Play Safe: Certified Child Resistant Packaging
Child resistant packaging (CRP) is used to restrict access of small children to hazardous content such as drugs, cosmetics and household chemicals. The number of children who have suffered from ingesting toxic household substances is still startlingly high. Thus, child resistant packaging is a very important and complex issue for consumers, packaging manufacturers and bottlers when it comes to the safety of children, legal requirements and country specific regulations. Below are some of the most important questions and answers to give a short overview.
What products require CRP?
Numerous products present a risk of injury or illness when swallowed by children. On the one hand, these are household products such as cleansing agents, polishing fluid, chemicals used for gardening or cars, lighter fluid, lamp oil and even some cosmetic products containing high amounts of essential oil or alcohol. On the other hand, of course, pharmaceutical products.
Which laws apply?
In the European Union, there are mainly two legal sources (directive 1999/45/EC and 1967/548/ECC) in the field of chemical-technical products such as household cleansers. These directives say that products which can be dangerous to the health of children must have CRP that meets the standards of ISO 8317 or EN 862.There are no consistent rules for drugs and medical devices in the EU. That is why some member states have laid down their own country-specific laws. E.g. in Germany, the Federal Institute for Drugs and Medical Devices has compiled a list of several hundred active agents of drugs that have to have child resistant packaging. All packages for medical products falling under this category have to meet standard ISO 8317 or EN 14375. The legal requirements in the United States published under US 16 CFR § 1700 regard dangerous chemical-technical and for pharmaceutical products. US 16 CFR § 1700 lays down that dangerous household products, also most drugs available on prescription, require CRP.
What standards do child resistant packs have to meet?
In Europe, the most important ones are ISO 8317 for reclosable child resistant packaging, EN 862 for non-reclosable child resistant packaging for nonpharmaceutical products and EN 14375 for non-reclosable child resistant packaging for pharmaceutical products. In the United States, all kinds of CRP have to meet the requirements of US 16 CFR § 1700.20.
How to ensure that childresistant packaging meets the required standards?
Internationally operating companies are confronted with a multitude of countryspecific regulations, consequently, it is compulsory to play safe and use highquality certified packaging in order to be sure to fulfil the legal requirements of all countries. Child resistant packaging can only be so called in the legal sense if it is conform to the above-mentioned standards. It will only be internationally recognized, however, if it has been tested and certified by an institute that has been accredited according to EN 45011 as a certification body, for example IVM. (www.IVM-childsafe.de)
What are potential problems?
A specific closure alone is not child resistant and can not be certified. Only a complete package can be certified as child resistant. If a closure for reclosable CRP is used on different container sizes, ISO 8317 permits the certification of a package family. In this case, only the smallest and the largest container size have to be tested with the closure in question. Where can I find additional information about the design and the certification of CRP? IVM Institut VerpackungsMarktforschung in Brunswick, Germany (www.ivmchildsafe. de) has more than 30 years of experience in the field of CRP. Having a leadership role in designing, developing and certifying child resistant packaging, IVM has been accredited by the German Accreditation Council (Deutscher Akkreditierungsrat, DAR) as an official certification body; reference number: DAP-ZE 3156.00 according to EN 45011. This article is written by: Dr. Rolf Abelmann & Adriana Calabrese. www.childresistant.org