Child resistant packaging has been developed in order to prevent that children get into contact with the contents of a bottle etc. that contains poisonous substances. There will never be 100 per cent safety, as adults should still be able to open the packages easily and quickly. However it should be noted that child resistance is not in existence to release a parent or care giver from their responsibility for small children, but as an aid or last defense!

Children are curious by nature and are unaware of the danger of these products and substances. They use their sense of touch and taste to discover the world around them and as such we have a duty to protect them, morally and legally. When a package is designed and then manufactured for these sorts of products it is typically tested in accordance with the child safety legislation in existence.

PTS Testing Service institute have been working towards better standards of child safety. as a testing laboratory for child resistant packaging. We are recognised for our high standards by both consumers and customers from within the industry.

Many years of success and our customers loyalty confirm that our professional work meets the expectations and requirements of our customers and society as a whole.

Testing and certification of packaging in accordance to the following standards: 

• ISO 28862 (2018)

• ISO 14375 (2018)

• ISO 8317 (2015)

• ISO 17480 (2015)

• EN 862 (2016)

• EN 14375 (2016)

• EN 13869 (2016)

• US 16 CFR § 1700.20 (PPPA)

• US 16 CFR § 1210

• AS 1928-2007

• AS 5014-2010

• AS 5808-2009

• CAN/CSA-Z76.1-16 (R2016)

• CAN/CSA-Z76.2-00 (R2010)

• AS/NZS 4867.2:2002

• DIN 15945 (2011-06)

Legal Requirements

Products such as house hold cleaning agents and medication through ingestion by small children can pose a serious threat to their health or even prove fatal. As such they are required to be packed in child resistant packaging. As a result of this national and international regulations and standards have been created and are enforceable. Manufacturers, suppliers and fillers use the certification to prove compliance of the packaging to the relevant authorities and among themselves.

Please see below a list of some of the most relevant laws in regards to child resistant packaging:

Products such as house hold cleaning agents and medication through ingestion by small children can pose a serious threat to their health or even prove fatal. As such they are required to be packed in child resistant packaging. As a result of this national and international regulations and standards have been created and are enforceable. Manufacturers, suppliers and fillers use the certification to prove compliance of the packaging to the relevant authorities and among themselves.

Please see below a list of some of the most relevant laws in regards to child resistant packaging:

• Directive 67/548/EEC on the approximation of laws, regulations and administrative

• Directive 1999/45/EC – classification, packaging and labelling of dangerous preparations

• Regulation 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures

• UK – SI 2003 No. 2317: The Medicines (Child Safety) Regulations 2003

• USA – Poison Prevention Packaging Act (PPPA) 15 U.S.C. § 1471- 76, (CPSC) US 16 CFR § 1700

• AUS – Therapeutic Goods Act (Order No.65)

• Drug Law (Arzneimittelgesetz (AMG)) requirements under paragraph 28

• Hazardous substance Regulation (Gefahrstoffverordnung (GefStoffV)) Germany only.

• Product Liability Act (Produkthaftungsgesetz (PHG))

CRP-Standards

Child resistant packaging began in America in 1970. The “Poisons Prevention Packaging Act” (PPPA) provides that products which can be harmful to children must be packaged in a child resistant way. Numerous accidents involving household, gardening and automotive chemicals as well as accidents involving drugs and other hazardous substances initiated the process of legislation. There has since been a marked decrease in the frequency and severity of incidents in the introduction of child resistant packaging. 

Under the PPPA standardised testing procedures for child safe packaging were fixed in order to guarantee their functional reliability. During these tests 200 children aged 42 to 51 months had to try and open a package. If 80% were not able to perform the task, the package could be considered child resistant. It was equally important, however, that adults, especially the elderly, were able to open and reseal the package as well. Many other countries followed the American example published under US 16 CFR § 1700.20 and established similar standards. 

Several legal requirements lay down the international use of child resistant packaging. The important standards for child safe packaging in brief in the text below.

ISO 8317 (2015)

ISO 8317 (2015) is the international standard for re-closable child resistant packaging. It applies to pharmaceutical as well as to chemical products. 

This standard has a two part testing procedure. The first test is with up to 200 infants aged 42 to 51 months, the children must not be able to open the packaging, while a group of people aged 50 to 70 must be able to open the packaging without difficulty. Only packaging that has been considered child resistant in tests with infants as well as convenient for elderly people according to the standards will meet ISO 8317 (2015).

Tests with infants aged 42 to 51 months

The children have five minutes to try and open the package in whichever way they can think of. After five minutes, they are given a demonstration of how to open the package and without any further explaination. Then the children have a further five minutes to open the package.

The packaging is to be regarded as child resistant if no more than 15 per cent of the children can open the package within the first five minutes. Over the whole testing period of ten minutes, no more than 20 per cent of the children should be able to open the packaging.

Tests with senior citizens aged 50 to 70

During the senior citizens test a group of 100 people aged 50 to 70 have to open a package within five minutes without any prior demonstration. In the second attempt they have to open it within one minute. The packaging is considered as suitable and convenient for senior citizens if at least 90 per cent of the group is able to open and reclose the packaging correctly.

The testing group of 100 people aged 50 to 70 is to be made up in the following way: 25 people aged 50 to 54, 25 people aged 55 to 59 and 50 participants aged 60 to 70. In every group, 70 per cent of the participants have to be women.

EN 862 (2016) / ISO 28862 (2018)

EN 862 (2016) – equivalent to ISO 28862 (2018) – is the international standard for non-re-closable child resistant packaging for non-pharmaceutical products.

There are different types of non-reclosable child resistant packages, such as packages where the content of which is used in one application (unit dose, one unit), refill packs, re-sealable bags, flow packs and packages that are made up of several joint single packages for single use (e.g. blister packs).

Non-reclosable means that the whole content is used all at once; the child safety mechanism cannot be reconstructed.

Similar to the testing procedures of ISO 8317, infants aged 42 to 51 months try to open the packaging within 5 (or 10) minutes. The evaluation is done as in ISO 8317 mainly.

Tests involving senior citizens between 50 and 70 are optional.

ISO 14375 (2018)

ISO 14375 (2018) – equivalent to EN 14375 (2016) – is the European standard for non-reclosable child resistant packages for pharmaceutical products.

This standard is especially relevant for blister packs, stick packs and granule bags.

As in ISO 8317, there is a two part test procedure in which it must be proven that infants aged 42 to 51 months cannot open the packaging while people between 50 and 70 years should be able to.

The testing procedures are predominantly the same as with ISO 8317, that is two tests of five minutes for infants and one test of five and one test of one minute for adults. There is, however, one important difference: During the infant tests, a packaging is to be considered as “opened” according to the standard only when the infant can remove more than eight units from the package (e.g. blister pack).

Please note that during these tests, the child must have access to at least ten units of dosage. The conclusion that a stick pack or a blister containing less than eight units does not need to be packaged in a child resistant way is wrong and might lead to serious accidents.

CEN/TS 15945:2011 / ISO 17480 (2015)

What can be done so that packaging can easily be opened by the majority of consumers? Well CEN/TS 15945:2011 / ISO 17480 (2015) provides a method by which both the packaging’s ease of opening and consumer satisfaction attributes can be assessed. It takes into account that with age, not only visual acuity and motor skills diminish, but also that the power of the hands starts to decrease. Easy opening is defined here as … “ease of handling during the opening process which is supported by the product packaging to give the consumer the chance to reach his or her key objective (s)”. The main objectives are effectiveness and efficiency while handling and the degree of consumer satisfaction with the handling process. Packaging is considered as easy to open if the majority of adult consumers describe it as effective, efficient and satisfactory according to the above criteria.

Target group test procedures according to CEN/TS 15945:2011 / ISO 17480 (2015)

There is a test procedure according to CEN/TS 15945:2011 / ISO 17480 (2015). It describes a test with a group of 100 randomly selected male and female participants aged 65 to 80, in accordance to the criteria table below. Participants are handed a sample pack that corresponds in its presentation to the package that will be commercially offered later on. The main objectives to be achieved by the consumers when opening the package are tested in three stages. They are as follows: “Testing effectiveness while opening” followed by “Checking efficiency while opening” and “Testing satisfaction with opening process”. A test is considered successful if in the first stage the opening procedure is evaluated by the participants as effective within five minutes. Then the opening procedure is repeated by the participants and is described to be efficient if they can open the package again in less than one minute. Satisfaction with the opening process can finally be expressed on a symbolic scale of “Smilies”, that each carries a numeric value.

Working together

For the market success of a product, the packaging plays an important role as it directly affects consumer satisfaction. But how is this to be achieved in individual cases? CEN/TS 15945:2011 is a suitable instrument. During packaging development it is possible to monitor consumer acceptance through targeted panel testing. In this way mistakes can be avoided and improvements discovered. In order to ensure that this process is successful and to fulfill the requirements of CEN/TS 15945:2011 a competent partner is needed. Accredited service providers provide qualified support, be it in the assistance of the choice of packaging or in providing the panel group testing according to CEN/TS 15945. Such collaboration ensures that the packaging meets the requirements of the producer, the product, consumers and society.