ion

iss
o mm
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th
n of
o
siti
l po
ina
nyf
o fa
ta tive

15 th + 16th Amendment re pre

se n

ly
s ari
ces
ne
ot
d is n
, an
n
atio
s ult
n
co
f or
d
n an
o
FCM WG 24-25 February ussi
c
dis
tate
a cili
tof
d
u se
was
a tion
t
en
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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th
n of
o
siti
l po
ina
nyf
o fa
ta tive
e n
s
re pre
ly
s ari
ces
ne
ot
d is n
, an
n
a tio
s ult
n
Apologiesnd fofor
r the numbering confusion co

iona
s
s c us
di
tate
a cili
tof
d
u se
was
a tion
t
en
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
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15th and 16th Amendments on of
the

siti
l po
ina
n yf
o fa
15th voted positively on Friday it ve
16th for nexttatime (probably June SC)
s en
re pre
• A short discussion on some of its • Plan: r i l ydraft text next WG
sa
ces
elements ne
n ot
d i s • Focus on main policy elements
, an
• Focus on implementation n
atio
s ult
n
co
f or
d
n an
o
ussi
c
dis
tate
a cili
tof
d
u se
was
a tion
t
en
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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th
n of
o
siti
l po
ina
nyf
o fa
ta tive
e n
s
re pre
ly
s ari

15 th Amendment ot
ne
ces

d is n
, an
n
atio
s ult
n
co
f or
d
n an
o
ussi
c
dis
tate
a cili
tof
d
u se
was
a tion
t
en
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
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Updates to Annex I on of
the

siti
l po
ina
nyf
o fa
• nothing really remarkable ta tive
en
s
re pre
• detection limit for FCM 236 in note 28  0.002
sa
r i l y mg/kg
ces
ne
ot
• change to antimony trioxide; d is n
, an
• migration limit now clearly applies to n sources of antimony trioxide, not
ioall only its use as
a t
lt
additive n su
r co
o
n df
a
nregarding
• potential swelling issue io the treated TiO2
uss
c
e dis
i l i tat
ac
tof
d
u se
w as
a tion
t
s en
pre This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and
i s
th
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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Re-work of Annex II on of
the

siti
l po
ina
n yf
• Reasons fa o
ti v e
• lanthanides  Opinion has similar structure as basis for Article 6(3)(a)senta
p re
• a table is clearer as list is becoming longer re
r i ly
• LODs need to be addressed sa
c es
• to place restrictions on heavy metals that are likely impurities t ne + antimony
o
d is n
n
• Table 1 of Annex II should not be considered n , aa positive list (‘Union List’)
io
• Clarified in second paragraph of point 1 ofulAnnex tat II
n s
• However, Article 6(3)(a) is de-facto ar hidden co Union List
f o
d
n an
• Chromium: LOD applies unless
s sio hexavalent chromium in the material can be excluded
u
d isc
• PAAs: t a te
i l i
• new LOD of 2to ppb fac applies only to the REACH list
• Article 19 s+edSum<=10ppb to all others not in Annex I  primary basis for controls are documents
s u
• EURL w ahas method: contains 16 of the 22 PAA mentioned in REACH, 20 other PAAs
ti on
e nta
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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LOD concept on of
the

siti
l po
• Two reasons to assign a ‘ND’ limit with a defined LOD ina
nyf
1. on basis of Article 11(4)  no TDI/MoE established, high toxicity o
(origin: SCF list 4B) fa
ve ti
ta
sen
p re
re
list 4: rily
ssa
e ce
o tn
d is n
n
n,a
tio
2. lta
SML can be set, but is well belowsu(verified) analytical capability, typically heavy metals
con
for d
n an
s sio
u
• LOD traditionally fixed d iscat 10 ppb
t a te
i l i
• better methods f ac may be available, but not necessarily suitable for enforcement
o
e dt
s health protection needed  10 ppb needs to be lowered where possible
• still, improved
a su
w
• LOD ti on defined via PT organised by EURL  eventual accreditation needs to be possible
e nta
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and
i s
th
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
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Communication on LODs on of
the

siti
l po
f
• We will strengthen our communication to industry and stakeholders ina
ny a
f
iv eo
tat
• Over the next few years LODs will be lowered where possible
n
e s
p
• to come close to levels which would be required for adequatere health protection
re
ri ly
ssa
• Requirements in the DoC are being strengthened
e ce via 15th amendment
n
ot
d is n
, an
n
atio
s ult
Message: n
co
f or
d
• Testing is only a backstop;n anlow migration to be achieved via compliance work
sio
u s
• Explain Article 3 ofdRegulation isc 1935/2004 in this context
e
• 10 ppb (in Article i l i tat 11(4)) is not a migration limit!
o fac
• documentary d t controls based on composition and calculations to be used
u se
s
 lowering
• wa of LODs not considered as a burden
tion
nta
r ese
is p
This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

th
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
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Testing of appliances and equipment on of
the

siti
l po
ina
n yf
o fa
• Basis is simple, migration limit applies in the food prepared
i v e with appliance
tat
s en
• it should facilitate enforcement  not need to look at rparts r e
ep
a rily
• should also be easier for business operators cess
t ne
o
i sn
• Practice may not be so simple (as we d
, an noticed in drafting)
a t ion
• relatively easy to establish compliance, lt non-compliance more difficult
n su
c o
• please use the provision inndpractice for and provide your feedback
iona
s
c us
• Not applicable to eOML di s
t
• hard to tracefacback ilita to offending part
to
ed
• Coulds still us be used (perhaps) for screening in some cases
n wa
t a tio
s en
r e
is p
This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

th
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
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Repeated use on of
the

siti
l po
ina
nyf
o fa
• SML ta tive
n
r e se
• initially intended M3<M2<M1, so decreasing like in OML
y rep testing
ril
• provision was changed to ‘not exceed’  too complex s sa because of uncertainty and ND
e
n ec
• difficult to defend three times at same level,nobelow t SML would be non-compliant
s
ndi
• Migration not stable, i.e. goes up? Not a
, compliant even if below SML
t i on
a
• Should increase safety of materials s ult such as plastics containing Bamboo
n
r co
o
• However, testing burdennincreases df  three analysis needed
n a
s sio
u
• OML essentially unchanged d isc
t a te
i l i
• 1st paragraph f ac updated, 2nd paragraph clarified, 3rd paragraph strengthened
o
e dt
s
a su
w
ti on
e nta
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
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Transition on of
the

siti
l po
ina
nyf
o fa
• New Concept tive
n ta
• first 24 months: products placed legally on the market before r e se entry into force continue
ep market
rthe
• first 6 months: also new products still allowed to be on
ril y
essa
ec
• Time-line o tn
d is n
• June 2020: estimated entry into force; oldanrules (before amendment) can still be used
,
• December 2020: stop placing new products a t ion on the market developed under old rules
s ult
• June 2022: stop placing products on
r c on the market compliant with old rules
fo
d
n an
• Why? Reformulations may s sio be required  avoid enforcement issues
u
d isc
• Preference wascimore te staged approach applicable to different provisions
lita
a
• became overly to f complex
d
u se
th w as
• 16 amendmenttion
same approach, but also June 2022 end of transition
t a
s en
pre This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and
i s
th
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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e C
th
n of
o
siti
l po
ina
nyf
o fa
ta tive
e n
s
re pre
ly
s ari

16 th amendment ot
ne
ces

d is n
, an
n
atio
s ult
n
co
f or
d
n an
o
ussi
c
dis
tate
a cili
tof
d
u se
was
a tion
t
en
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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Discussion on of
the

siti
l po
ina
n yf
o fa
Discussion on i v e
No specific discussion on:
at nt
e
res
• phthalates + wood • Regulary repSubstances
il ar
• EFSA presentations ss
e c•e 2 so far identified, likely more
n
n ot • relevant for phthalates discussion
• biocides – possible approach d is
, an
n
atio • other suggestions received:
• DoC – change to template s ult
n
co • formatting of CAS Nos
f or
d
• reprocessing of plastic n an • FCM 3 and 13 inconsistent
o
ussi
is c
• cheese in table 3 to t e dAnnex III • However: please submit other
i l i t a
• suggestion from f ac industry observations quickly or remind us of you
to
d
u se earlier communications
• Wording/ wa
s DE translation FCM 151
n
t a tio
s en
r e
is p
This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

th
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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th
n of
o
siti
l po
ina
yf

Wood pre
se n ta tive
o fa
n

re
ly
s ari
ces
ne
ot
d is n
, an
n
atio
s ult
n
co
f or
d
an
EFSA Presentation
on
ussi
c
dis
Decision on Risk management policy
e
i l i tat
ac
of
Bamboo
d t
u se
w as
a tion
t
s en
pre This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and
i s
th
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
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Risk Management on of
the

siti
l po
ina
EFSA:
n yf
o fa
• Present authorisation based on “Wood cannot be considered
ti v e inert per se owing to the
ta
many low molecular
s en weight substances it contains, and
inertness cannot be maintained p reinto food, the safety of these constituents
when migrating re
rily
must besaassessed. Presently available information is
e s
• Future: species must be evaluated n ec
insufficient to support that the authorisation of
o t
i s n‘wood flour and fibres, untreated’ (FCM No 96) is in
on case-by-case basis , an
d accordance with Regulation (EC) No 1935/2004.
a t ion Given the chemical differences in composition of wood
ult
s
• Compatibility with the polymer c on shall species, the safety of migrants from these materials
for must be evaluated on a case‐by‐case basis,
be ensured n d
iona considering beyond species also origin, processing,
s
s c us treatment for compatibilisation with the host polymer and
d i
• This also applies a t eto other plant assessment of the low molecular weight constituents
i l i t
f ac migrating into food. This applies to other plant
materials ed to materials as well.”
s us
wa
ion
https://doi.org/10.2903/j.efsa.2019.5902
t a t
en
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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Transition on of
the

siti
l po
ina
nyf
o fa
• Entry into force of 16th amendment (t=0) tive
n ta
r e se
• t+6 months: business operators to register intention rto ep apply
il y
• not registered? No continued marketing of productessar
n ec
n ot
• t+9 months: deadline for application to EFSA i s
and
,
• registered, but not applied? No continued t i on marketing of product
a
s ult
n
• Applied? Can stay on market,foruntil: co
d
• Application not valid? 3 months n an for second attempt
s io
• EFSA states it is unsafe, s c us or submitted data does not support conclusion on safety
e di
t
• either fixed time
c ilitaexpired (3-4 years), or strict deadlines under stop-the-clock
a
• authorisation to f in Annex I (and may continue on the basis of that authorisation)
d
u se
w as
a tion
t
s en
pre This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and
i s
th
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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Options for bamboo (and corn) flour on of
the

siti
l po
fina
y
A. consider Bamboo flour is not legally B. acknowledge situation f an on left, but
o
on the market if used in plastic ta tive
continue allowing these products
n e
s
prere
• Why? r i l y
• Why? s sa
e
n ec
• EFSA opinion clarifies wood requires
n ot • ubiquitous marketing
narrower interpretation (by species) i s
d
, an
n
a tio • Bamboo remains under Transitional rules
• Bamboo is a grass, not a wood; wood
s ult
n
scope cannot be expanded, but should
r co be • wood, bamboo, corn, and similar plant based
f o
nd
narrowed on basis of EFSA aopinion flours remain under rules on previous slide
n
s sio
u
• Transition does not apply, d isc marketing of • Enforcement to take place on basis of:
a t e
ilit
plastics containing f ac Bamboo ends • SML/OML (Melamine + Formaldehyde)
to
d
• Condition:s uconsistent se enforcement
a • Transition approach (i.e. registration +
w
throughout
a tion Union is agreed dossier, on-going evaluation)
t
s en
pr e This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and
i s
th
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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th
n of
o
siti
l po
ina
yf

Phthalates pre
se n ta tive
o fa
n

re
ly
s ari
ces
ne
ot
d is n
, an
n
atio
s ult
n
co
f or
d
an
EFSA Presentation
o n
ssi
Discussion on Risk management iscu
a t ed
ilit
f ac
o
e dt
s
a su
w
ti on
e nta
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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Mandate to EFSA for re-evaluation on of
the

siti
l po
ina
nyf
o fa
• Currently under discussion
ta tive
e n
s
• Will include: re pre
ly
ss (in addition to those specifically ari
• Short exercise to establish which phthalates to include e ce
n
authorised, if any) and which materials to cover n ot
s
ndi
,a
• Protocols for inclusion of new scientific ncriteria for toxicological and exposure data to ensure
o
transparency and consistency ati
ult s
n
r co
• Establishment of a common submission/data format specifically for the reporting of the occurrence
f o
of phthalates from FCMsand
n
s
• Re-evaluation of the crisks sio to public health related to the presence of phthalates in foodstuffs
u
from FCMs d is
te
il ita
• All relevant f ac endpoints
o
e dt
s
• Co-exposure
a su
•n wContribution of FCM compared with other sources
t a tio
en
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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Risk management of phthalates in plastic FCM on of
the

siti o
a lp
in
Name TDI Allocation SML Group SML(T) (mg/kg)
n yf
(mg/kg bw) factor (mg/kg) o fa
ta tive
s en
r e
Dibutyl Phthalate 0,01 50% 0,3 ep
60 rmg/kg (sum of a number of substances)
i l y
(DBP) FCM 157 s ar
c es
ne
Butylbenzylphthalate 0,5 None 30not 60 mg/kg (sum of a number of substances)
s
(BBP) FCM 159 ndi
n,a
ti o
lta
Bis(2-ethylhexyl)phthalate 0,05 su
50%
n
1,5 60 mg/kg (sum of a number of substances)
co
(DEHP) FCM 283
f or
d
an
Di-isononylphthalate 0,15 sion None 9 (sum with DIDP)
usc
(DINP) FCM 728 is 60 mg/kg (sum of a number of substances)
ed
i l i tat
Di-isodecylphthalate fac 0,15 None 9 (sum with DINP)
to
(DIDP) FCM 729 sed 60 mg/kg (sum of a number of substances)
u
w as
a tion
t
s en
pre This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and
i s
th
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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Risk management of phthalates in plastic FCM on of
the

siti
l po
ina
yf
Name Authorised uses
n
o fa
Dibutyl Phthalate Only to be used as: ta tive
n
(DBP) FCM 157 (a) Plasticiser in repeated use FCM contacting non fatty-foods
r e se
repup to 0,05% in the final product
(b) Technical support agent in polyolefins in concentrations
rily
Butylbenzylphthalate Only to be used as: e ssa
n ec
ot
(BBP) FCM 159 (a) Plasticiser in repeated use FCM
s n
i non-fatty foods except for infant formulae and follow-on formulae
(b) Plasticiser in single-use FCM contacting
d
, an
Bis(2-ethylhexyl)phthalate Only to be used as: n
a tio
(DEHP) FCM 283 ult FCM contacting non fatty-foods
(a) Plasticiser in repeated use
s
n
co in concentrations up to 0,1% in the final product
(b) Technical support agent
f or
Di-isononylphthalate Only to be used a nd
as:
o n
(DINP) FCM 728 (a) Plasticiser
s si in repeated use materials and articles;
u in single-use FCM contacting non-fatty foods except for infant formulae and follow-on formulae
isc
(b) Plasticiser
d
te
(c)aTechnical
t
support agent in concentrations up to 0,1 % in the final product.
f a cili
Di-isodecylphthalate
d to Only to be used as:
(DIDP) FCM 729 se (a) plasticiser in repeated use FCM;
s u
n wa (b) plasticiser in single-use FCM contacting non-fatty foods except for infant formulae and follow-on formulae
t a tio (c) technical support agent in concentrations up to 0,1 % in the final product
s en
pr e This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and
i s
th
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
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Considerations siti
on of
th

l po
ina
nyf
o fa
1. Grouping of phthalates ta tive
e n
s
re pre
2. Allocation factors ly
s ari
ces
ne
ot
3. Risk management for other FCMs d is n
, an
n
atio
s ult
n
co
f or
d
n an
o
ussi
c
dis
tate
a cili
tof
d
u se
was
a tion
t
en
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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Grouping of phthalates on of
the

o siti
a lp
in
Name tTDI Allocation SML Group SML(T) (mg/kg)
n yf
(mg/kg bw) factor (mg/kg) o fa
ta tive
DBP 0,01 50% 0,3 60 mg/kg (sum s en of a number of substances)
r e
rep
a rily
s
es mg/kg (sum of a number of substances)
c60
BBP 0,5 None 30 n e
0,05 ot
i sn
mg/kg and
n,
DEHP 0,05 bw 50% tio 1,5 60 mg/kg (sum of a number of substances)
lta
su
c on
d for
DINP 0,15
n an None 9 (sum with DIDP)
s sio 60 mg/kg (sum of a number of substances)
cu
dis
DIDP 0,15 tate None 9 (sum with DINP)
a cili
tof 60 mg/kg (sum of a number of substances)
d
u se
• EFSA as
has set tTDI for 4 phthalates (individual tTDIs are the same)
w
on i
nta t
e
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
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Grouping of phthalates siti
on of
th

l po
ina
n yf
o fa
• DINP is currently grouped together with DIDP as current i v e analytical
n tat
r e se
methodology for the purposes of consistent enforcement rep means these two
a rily
substances are too difficult to distinguish without
ce
ss further validation
n e
n ot
• According to information collected as is
d part of SANTE’s survey, DINP is not
an
,
t ion
used together with low weight smolecular
a phthalates (DBP, BBP, DEHP)
ult
c on
d for
n an
• Endpoints related to reproductive and developmental toxicity, including for
o
ussi
DINP need to be revisited
dis
c in light of possible new data
tate
a cili
tof
d
u se
was
a tion
t
en
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
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Allocation factors on of
the

o siti
a lp
in
Name tTDI Allocation factor SML Group SML(T) (mg/kg)
n yf
(mg/kg bw) (mg/kg) o fa
ta tive
DBP 0,01 50% 0,3 60 mg/kg (sum s en of a number of substances)
r e
rep
a rily
s
es mg/kg (sum of a number of substances)
c60
BBP 0,5 None 30 n e
ot
i sn
and
n,
DEHP 0,05 50% tio 1,5 60 mg/kg (sum of a number of substances)
lta
su
c on
d for
DINP 0,15 None
n an 9 (sum with DIDP)
s sio 60 mg/kg (sum of a number of substances)
cu
dis
DIDP 0,15 tateNone 9 (sum with DINP)
a cili
tof 60 mg/kg (sum of a number of substances)
d
u se
was
a tion
t
en
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
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Allocation factors siti
on of
th

l po
ina
nyf
o fa
v e
• Not possible for EFSA to quantify contribution from [plastic]
i FCM
tat
sen
re pre
• However, evidence on use of phthalates in other r i l y FCMs, consumer products
s sa
e
and exposure via dust and air n ec
ot
d is n
, an
• Possible contribution of DIBP which on exerts comparable effects to DBP and to
l t ati
u
which consumers are also exposure ons (see Appendix C of EFSA opinion)
r c
o
n df
iona
• Current allocation factors c us
s are inconsistent and not in line with possible
dis
contributions from e
i l i ta other sources (see section 3.7 of EFSA opinion, ECHA 2017)
t
ac
tof
d
u se
w as
a tion
t
s en
pre This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and
i s
th
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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Risk management from other FCM on of
the

siti
l po
ina
n yf
o fa
• DBP, BBP, DEHP, DINP, DIDP used as plasticisers intarubber it ve although
e n
res
progressively phasing out those that are of a lowrepmolecular weight (DBP,
a rily
BBP, DEHP) ce
ss
n e
ot
d is n
• Also used as catalyst for polymerisation n
n,a
o
l t ati
u
ons
c
• May also constitute a significant f or contribution from FCM
d
n an
o
u ssi
c
• National rules or testandards dis already in place but only in some MSs (e.g. FR,
a
IT, NL, DE) to facilit
d
u se
w as
a tion
t
s en
pre This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and
i s
th
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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Possible outcome on of
the

o siti
a lp
in
yf
Name tTDI SML (mg/kg) Allocation SML (mg/kg) Group SML(T) (mg/kg)
n
(mg/kg no allocation factor with allocation o fa
bw) factor factor ta tive
s en
0,6 20% r e
DBP 0,01 0,12 (0,3)*
rep
rily
essa 0,6 mg/kg (sum of DEHP, DBP and BBP
30 n ec expressed as DEHP equivalents [DEHP*1 +
BBP 0,5 20% 6 (30)* t
i s no DBP*5 + BBP*0.1])
and
n,
3 20% a tio
ult 0,6 (1,5)*
DEHP 0,05 60 mg/kg (sum of a number of substances)
n s
co
f or
n d
DINP 0,15 n a20%
o
ussi
9 (sum ofdisDIDP c 1,8 (9)* (sum of with DIDP and DINP)
t a te
and i l iDINP) 20%
ac
DIDP 0,15
f 60 mg/kg (sum of a number of substances)
to
s ed
a su
w
on
* present SML; new SML subject to confirmation by EURL
ti
ta
en
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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e C
th
n of
o
siti
l po
ina
yf

Biocides pre
se n ta tive
o fa
n

re
ly
s ari
ces
ne
ot
d is n
, an
n
atio
s ult
n
co
f or
d
an
Risk management
on
ussi
c
dis
tate
a cili
tof
d
u se
was
a tion
t
en
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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C
Biocides (under Regulation 10/2011!)
ion
o f the
it
s
po
in al
yf
f an
• Present: iv
• Possible future approach: eo
tat
sen
• Not explicitly addressed (additive) re pre
a rily
• sDerogation under Article 6
• 1 or 2 listed in table 1 of Annex I e s
n ec “biocides may be used provided
• provisional list n ot
s appropriately authorised for FCM under
ndi
n,a the BPR”
ti o
a
s ult
n
co
f or • Commission will consult EFSA over
d
n an
o SML if SML would be needed
ussi
c
dis • SML for silver can be established
te
…

l i t a
a ci
tof
ed • suitability in polymer responsibility of
s
su
 ta ti on
wa business operator under Article 19
en
pres • Provisional list removed
This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

th is potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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Provisional list on of
the

siti
l po
ina
nyf
o fa
ta tive
e n
s
re pre
ly
s ari
ces
ne
ot
d is n
, an
n
atio
s ult
n
co
f or
d
n an
o
ussi
c
dis
tate
a cili
tof
d
u se
was
a tion
t
en
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
iss
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C
Discussion on of
the

siti
l po
fina
y
Advantages Disadvantages f an
o
ti ve
• simple • an SML still nta
r e se needs to be
y rep
established;
sa
ril likely via Commission
• resolves provisional list e s
ec
mandate
n
ot
d is n
• biocides are dealt with under BPR n
n,a • suitability in plastic not fully
t a tio
as originally intended u l
ons assessed by EFSA
r c
o
n df
• no double authorisation ion a approach
c uss • only use as additive in plastics
• when not on BPR e dis list: no awkward covered
remaining flisting i l i tat under R 10/2011
ac
to
d
u se
• Triclosan w as removed (no application
i o n
nta t
under BPR)
s e
s pre This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

thi
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
iss
o mm
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th
n of
o
siti
l po
ina
yf

Other matters pre

se n ta tive
o fa
n

re
ly
s ari
ces
ne
ot
d is n
, an
n
a tio
s ult
n
co
f or
d
an
Template based DoC - Towards the Digital economy
n
s sio
u
Reprocessing of plastics
d isc
t a te
i l i
Change to the listing of Cheese f ac in table 3 of Annex III
o
e dt
s
a su
w
ti on
e nta
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and
i s
th
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
iss
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C
Template based approach on of
the

siti
l po
ina
nyf
o fa
• First discussed for Glymo  ta tive
e n
s
re pre
• Also for plastics and recycled plastics ly
s ari
ces
ne
ot
• Annex IV describes what, not how d is n
, an
n
atio
• Template will s ult
n
r co
o
• precisely describe what isnrequired df
iona
• provide clear formatcufor ss Competent Authorities
dis
t e
• no more ‘disclaimers’
c ilita
fa
• to
allow forseddigital approach
s u
wa
tion
nta
r ese
is p
This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

th
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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Regulation (EC) No 282/2008: C
Reprocessing of plastics itio
n of
t h e

o s
• Idea originates from discussion under Recycling a lp
in
• This is an established practice, but trade is difficult, and is not recycling n yf
o fa
ta tive
• Drafting Example, e.g. include in Article 4 of Regulation 10/2011: en
r e s
“Plastic off-cuts and other scraps originating from moulding or y rep
ril
extrusion can be re-grinded and placed on the market as s sa
intermediate materials provided: ce
ne t
o
• The plastic has not been printed and has not come into contact i s nwith food
d
or other substances; , an
• no detectable degeneration of the plastic has occurred; a t ion
s ult
n
• and scientific evidence shows that the off-cut orcoscrapped plastic is still
compliant to the Regulation when mouldeddor forextruded for at least three
n an
consecutive extrusions under real and foreseeable manufacturing
io
conditions.” ss
is cu
t ed
ilita
• We may set out additionalcrules under GMP regulation (‘Annex C’)
f a
to manufacturing facilities
• appropriate collection in
s ed
a su
n w industry on precise rules/terminology
• Consultation with
t a tio
en
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
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Re-wording of line 07.04 in table 3 of Annex III on of
the

siti
l po
ina
yf
• Suggestion from Industry:
n
o fa
tive
• The term “processed cheese” in item C has a specific
meaning that does not match the examples given, but n ta
se
pre
instead processed cheese is identical to “melting cheese” in
item B. This is common knowledge and common usage, re
ly
see for example s ari
https://en.wikipedia.org/wiki/Types_of_cheese#Processed ces
ne
ot
• The term “soft cheese” in item C is being misinterpreted to is n
d
mean any cheese which is not hard – I have an example , anof
t
an enforcement authority classifying Brie as a soft cheese
a ion
even though logic would say it is close enough tosult
n
Camembert given as example in item B. I believer co the term
d
“soft cheese” as used next to cottage cheese fo is meant to
mean fromage frais, quark, cream cheesen an etc.
io
u ss
• The terms and examples in items d isc B and C need to be re-
distributed to cover three distinct t a te types of cheese: fresh
i l i
uncured cheese, ripened
o fac cheese and processed cheese.
The first two of those t
d are not currently identifiable in the
above table. s u s e
w a
• This suggestion n appears to make sense
t a tio
s en
pr e This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and
i s
th
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
iss
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Suggested approach on of
the

siti
l po
ina
nyf
A. Whole cheese with not edible rind – simulant E. o fa
ta tive
e n
s
pre
B. Fresh uncured cheese e.g. cottage cheese, quark,
ricotta, cream cheese, fromage frais etc. – simulants re
ly
B(*) and D1. s ari
ces
t ne
o
C. Ripened soft, firm or hard cheese without rind or with i sn
d
edible rind (natural rind, washed rind, bloomy or
, an
mould) e.g. gouda, camembert, stilton, gruyère, tion
lta
parmesan etc. – simulant D2/3. su
c on
D. Processed melting cheese e.g. wedges, dspreads and for
n an
sio
slices – simulant D2/3.
s c us
E. e
Brined or fresh cheese in aatliquid medium e.g. feta, di
i l i t
fac
mozzarella etc. :
d to
sesimulant D2.
• in an oily medium –
a su
• in an aqueous w medium – simulant B(*) and D1.
ti on
e nta
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and
i s
th
potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
iss
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Wording/ DE translation FCM 151 on of
the

siti
l po
ina
nyf
o fa
ta tive
e n
s
re pre
ly
s ari
ces
ne
ot
d is n
, an
n
atio
s ult
n
co
f or
d
n an
o
ussi
c
dis
tate
a cili
tof
d
u se
was
a tion
t
en
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.
 ion
iss
o mm
e C
th
n of
o
siti
l po
ina
yf

Many Thanks! pre

se n ta tive
o fa
n

re
ly
s ari
ces
ne
ot
d is n
, an
n
atio
s ult
n
co
f or
d
an
The SANTE.E.2 FCM team
on
ussi
c
dis
tate
a cili
tof
d
u se
was
a tion
t
en
pres This presentation does not reflect the official position of the Commission; it is meant to facilitate discussion and understanding of existing and

this potential new legislation, but should not in anyway be seen as giving a final interpretation of existing legislation or a proposal of new legislation.