326/2015: paragraph 3 is deleted.)

 

4. For the purpose of this entry ‘childcare article’ shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children.

 

参考

欧州委員会官報
https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1547003781168&uri=CELEX:32018R2005