EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11248/2016 
(POOL/E3/2016/11248/11248 -EN.doc)  
[…](2016) XXX  draft 
  
COMMISSION DIRECTIVE (EU) .../…  
of XXX  
amending Directive 2001/18/EC of the European Parliament and of the Council as 
regards the environmental risk assessment of genetically modified organisms    
EN 2   EN COMMISSION DIRECTIVE (EU) .../…  
of XXX  
amending  Directive 2001/18/EC of the European Parliament and of the Council as 
regards the environmental risk assessment of genetically modified organisms  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Directive 2001/18/EC of the European Parliament and of the Council  of 
12 March 2001 on the deliberate release into the environment of genetically modified 
organisms and repealing Council Directive 90/220/EEC1, and in particular Article 27  thereof,  
Where as: 
(1) Directive 2001/18/EC of the European Parliament and of the Council  sets out 
requirements for the environmental risk assessment genetically modified organisms 
('GMOs') . 
(2) On 4 December 2008, the Council adopted Conclusions on GMOs stressing the need 
to update and strengthen the environmental risk assessment of GMOs, in particular 
concerning the assessment of long -term environmental effects  
(3) Following a request  from the Commission , the European Food Safety Authority 
(EFSA ) adopted in October 2010 a Scienti fic opinion establishing guidance on the 
environmental risk assessment of genetically modified  plants2 ('the Guidance') , which 
is a revis ion of  the previous guid ance. 
(4) Article 3 of Directive (EU) 2015/412 of the European Parliament and of the Council3 
provi des that  by 3 April 2017  the Commission has to  update the Annexes to Directive 
2001/18/EC  as regards the environmental risk assessment  with a view to incorporating 
and building upon the Guidance .  
(5) In order to adapt to technical progress and taking into account the experience gained in 
the environmental risk assessment of genetically modified plants, t he essential 
elements of the G uidance should b e incorporated in Directive 2001/18/EC.  In doing 
so, the principle that the environmental risk assessment  shou ld be carried out on a 
case-by-case basis  should be respected.  
(6) Part C of Annex II  to Directive 2001/18/EC  concern s the methodology of the 
environmental risk assessment. It  should be updated in order to incorporate , in 
particular, t he comprehensive step -by-step assessment approach consisting of six steps  
described in the Guidance and the terminology used.  
(7) Part D  of Annex II  to Directive 2001/18/EC applies to the conclusions of the 
environmental risk assessment  and contains two distinct sections , concerning GMOs  
                                                 
1 (OJ L 106, 17.4.2001, p. 1.  
2 EFSA Journal 2010;8(11):1879 . 
3 Directive (EU) 2015/412 of the European Parliament and of the Council  of 11 March 2015 amending 
Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the 
cultivation of genetically modified organisms (GMOs) in their territory  (OJ L 68, 13.3.2015, p. 1).   
EN 3   EN other than higher plants (section D.1) and genetically modified higher plants (section 
D.2) respectively.  The G uidance considers seven specific areas of risk to be addressed 
in the environmental risk assessment  of genetically modified  plants in order to draw 
conclusions. The structure and content of section D.2 of Annex II should therefore be 
updat ed to reflect those areas of risk . 
(8) Where the environmental risk assessment concerns a genetically modified plant made 
tolerant to a herbicide, its scope shou ld be consistent  with Directive 2001/18/EC. The 
environmental risk assessment of the use of a plant protection product to be authorised 
under Regulation (EC) No 1107/2009 of the European Parliament and of the Council4, 
including its use on a genetically mo dified plant, falls under the scope of that 
Regulation and will be carried out at Member State level to take into account the 
specific agricultural conditions .  
(9) Annex III B  to Directive 2001/18/EC  lists the information required in notifications 
concerning releases of genetically modified higher plants  and applies to both  
notifications for the purpose of placing on the market ( "Part C notifications ") and 
notifications for other purposes than placing on the market ( "Part B notifications "). Its 
structure, content and level of detail should be amended to ensure consistency with  the 
Guidance. As most of the changes induced by the Guidance concern the environmental 
risk assessment of Part C notifications , and  in the interest of clarity and simpl ification 
for the notifiers and the competent authorities, it is appropriate to modify  the structure 
of Annex III  B by separat ing the requirements concerning Part C notifications from 
the requirements concerning Part B notifications.  
(10) The m ajority of the re quests for authorisation of the placing on the market of 
genetically modified plants are submitted in acc ordance with Regulation (EC) 
No 1829/2003 of the European Parliament and of the Council5. In the interest of 
simplification , it is therefore appropriat e to align , to the extent possible,  the order of 
the pieces of information  required for Part C notifications  in Annex III B to Directive 
2001/18/EC with the order followed in  Commission Implementing Regulation (EU) 
No 503/20136. 
(11) Annex IV to Directive 2001/18/EC sets out additional information requirements  only 
for Part C notifications. The requirements set out in th at Annex concerning detection 
methods should be updated in the light of technical progress, in particular as regards 
the submi ssion by notifiers of  the reference material.  
(12) The measures provided for in this Directive are in acc ordance with the opinion of the  
Committee  set up under Article 30 of Directive 2001/18/EC , 
                                                 
4 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on the market and repealing Council Directives 
79/117/EEC and 91/414/EEC (OJ L309, 24.11.2009, p. 1).  
5 Regulation (EC) No 1829/2003 of the  European Parliament and of the Council of 22 September 2003 
on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1).  
6 Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for 
authorisation of genetically modified  food and feed in accordance with Regulation (EC) No 1829/2003 
of the European Parliament and of the Council and amending  Commission Regulations (EC) 
No 641/2004 and (EC) No 1981/2006  (OJ L157, 8. 6.2013, p.  1).  
EN 4   EN HAS ADOPTED THIS DIRECTIVE:  
Article 1  
Annexes II, III , III B  and IV to Directive 2001/18/EC are ame nded in accordance with the 
Annex to this Directive.  
Article 2 
1. Member States shall bring into force the laws, regulations and administrative 
provisions necessary to comply with this Directive by [18 months from the date  of 
entry into force ] at the latest. They shall forthwith communicate to the Commission 
the text of those provisions.  
When Member States adopt those provisions, they shall contain a reference to this 
Directive or be accompanied by such a reference on the o ccasion of their official 
publication. Member States shall determine how such reference is to be made.  
2. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Direct ive. 
Article 3 
This Directive shall enter into force on the twentieth day following that  of its publication  in 
the Official Journal of the European Union .  
Article 4 
This Directive is addressed to the Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER