EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2018) XXX  draft  
ANNEX 1  
 
ANNEX  
to the  
COMMISSION REGULATION (EU) .../...  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH) as regards bis(2 -ethylhexyl) phthalate (DEHP), 
dibutyl phthalate ( DBP), benzyl butyl phthalate (BBP) and diisobutyl phthalate (DIBP)    
EN 1  EN ANNEX  
Entry 51 of Annex XVII to Regulation (EC) No 1907/2006 is replaced by the following:  
 
“51.  
Bis(2 -ethylhexyl) phthalate 
(DEHP)  
CAS No.: 117-81-7 
EC No.: 204 -211-0 
 
Dibutyl phthalate (DBP)  
CAS No.: 84 -74-2 
EC No.: 201 -557-4 
 
Benzyl butyl phthalate (BBP)  
CAS No.: 85 -68-7 
EC No.: 201 -622-7 
 
 
Diisobutyl phthalate (DIBP)  
CAS No.: 84 -69-5 
EC No.: 201 -553-2 
  
1. Shall not be used as substances or in  
mixtures, 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 after [OJ 
please insert date: 18 months after the date 
of entry into force] in articles in a 
concentration, of one or more of the 
phthalates  listed in column 1 of this entry , 
that is equal to or greater than 0,1% by 
weight of any plasticised material in the 
article.  
3. Paragraph 2 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 prolonged contact 
with human skin;  
(b) aircraft, or motor vehicles within the scope 
of Directive 2007/46/EEC, plac ed on the 
market before [OJ please insert date – 60 
months after the date of entry into force] , or 
to articles, whenever placed on the market, 
for use exclusively in the maintenance or 
repair of those vehicles or aircraft;  
(c) articles placed on the market bef ore [OJ 
please insert date: 18 months after the date 
of entry into force] ; 
(d) measuring devices for laboratory use, or 
parts thereof;  
(e) materials and articles intended to come into 
contact with food within the scope of 
Regulation (EC) No 1935/2004 or 
Commission  Regulation (EC) No 
10/2011(*);  
(f) medical devices within the scope of 
Directive s 90/385/EEC, 93/42/EEC or  
EN 2  EN 98/79/EC, or parts thereof;  
(g) electrical and electronic equipment within 
the scope of Directive 2011/65/EU;  
(h) the immediate packaging of medicinal 
products within the scope of Regulation 
(EC) No 726/2004, Directive 2001/82/EC or 
Directive 2001/83/EC.  
4. For the purposes of paragraphs 1, 2 and 3(a), 
(a) "plasticised material" means the 
following homogeneous  materials:  
- polyvinyl chloride (PVC), other polymers 
such as polyvinylidene chloride (PVDC) and 
polyvinyl acetate (PVA), as well as any 
other plastics, except polyolefins,  
- rubber, except silicone rubber and natural 
latex coatings,  
- polyurethanes and any other foam rubber 
or foam plastic,  
- 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 m inutes, 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.”  
 
5. For the purposes of paragraph 3(b), 
“aircraft” means one of the following:  
(a) a civil aircraft produced in accordance 
with a type certificate issued under 
Regulation (EU) 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.  
 
  
  
EN 3  EN (*) Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food 
(OJ L 12, 15.1.2011, p. 1) ”.