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69

frequent with these products: the comparatively highly

concentrated washing agent is released from the capsule

as a jet, often causing severe irritation in the mouth or

eyes. The percentage of accidents that require hospital

treatment is far higher with liquid cap products than with

traditional laundry detergents. After oral contact with the

liquid caps content children often vomit multiple times.

When the first scientific studies and media reports had

described the increased risk of poisoning, laundry deter-

gent manufacturers launched measures to improve prod-

uct safety (A.I.S.E. Product Stewardship Programme):

these measures included the use of opaque outer pack-

aging, better seals and additional warning information.

However, implementation of these measures did not

achieve the desired effects. For this reason, the Europe-

an Commission introduced far stricter legal requirements

for laundry detergent capsules: since mid-2015 the cap-

sule film must contain a bittering agent that is designed

to dissuade children from licking them. In addition, the

pods must withstand higher pressures and the outer

packaging has to be equipped with a safer seal and has

to be opaque in order to make the coloured caps invis-

ible when the seal is closed.

Together with Public Health England, the National Health

Institute in Italy and eight European poisons centres, the

BfR is investigating whether these new measures actually

do reduce the risks: in a study on behalf of the European

Commission, all calls to the participating poisons centres

related to exposures to liquid cap products are being

registered and the callers provided medical advice. The

next day, a poisons centre staff member calls back and

enquires about the circumstances of the accident in de-

tail. It is particularly important to determine what makes a

product attractive to children: According to Article 35 of

the European CLP Regulation (EC No 1272/2008), con-

sumer products that are classified as hazardous should

not be designed in such a way that they can attract the

active curiosity of children or mislead consumers – due

to the fact that the packaging makes them think of food

or drinks, for example.

The collection of case data began in August 2015 and

will continue until the spring of 2016. Up to the end of

the year, there was no discernible trend in poisoning fre-

quency in Europe. Preliminary analysis indicates that the

number of reported accidents in Germany is at least not

showing further increase. The final report to the Europe-

an Commission in summer 2016 will outline the findings

of the study and assess all current and potential future

safety measures for liquid cap products geared towards

reducing the risk of poisoning.

Risk assessment of tobacco additives

The new European tobacco directive came into force in

2014 and had to be transferred into national law by the

member states by 20 May 2016. In Germany, a new To-

bacco Products Act and a tobacco directive have been

introduced. Among other things, the European directive

introduces combined text-image warnings, the percent-

age of space on the packaging for warnings is higher

than before, and – for the first time – regulations have

been agreed upon at European level regarding electron-

ic cigarettes and novel tobacco products.

One of the tasks of the BfR is to assess tobacco ad-

ditives, which should not further increase the already

considerable health risks associated with tobacco. This

relates not only toxicity but also product properties and

compounds that might increase addiction potential or

make it easier to inhale tobacco smoke, such as for ex-

ample menthol. The new regulations are also designed

to restrict the options for the development and market

launch of more attractive products for smokers. It is for

this reason that aroma capsules and characteristic fla-

vours are to be banned for cigarettes and other tobacco

products. Also prohibited for tobacco products in future

is the suggestion of supposed health benefits, vitality or

an active “lifestyle”.

In terms of consumer protection, the new European stip-

ulations improve the way in which tobacco is regulated

in a number of important ways. At the same time, the

enactment of the new Tobacco Products Act means that

the previous approval obligation for tobacco additives in

Germany no longer applies – with the result that addi-

tives that used to be inadmissible during the production

process may now be used unless they are explicitly pro-

hibited. It is therefore to be expected that the range of

additives and the range of products will increase mark-

edly in the coming years. This will also create new tasks

and new challenges for risk assessment activities.

i

The BfR Opinion no. 045/2015 (in German) contains

detailed information on the health assessment of additives

for tobacco products and electronic cigarettes and can

be found at:

www.bfr.bund.de > Publikationen > BfR-Stellungnahmen > 2015

Tobacco additives may not further increase the already

considerable health risks associated with tobacco.

Product Safety