Furthermore the packaging material

must be suitable for routine process-

ing; the required output and a constant

quality level have to be ensured.

Legal requirements

for cosmetics packaging

It may be necessary to add some ef-

fective type of device to prevent fraud-

ulent or counterfeit copying, as well as

childproof packaging, especially where

it is required for medicinal products

and, in the case of natural cosmetics,

ecological credentials and sustain-

ability of the packaging can be highly

relevant. Further aspects to consider

are functionality, convenience and

other demands related to the specific

market.

The packaging requirements for

cosmetics and medicinal products for

26 COSSMA 5I2014

PRODUCTION PACKAGING

topical application* have some simi-

larity, but there are also important

differences.

Cosmetics packaging materials are,

according to §2 para. 6 No. 2 of the

German food law, regarded as items for

daily and common use11. Equally pack-

aging for foodstuffs are considered to

be items for daily and common use in

the sense of the above legislation, and

for which in Germany the so-called

Bedarfsgegenstände (daily needs) leg-

islation is valid. Within the EU, the two

EU regulations 10/20115 und 1935/

20043 are required to be used when

talking about food packaging. The

above-mentioned regulations however

do not refer to packaging for cosmet-

ics. In the absence of any other official

guidelines these regulations are how-

ever frequently used in practice to

check the conformity of the packaging,

i.e. cosmetics packaging materials are

compared with and judged against

foodstuffs packaging.

The EU regulation 1223/2009 on

cosmetic products demands the fol-

lowing in Annex I (cosmetic product

safety report): “Information about the

packaging material: The relevant char-

acteristics of packaging material, in

particular purity and stability“12. There

are no further concrete demands in the

regulation on cosmetic products. This

safety evaluation is a basic part of the

product information file. Therefore it

can be checked by the food control

agency. The supplier company also will

often confirm, in the shipping docu-

mentation, that the packaging material

conforms to Article 17 of the regulation

on cosmetic products.

Article 17 states that „the non-in-

tended presence of a small quantity

(traces) of a prohibited substance (pro-

hibited in cosmetic products according

to Annex II of the regulation on cosmet-

ic products), stemming from (...) migra-

tion from packaging, which is technical-

ly unavoidable in good manufacturing

practice, shall be permitted provided

that such presence is in conformity with

Article 3“. Article 3 of the regulation on

cosmetic products states that “a cos-

metic product made available on the

market shall be safe for human health

when used under normal or reasonably

foreseeable conditions of use”.

Examples of substances that are

listed in Annex II of the European reg-

ulation on cosmetic products, and

Packaging materials for cosmetics

Does cosmetics packaging also come under the draft printing ink decree,

which forbids the use of mineral oil inks?

Primary packaging materials for

cosmetics have to be carefully

developed or must be selected

from amongst materials already on the

market. A basic requirement of packag-

ing is the protection of the contents of

the pack. In particular there must be an

adequate barrier against water vapour,

UV light, oxygen and CO2. Furthermore

it must be assured that no components

or ingredients of the packaging can mi-

grate into the product, and there must

be no adsorption or absorption of

components from the product into the

packaging.

In addition the packaging must be

non-hazardous, i.e. it must not contain

any toxic substances, as well as not be-

ing capable of transmitting any sub-

stance into the product which may be

in a potentially toxic concentration.

ph

oto

: K

ub

ais

, S

hu

tte

rsto

ck

.co

m

www.cossma.com

which could be found in packaging ma-

terials, include bisphenol A, plasticis-

ers such as dibutyl phthalate, certain

mineral oil fractions, e.g. coming from

printing inks, such as MOAHs (Mineral

Oil Aromatic Hydrocarbons) etc.

For pharmaceutical packaging

made from plastic, extractables/leach-

ables studies are carried out in certain

cases.

By leachables one refers to ingredi-

ents of the packaging materials that,

during the lifetime of the product, may

migrate into the contents of the pack.

By extractables one refers to ingre-

dients of the packaging that can be ex-

tracted under high-stress laboratory

conditions (e.g. high temperatures,

use of organic solvents as the extrac-

tion medium).

When packaging for cosmetics is

concerned the extractables/leachables

data tests are usually only carried out

where the absence of certain undesir-

able substances (e.g. phthalates) is not

specifically mentioned in the suppliers

data sheets, or substances with a

specified migration limit are present

(see below).

How does one define

“traces”?

The term traces can be specified fol-

lowing to the regulation on plastic ma-

terials 10/2011. The categories here

are the overall migration limit (OML),

specific migration limit (SML) and total

specific migration limit ((SML(T)).

According to regulation 10/2011,

SML means the maximum permitted

amount in mg/kg of a given substance

released from a material or article into

food or food simulants.

Using this test medium (food simu-

lant) it is possible to measure the mi-

gration level of substances from food

contact materials. Specific features of

the medium such as lipohilic and hy-

drophilic properties, acidity or alkalin-

ity are taken into account.

For substances for which no specif-

ic migration limit or other restrictions

are provided in Annex I of regulation

10/2011 a generic specific migration

limit of 60 mg/kg shall apply.

SML(T) is the maximum permitted

sum of particular substances, e.g. a spe-

cific substance group such as plasticis-

ers, released in food or food simulants

expressed as total of moiety (in mg/kg)

of the substances indicated. According

to regulation 10/2011 the OML means

the maximum permitted amount of

non-volatile substances that may be re-

leased from a material or article into

food simulants. It is set to 10 mg per

dm2 of food contact surface area.

For plastic materials and articles in-

tended to be brought into contact with

food for infants and young children the

OML is set to 60 mg/kg. It is not tied to

the surface area of the packaging. The

reason for this is that, in the case of

small packages, where the surface to

volume ratio is higher, the resulting

migration into food is also increased.

Examples of restricted

substances

The use of bisphenol A (BPA) is for-

bidden within the EU, in line with reg-

ulation 10/2011, in the production of

feeding bottles for babies. Other than

this, for use in foodstuffs, a total migra-

tion value of 0.6 mg/kg13 is specified in

regulation 10/2011.

With reference to mineral oils,

which may arise, for example, from

sources such as printing inks and pack-

aging made from recycled materials,

there are plans by the German food,

agriculture and consumer protection

ministry (BMELV) for a mineral-oil and

a printing ink regulation14,15 to be ap-

plied in the area of foodstuffs. The draft

of this printing ink regulation foresees

a ban on the future use of mineral-oil

based inks on foodstuffs packaging.

According to the second draft of the

mineral-oil regulation14 aromatic min-

eral oil hydrocarbons (MOAHs) with

a number of carbon atoms between

10 and 25 must not migrate into food-

stuffs. No concrete limit of detection

has been specified so that the result of

the analysis is, amongst other things,

dependent on the analytical procedure

being used and its particular limit of

detection.

Supplier qualifications and

approvals

The relevant GMP guideline for cos-

metics manufacturing is DIN EN ISO

22716. When purchasing packaging A

PACKAGING PRODUCTION

w w w . l u t z - p a c k a g i n g . d e

Lutz GmbH & Co. KG

Am Stammholz 11 · 97877 Wertheim / Germany

Phone (+49 93 42) 96 07-0 · Fax (+49 93 42) 96 07-20

e-mail: info@lutz-packaging.de

Please visit us:

5-6 June 2014, Munich

Hall 2, Booth D10

Luxurious ampoules packaging for the cosmetics industry

If the substances are of highest quality, the

packaging should be ambitious as well. An extra-

ordinary customized printing of our ampoules,

made of clear and amber glass, again improves

visually the contents of your ampoules. The use of

special designed trays for e.g. the bathroom

guarantees an optimum storage and protection of

your luxurious ampoules.

We are at your service for any assistance you

may need for your individual packing solutions.

Additional information can be found

at www.health-and-beauty.com/

qr00244

or you can just scan the QR code!

Your access codes for May:

User name: cossma5

Password: active

DownloadsDown loads

www.cossma.com

PACKAGING PRODUCTION

For the touch of luxury in glass

packaging

materials one has to decide for specific suppliers. These suppliers

can be suitably qualified using, amongst other things, question-

naires, Certificates of Quality (COQs) and, where necessary, audits.

Cosmetics packaging suppliers are often just dealers and detailed

information can sometimes be difficult to obtain, especially if the

packaging comes from the Far East.

In accordance with the above-mentioned DIN standard the pack-

aging material should be checked and approved by the appropriate-

ly trained personnel. This approval must be performed at the time of

goods inwards on the basis of supplier certificates and, if necessary,

by carrying out tests on samples from the shipment.

The batch-documentation covering each delivery must, in accor-

dance with the EU directive on product liability 85/374/EG, be re-

tained for 10 years after the product is put onto the market.

The Acceptable Quality Levels (AQLs) and the extent of sampling

should be bilaterally agreed. This usually happens according to

defect evaluation lists from the Editio Cantor Verlag (ECV)17 and can

be displayed in the form of limit boards where the type of failure,

sample quantity and AQLs are clearly shown.

Certain parameters, such as text, colour etc. are often 100%

checked by the supplier with an in-line camera system. Expensive de-

structive testing, such as the measurement of the hydrolytic resist-

ance or the breaking force of glass ampoules, is normally carried out

on a sample basis.

The supplier confirms, on the delivery certificate, that the agreed

quality has been checked and that the shipment is in line with that

quality.

At the client’s goods inwards facility, or that of his sub-contractor,

the packaging material is mostly checked based on the suppliers

sample testing with regard to appearance (text, colour), product

integrity, and, where necessary, level of microbiological quality. To

check on the analytical quality it is possible, for instance, to identify

the plastic using infra-red or, in the case of glass, to confirm the

hydrolytic class.

With a good working knowledge of the supplier and extensive

experience (10 out of 10 problem-free deliveries) a less intense level

of testing or a skip-lot procedure can be adopted18.

It is also important that reports on the routine manufacturing

processes coming from the production department are taken into ac-

count. In certain unusual circumstances it may well become neces-

sary to increase the sampling frequency or to carry out more detailed

quality sampling. If an unacceptable quality situation cannot be cor-

rected then the supplier of the packaging material is obliged to stop

delivery until an acceptable solution is identified and applied.

Faced with a background of growing demands being placed on

cosmetics packaging it is certainly a necessary step to look closely at

one’s own products. The first steps here are, among other things, the

acquisition of the appropriate documents described above, as well

as the recently released IKW (The German Cosmetic, Toiletry, Per-

fumery and Detergent Association) documents concerning the safe-

ty evaluation of cosmetics packaging.

Source: a presentation by the author as part of the APV seminar: ”What is the real difference be-tween topically applied pharmaceuticals and cosmetic products, and what do they have in com-mon?” given on 7.11.2013

*Further information on the legal requirements for pharmaceutical packaging and a literature list can be found on the Internet (see Internet panel)

www.cossma.com

Just how innovative

are newly

launched ingredients?

Sustainable actives are

shown to produce

an even complexion

The new role of

ingredients distributors

Suppliers of processing,

packaging + laboratory

services at a glance

E 512 8 0

C O S M E T I C S

S P R AY T E C H N O L O GY

M A R K E T I N G

Focus: Actives5 / 2 014

w w w . c o s s m a . c o m

Dr. Andrea Kühn of

Wala looks at the cur-

rent legal position and

regulations covering

cosmetics packaging

VIP of the Month

www.cossma.com