Resolution MS No 583/2008  
Having reg ard to item no 2002 -2041/08 -3 on the records of the Ministry of Health , and 
whereas:  
Children , as developing organisms, are particularly  vulnerable  to chemicals  with the 
specific properties  in questi on (toxic to reproduc tion and /or endocrin e disrupting ). The 
exposure  of children  to any sources of emission of these substance s which can be 
avoided in practice , and especially  articles which children  may put in their mouths , 
should be reduc ed as much as possible , guarant eeing  the maximum level  of protection  
regardless of the age of the children concerned . 
Within this conceptual framework by means of Resolution No 978 of 9 December 1999 
the former Ministry of Health and Social Action restri cted the possibility of children  
interacting with elements cont aining various compound s in the phthalate  family 
constituting a potential or proven risk to their health . 
That decision  has subsequently been  ratifi ed and developed in  Ministerial Resolutions  
No 438 of 30 April 200 1, No 324 of 31 May 200 2, No 180 of 24 February 2004 and 
No 243 of 10 March 2006 because there are still reasons for banning the manufacture , 
import , export , marketing  or free distribution  of certain c hildcare articles  and toys for 
children  under the age of THREE (3) to pu t in their mouths  which are manufactured 
with: Di-(2-ethyl hexyl) phthalate  (DEHP) CAS No 117 -81-7, Di-iso-nonyl phthalate 
(DINP), CAS No 28553 -12-0, din -octyl phthalate  (DNOP o r DOP), CAS No 117-84-0, 
diisodecyl phthalate  (DIDP), CAS No 26761 -40-0, but ylbenzyl phthalate  (BBP), CAS 
No 85-68-7 and dibut ylphthalate  (DBP), CAS No 84-74-2. 
The conditions which underlay the abovementioned Resolutions still obtain , and were 
ratified by Directive 2005/84/EC of the European Parliament and of the Council of 14 
Decem ber 2005 , which restricts the marketing and use of certain dangerous substances 
and preparations  (phthalates in toys and childcare articles) and was published in Official 
Journal No L 344 of 27 December 2005 pp. 0040 -0043.  
The available scientific informa tion and the evalua tions of the toxicological hazard 
carried out in the European Union  permit  DEHP, DBP and BBP to be defined as 
reprotoxic  substances (clas sified within the CMR --carcinogenic, mutagenic and toxic to 
reproduction -- category of substances ). 
Scientific information  relati ng to DINP, DIDP and DNCP is inexistent  or debated , but 
given children's unforeseeable behaviour  and the problem  of precisely determin ing the 
daily intake  of a specific substance , their representing a potential hazard cannot be ruled 
out if they are used in toys and c hildcare articles  which , by defini tion, are manufactured 
for children  and which these may put in their mouths . 
Exposure to DEHP, DBP and BBP from toys can be avoided ; it is not clear that their use 
in toys is nece ssary or beneficial to children and it may possibly represent the greatest 
proportion of children's total exposure to these chemicals from all known sources (the 
environment, air in closed spaces, food, etc.) that can be controlled by specific measures.  
Depending on the protocol of the observation study  of children putting toys in their 
mouths, children have been shown to put objects in their mouths for times ranging 
between a few minutes (United States Consumer Product Safety Commission ) and more 
than six hours (United Kingdom DTI study and Japanese reports), which reinforces the doubts as to what is the worst case in terms of the time taken before children put a toy in 
their mouth and the need for an appropriate level of caution in the conclusions regardin g 
exposure to phthalates from toys.  
Uncert ainties  in the evalua tion of exposure  to these phthalate s, such as how often 
children will put them in their mouths , the probable presence of more than one phthalate  
in toys, additional exposures  via foods  and air and skin contact  with these , demand that 
precautionary considera tions be taken into account and restrictions therefore be set for 
the use of these phthalate s in toys and c hildcare articles  and on the marketing  of these 
articles . 
Given the different  levels of scientific evidence  and for reasons of propor tionali ty the 
restrictions  for DINP, DIDP and DNOP should be less sever e than those proposed for 
DEPH, DBP and BBP.  
There are alternative substances (such as citrates and adipates) which can be used as 
plasti cisers in toys and childcare articles . The European Union Scientific Committee on 
Toxicity, Ecotoxicity and the Environment has evaluated the safety studies of these and 
concluded, in an opinion of 8 June 2004, that there was no reason for concern regardin g 
the use of acetyl  tri-Butyl Citrate (ATBC) as a plasticiser in toys and childcare articles 
which small children may put in their mouths.  
It falls to the State to determin e the essential safety requirement s to be met by product s 
that are freely sold and/o r widely used and to guarant ee the population that the 
substance s used in manufacturing toys do not comprom ise their safety  in foreseeable 
conditions of use . 
This body of the State is responsible for adopt ing appropriate measure s to prote ct the 
population' s health  in respect of any factor which is a health hazard . 
Given that there are no restriction s on such product s in the countries in the region and 
that trade between some of them directly  crosses the territory of the Republic of 
Argentina , it is necessar y to specify that the measure s provided for herein shall not apply 
to goods  arriving on the customs territor y in direct  transit to a foreign destin ation so as 
not to create obstac les to commercial relations between our neighbours . 
The Directorate -General o f Legal Affairs has taken the steps for which it is responsible . 
Accordingly , 
THE MINIST ER OF HEALTH  
HEREBY RESOLVES:  
Article I – The manufacture , import , export , marketing  or free distribution of c hildcare 
articles  and toys manufactured with plasticised material cont aining concentrations  in 
excess of 0.1% by mass of the following phthalate s (or other CAS numbers containing 
the substance ) shall be banned : 
di(2-etilhexil) phthalate  (DEHP) CAS No 117 -81-7; 
dibut ylphthalate  (DBP) CAS No 84 -74-2; 
butylbenzylphth alate  (BBP) CAS No 85 -68-7. Article 2  – The manufacture , import , export , marketing  or free distribution  of c hildcare 
articles  and toys which children may put in their mouths  manufactured using plasticised 
material cont aining concentrations  in excess of Z ERO POINT ONE PER CENT (0 .1%) 
by mass of the following  phthalate s (or other CAS numbers containing the substance )  
shall be banned : 
Di-iso-nonyl phthalate  (DINP) CAS No 28553 -12-0 and 68515 -48-0; 
Diisodecyl phthalate (DIDP) CAS No 26761 -40-0 and 68515 -49-1; 
di-n-octyl phthalate (DNOP) CAS No 117 -84-0. 
Article 3  – Whenever c hildcare articles  and toys of flexible material clear ly are not 
manufactured using the esthers of phthalic acid named in the preceding articles enter the 
country  a technical report prepar ed by the Plastics Industry Research and Technological 
Development Centre  (CITIP - INTI)  attesting to this fact must be submitted to the 
Directorate -General for Customs . 
Article 4  -- This Resolution  shall come into force on the date of its publication in t he 
Boletín Oficial  for those  childcare articles  and toys hitherto not covered by the equivalent 
provisions . 
Article 5  – Goods arriving on the customs territory in direct transit to a foreign 
destination shall be excluded from the provisions of Articles 1, 2 and 3. 
Article 6  – For the purposes of t his Resolution a "childcare a rticle"  is defined as  any 
product  intended to facilitate  children's sleep , rela xation , hygiene  and feeding or nursing . 
Article 7 – The National Programme for the Prevention and Control of Intoxications  
shall be responsible  for requesting and evalua ting any new information  permit ting the 
rules in force to be updated . 
Article 8  – The measure s laid down in Articles 1  and 2 shall not apply to goods  arriving 
on the customs territory in direct  transit to a foreign destination  so as to avoid hampering 
commercial relations between the neighbouring countries . 
Article 9  -- Resolutions  No 978 of 9 December  1999, No 438 of 30 April 200 1, No 324 
of 31 May 200 2, No 180 of 24 February 2004 and No 243 of 10 March 2006 of this 
Ministry are hereby repealed.  
Article 10  -- To be communicated by authenticated copy of this Resolution to the F air 
Trade Directorate of the Subsecretariat for Competition and Consumer Protection of the 
Ministry of Economic Affairs a nd Production and to the Directorate -General  for Customs  
of the Federal Revenue Administration of the Ministry of Economic Affairs and 
Production for their information and adop tion of the corresponding measure s within the 
areas of their responsibilities . 
Article 11  -- To be communicated, published and given to the National Directorate for 
the Official Register. Copy for archives . -- María G. Ocaña.