Commission Communication on the ways in which the Commission is to protect the intellectual property in connection with the development and manufacture of flavouring substances covered by Regulation (EC) No 2232/96 of the European Parliament and of the Council
Date: 1998-04-29
Institutions: European Commission
Subjects: confidentiality, flavouring, food additive, foodstuffs legislation, human nutrition, intellectual property

29.4.98

EN

Official  Journal  of  the  European  Communities

C  131/3

Commission  Communication  on  the  ways  in  which  the  Commission  is  to  protect  the  intellectual
property  in  connection  with  the  development  and  manufacture  of  flavouring  substances  covered
by  Regulation  (EC)  No  2232/96  of  the  European  Parliament  and  of  the  Council

(98/C  131/03)

(Text  with  EEA  relevance)

In  this  communication,  the  Commission  sets  out  the  ways  in  which  it  is  to  protect  the  intel(cid:220)
lectual  property  in  connection  with  the  development  and  manufacture  of  the  flavouring
substances  covered  by  Regulation  (EC)  No  2232/96  of  the  European  Parliament  and  the
Council  of  28  October  1996  laying  down  a  Community  procedure  for  flavouring  substances
used  or  intended  for  use  in  or  on  foodstuffs(cid:216)(˛).

The  ways  in  which  this  protection  should  be  conferred  by  the  Member  States(cid:216)(ˇ)  are  covered  in
the  recommendation  of  21  April  1998(cid:216)(—).

I.(cid:217)Need  to  protect  intellectual  property  concerning  certain  flavouring  substances

1.(cid:217)Under  Article  3(1)  of  Regulation  (EC)  No  2232/96,  the  Member  States  must  notify  the
Commission  of  the  list  of  flavouring  substances  which  may  be  used  in  or  on  foodstuffs
marketed  on  their  territory.  These  flavouring  substances  and  the  technical  data  relating  to
them  are  initially  communicated  to  the  competent  authorities  of  the  Member  States  by  their
manufacturers.  Under  Articles  3(2)  and  4(1)  of  Regulation  (EC)  No  2232/96,  this
in  a  register  and  evaluation  programme  made  public.
information  can  be  entered 
Throughout  the  Community  procedure  set  up  by  the  Regulation,  a  number  of  persons
should  have  access  to  this  information.

2.(cid:217)The  circulation  of  some  of  this  information  should  be  restricted.  The  development  of  certain
new  flavouring  substances  and  the  manufacture  of  certain  existing  flavouring  substances
calls  for  heavy  investment  by  the  manufacturers  in  research  and  production.  Flavouring
substances  which  are  not  inventions  cannot  be  patented.  The  development  and  manufacture
of  these  flavouring  substances  nonetheless  amount  to  trade  secrets  which  have  to  be
protected  against  acts  of  counterfeiting  and  unfair  competition.  The  authors  of  Community
legislation  took  account  of  this  situation  by  requiring  in  the  second  subparagraph  of  Article
3(2)  of  Regulation  (EC)  No  2232/96  that  these  flavouring  substances  be  "designated  in  such
a  way  as  to  protect  the  intellectual  property  rights  of  their  manufacturer’.  This  need  to
protect  intellectual  property  is  also  referred  to  in  recital  14  of  that  Regulation.  This
requirement  applies  not  only  to  flavouring  substances  notified  pursuant  to  Article  3(1)  of
Regulation  (EC)  No  2232/96  but  also  in  the  future  to  new  flavouring  substances  as  referred
to  in  Article  5(2)  of  the  Regulation.  This  requirement  applies  at  all  stages  of  the  Community
procedure  set  up  by  the  Regulation.

3.(cid:217)Intellectual  property  can  be  protected  through  the  confidentiality  of  the  technical  data
concerning  the  flavouring  substances  in  question.  It  is  necessary  to  define  the  ways  in  which
confidential  data  is  to  be  protected  by  the  Commission.

II.(cid:217)Ways  in  which  the  protection  of  this  confidential  data  is  guaranteed  by  the  Commission

1.(cid:217)At  all  stages  of  the  Community  procedure  set  up  by  Regulation  (EC)  No  2232/96,  the
the  necessary  steps

the  experts  which  assist 

Commission  and 

it  should 

take  all 

(˛)(cid:217)OJ  L  299,  23.11.1996,  p.  1.
(ˇ)(cid:217)Reference  in  this  communication  to  the  Member  States  also  covers  the  signatories  to  the  EEA

Agreement.

(—)(cid:217)OJ  L  127,  29.4.1998.

C  131/4

EN

Official  Journal  of  the  European  Communities

29.4.98

to  guarantee  protection  of  the  confidential  information  communicated  by  the  manufacturers
of  flavouring  substances  or  their  representatives.

2.(cid:217)Such  confidential  information  may  cover:

-(cid:217)the  nature  of  the  flavouring  substances,  their  origin  and  the  manufacturing  process,

-(cid:217)the  conditions  of  use  of  these  flavouring  substances, 

including  the  names  of  the

foodstuffs  in  or  on  which  they  may  be  used,

-(cid:217)all  the  information  which  is  not  generally  known  to  persons  belonging  to  the  circles
normally  dealing  with  the  type  of  information  in  question  or  which  is  not  easily
accessible  to  them  and  has  a  commercial  value.

3.(cid:217)Where  the  Member  State  notifies  to  the  Commission  a  list  of  the  flavouring  substances
which  may  be  used  on  its  territory,  it  should  clearly  indicate  which  substances  on  that  list
and/or  which  data  have  to  be  protected.  Having  received  the  notification,  the  Commission
then  assigns  a  code  number  to  the  flavouring  substances  in  question.  The  indication  in  a
document  of  such  code  numbers  in  place  of  confidential  information  is  sufficient  to
guarantee  the  confidentiality  of  such  information.  There  is  then  no  further  need  for  this
document  to  be  the  subject  of  protection  under  this  communication.  These  provisions
concern  in  particular  the  opinions  on  flavouring  substances  delivered  by  the  Scientific
Committee  for  Food.

4.(cid:217)The  need  to  protect  confidential  data  extends  to  all  stages  of  the  procedure  set  up  by  Regu(cid:220)
lation  (EC)  No  2232/96  in  the  following  three  areas:  the  possession  of  information,  its
dissemination  and  its  processing.  It  is  for  the  Commission  to  guarantee  such  protection  at  its
particular  level  in  each  of  these  areas  by  the  appropriate  means  (security  of  the  premises
where  such  data  is  stored,  security  of  data  transmission,  identification  of  copies  made  by
whatever  means  and  of  the  persons  for  whom  those  copies  are  intended,  confidentiality  of
the  translations,  etc).

5.(cid:217)At  all  stages  of  the  procedure,  the  confidential  data  is  accessible  only  to  those  persons  in
charge  or  directly  involved  in  the  administrative,  technical  or  scientific  processing  of  the
dossier,  namely:

-(cid:217)the  officials  and  other  employees  of  the  Commission  appointed  ex  officio  by  the
Secretary(cid:220)General  of  the  Commission  for  the  purposes  of  the  procedure  set  up  by  Regu(cid:220)
lation  (EC)  No  2232/96  as  well  as  the  officials  and  other  employees  who  may  be
involved  in  the  official  control  of  foodstuffs,  also  appointed  ex  officio  by  the  Secretary(cid:220)
General  of  the  Commission,  and  bound  by  the  obligation  of  professional  secrecy  under
Article  214  of  the  EC  Treaty,

-(cid:217)the  members  of  the  Scientific  Committee  for  Food  and  the  experts  chosen  by  that
Committee  to  assist  it,  bound  by  the  obligation  of  professional  secrecy  under  Article  214
of  the  EC  Treaty  and/or  Article  11  of  Commission  Decision  97/579/EC  of  23  July  1997
setting  up  scientific  committees  in  the  field  of  consumer  health  and  food  safety(cid:216)(˛),

-(cid:217)any  other  person  not  bound  by  the  obligation  of  professional  secrecy  under  national  or

Community  law,  but  required  to  sign  a  declaration  of  confidentiality.

6.(cid:217)The  bodies  representing  the  manufacturers  of  flavouring  substances  consider  it  sufficient  to
protect  confidential  data  on  a  flavouring  substance  for  a  period  of  five  years.  This  period
runs  from  the  date  on  which  the  Commission  receives  the  list  containing  the  flavouring
substance  in  question  or  any  dossier  concerning  any  new  flavouring  substance.  The  date  on
which  this  period  expires  should  be  entered  in  a  register  and  in  the  evaluation  programme.

(˛)(cid:217)OJ  L  237,  28.8.1997,  p.  18.