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Our team of regulatory and compliance specialists are renowned within our industry as class leading. We aim to provide the right level of support and information, simply and accurately to give you complete peace of mind.

EN16615: 2015 A test for the efficacy of surface Disinfectant Wipes

EN16615:2015 is the new European Standard for Chemical disinfectant Wipes (also known as the 4-field test). It is a stringent quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical wiping action.

It is the first European standard (EN) developed to test the actual wipe efficacy rather than the extracted solution used in the wipe as per previous tests. The test is designed to better represent the effectiveness of wipes in use within a real world environment.

The following Technical Brief explains more about the benefits of EN16615 and demonstrates into how the test is performed:

How does Pal Comply?

We understand the importance of ensuring our wipes products perform effectively in the real world environments in which they are used. We see EN16615 as a critical measure of our wipes’ effectiveness and the Standard has become a key part of our product development and evaluation process. Pal wipes are tested in independent laboratories that have been certified to carry out the test method and we publish the results in the ‘efficacy summary’ available for each of our disinfectant wipe products.

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

REACH is an EU regulation that is intended to advance the safe use of chemicals and improve the protection of human health and the environment by ensuring companies understand, identify and manage the risks linked to the substances and products they manufacture or supply.

A critical element of the legislation requires manufacturers and importers to register chemical products they put on the market with the European Chemicals Agency (ECHA). Each product or substance requires a dossier of data to be submitted to enable users and suppliers up and down the supply chain to understand the relevant hazards and risks associated with it.

How does Pal comply?

Pal provides all customers with appropriate information on hazards and conditions of safe use for products. Pal also will ensure compliance under the CLP Regulation.

Biocidal Products Regulation (BPR)

The BPR governs the sale and use of biocidal products such as disinfectants used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria. The regulation is intended to better protect humans and the environment. The regulation came in to force September 2013. Product registration timings are dependent on the active substances contained in the product. Pal products containing Isopropanol are the first to be effected and will require dossier submission before June 2016. Other actives will follow.

How does Pal comply?

We have developed a comprehensive strategy for BPR that is being implementing  in stages over a period of 6 years. Product registration is complex and takes time. Each product family requires a large array of data to be generated to prove that it is not only safe for the user and environment but also that it has the right level of antimicrobial activity for the required application. We have a range of formulations under various Product Types that will be fully compliant with the BPR. As we are registering product families ourselves, we are able to work with other Companies to provide private label products under a ‘same product authorization’. Pal has invested considerable resource to ensure that our wipes  – and  yours, are safe and legal.

Classification, Labelling and Packaging (CLP)

A regulation aimed to protect workers, consumers and the environment by means of labelling which reflects possible hazardous effects of a particular chemical. It is also designed to bring labelling regulation in line with the Globally Harmonised System (GHS). All chemical products must be assessed for possible hazards and potential risks to human health and the environment and labelled according to the standardised system. The hazards are communicated through standard statements and pictograms on labels and safety data sheets.

How does Pal comply?

CLP regulations came into force in June 2015. All relevant Pal branded products comply with CLP regulation. Our regulatory team can also support private label clients with CLP compliant documentation.

Medical Devices Directive/Regulation (MDD)

The Medical Device Directives is a directive relating to the safety and performance of medical devices which were harmonized in the EU. For a manufacturer to legally place a medical device on the European market the requirements of the Directive have to be met and a CE mark applied.

How does Pal comply?

Pal manufacturers Class IIa non invasive medical devices. The medical devices and compliance to the Medical devices directive are routinely audited by BSI who are Pal’s notified body. Pal has registered medical devices in the EU, Africa, Middle East & Asia.

Cosmetic regulations

The EU Cosmetics Regulation protects consumers and makes sure that all cosmetic products on the European market are safe. Manufacturers, importers or the responsible person for placing the cosmetics products on the market must ensure that their products meet the required safety requirements. Compliance with the regulations is controlled by the national or regional competent authorities in the EU member states.

How does Pal comply?

Pal products classified as cosmetic products meet requirements of the cosmetic regulation. Product information files are available from our technical team and the products are registered on the CPNP portal.

Country specific regulations

Products that have ether cosmetic applications or disinfectant properties often fall under ‘country specific’ regulations that are enforced under the jurisdiction of the country in which the products are sold. These are often in addition to European or Regional legislation and may require specific registrations, compliance documentation or testing.

How does Pal comply?

Pal has experience of developing cosmetic and disinfectant products for use in over 40 countries and ensures that they are fully compliant with all required legislation in each. Our compliance team offers support to our partners in the form of knowledge, data, testing and documentation to make often complex regulatory challenges much easier to manage.