Managing product safety together.

; Established in 1987

; IPO 1997

; 20,000 Employees

; 200 Laboratories

; Present in 39 Countries

; > 130,000 Methods

; Revenue 2014: 1.41 bn €

The Eurofins Group

Who we are

Consumer Product Testing (CPT)

Eurofins ScientificWith over 20,000 staff in around 200 laboratories across 39 countries, Eurofins Scientific is the world leader in food, environment and pharmaceutical products testing. It is also one of the global market leaders in agroscience, genomics, discovery pharmacology, and central laboratory services.

The Hamburg unit Eurofins Consumer Product Testing GmbH is specialised in testing articles with direct consumer contact. This especially includes consumer products, such as articles belonging to household, decoration, toys, food con-tact materials (FCM), as well as cosmetics, hygiene products, detergents, and biocidal products.

With our services, we cover the testing from raw materi-als to finished products; furthermore, we offer inspection and certification services, trainings, as well as consultancy according to our clients’ individual wishes. Providing a comprehensive testing portfolio we serve the complete international supply chain. Suppliers of raw materials, manufacturers, importers, national and international retail-ers are among our customers. Our team of experts provides comprehensive, cost effective, and practical test plans and offers. In addition, upon request, we gladly consider in-dividual specifications and requirements. Afterwards, the analytical results are judged according to their compliance with the relevant legal requirements (national, European, and international), as well as recommendations from the authorities, such as the BfR (German Federal Institute for Risk Assessment). For the analysis of the many parameters, we can rely on the broad analytical portfolio of the Eurofins group worldwide and, therefore, offer various analyses, such as laboratory analyses, microbiology, usability tests, consumer studies, etc.

Our ISO 17025 accreditation ensures precise and reliable test results. This is confirmed by our constant, successful participation in round robin tests. In addition, the consequent implementation of lean-management enables us to provide short turnaround times.

; High expertise

; Short turnaround times

; Personal consultancy

CPT stands for:

Legend laboratories:

Food and Feed

Pharma

Agroscience

Genomics / Forensic

Consumer Product Testing

Environment

Corporate Offices

Eurofins Locations

Cosmetics

Your Challenge:

Within the European Community, Regulation (EC) No 1223/2009 harmonises legislation referring to cosmetics products. Thereby, it generates a high standard with respect to the safety for human health by stipulating that cosmetic products must not harm human health when applied under normal or reasonably foreseeable conditions of use. In particular, a risk benefit assessment should not justify a risk to human health.

The use of cosmetic products is defined as place-ment in contact with the external parts of the human body or with the teeth and the mucous membranes of the oral cavity. The purpose of cosmetics is described as exclusively or mainly cleaning, perfuming, and protecting the human body, but also changing its appearance, as well as keeping it in a good condition, or correcting its odours.

Our services for the following fields skin – hair – decorative cosmetics:

; Chemical & physical analyses

; Microbiological tests

; Tolerance and sensitisation tests

; Efficacy tests

; Sensory tests

; Regulatory affairs

Your Challenge:

Both hygiene papers as well as feminine hygiene products are inherent parts of daily used consumer products. Actually, consumers deal with them generally several times a day. Therefore, the producers attach specific value on the reliability as well on quality of their products. Hygiene papers are, amongst others, tissues and kitchen paper towels, which come directly into contact with the human body. In contrast, articles, such as pads, panty liners, napkins, and tampons, function as absorbers for the body’s excretions. The Federal Institute for Risk Assessment (BfR) has stipulated recommendations concerning both products to serve as a means for evaluating them.

Moistened hygiene products, e.g. toilet paper, refreshing wipes, or cleaning tissues, are used in order to maintain babies’ and women’s hygiene, facial care, as well as cleaning cloth with regard to housekeeping and healthcare.

The use of a specific fluid determines a particular corresponding application, thereby bringing further regulations, such as the European Cosmetics Code or the Detergents Regulation, into play.

Hygiene

Our Services:

; Chemical & physical analyses

; User and efficacy tests

; Sensorial tests

; Tolerance and sensitisation tests

; Regulatory affairs

Our Services:

; Chemical & physical analyses

; User and efficacy tests

; In-Vitro Tests

; Tolerance and sensitisation tests

; Regulatory affairs

Your Challenge:

In any household detergents belong to the pro-ducts of daily use. Dishwashers as well as washing machines are permanently running in order to facilitate our daily routine. Thereby, the consumer constantly increases their expectations regarding the performance, efficiency, and surplus of such products.

The German Association of Cosmetics, Perfume, Toiletries and Detergents (IKW) is committed to the particularly demanding standards of product quality and safety giving recommendations on various issues of mutual concern. In contrast, legal regula-tion (EC) No 648/2004 is important with regard to detergents. Producers are obliged to give detailed information about ingredients. Furthermore, in Germany, the Federal Institute on Risk Assessment (BfR) requests notifications relating to detergents.

Regulation (EC) No 1272/2008 (CLP regulation: Classification, Labelling and Packaging) entered into force on 01 June 2015. It is the only existing law that directs the method of classifying and labelling chemicals, based on the United Nations’ Globally Harmonised System (GHS). Thus, the classi- fication of a substance is harmonised and made obligatory at the Community level to ensure an adequate worldwide risk management with the aim to reduce harm due to circulating chemicals. Besides the chemicals that are affected by REACH, this new regulation also comprises, amongst others, biocidal products, pesticides, and consumer goods, such as dyes and detergents.

Detergents

Your Challenge:

Any substances or mixtures, which are used for purposes other than agricultural purposes are defined as biocides, if they are for preventing the action of, or otherwise exert a controlling effect on, any harmful organism by any means other than mere physical or mechanical action. Biocides are needed in many private as well as professional ar-eas, and due to their objectives they are potentially harmful to the environment and to the health of human as well as animals.

Therefore, only those products are allowed to be placed on the market, wherein their biocidal active components are filed in the Union-List, that, in turn, shows the approved active substances. Furthermore, these products should have passed the approval procedure in compliance with the legal regulations.

Legislation (EU) No 528/2012 is fundamental by regulating both, the launch of products in addition to stipulating guidelines with respect to an appro-priate use of biocidal products.

The potential use of biocidal products is described in Annex V of Regulation No 528/2012, divided into 4 main groups as follows:

1. Disinfectants and general biocidal products

2. Preservatives

3. Pest control

4. Other biocidal products, such as anti-fouling products.

Biocides

Our Services:

; Efficacy tests

; Stability tests

; Chemical studies

; Toxicological studies

; Ecotoxicological studies

We take care:

+49 40 49294-6830careproducts@eurof ins.de

Nora Veidt, Nicole Forstner, Susanne Brauer, Peter Kracht, Zorica Jovanovic, Gerrit Uhe, Linda Raschdorf, Anika Lippert

Cosmetics – Hygiene Detergents – Biocides

Compliance WorkFood Contact

Our Services:

; Comprehensive analyses:

• Overall migration (OML)• Specific migration (SML)• Sensory analysis• NIAS screening

; Declarations of Compliance

; Systematic test plan generation

; Worst-case calculations

; Toxicological risk assessment

; Compliance Manager Software

Your Challenge:The European Framework-Regulation (EC) No 1935/2004 gives general requirements for all food-contact-materials in Article 3 and points to further (material-specific) measures such as the GMP-Regulation (EC) No 2023/2006 or the Plastics-Regulation (EU) No 10/2011. Accordingly, materials and articles for food contact may not change food unacceptably with regards to their organoleptic properties (taste, smell, colour), their composition (overall migration) and need to be manufactured with constant quality from traceable raw materials (GMP). Most importantly, human health may not be endangered (SML, NIAS).

Compliance with these general and material-specific requirements needs to be proven by the manufacturer. According to Article 15 of the Plastics-Regulation the manufacturer or first-importer into the European Union needs to issue a written Declaration of Compliance (DoC), stating that the respective material or article for food contact fulfils all require- ments of the above-mentioned regulations.

Your Challenge:

The European Plastics-Regulation (EU) No 10/2011, as a material-specific requirement, limits the trans-fer (migration) of substances from the packaging into the food. As a general quality criterion, the sum of all migrating substances (overall migration, OML) is limited to 60 mg/kg food irrespective of their nature and toxicology. In addition, Annex I contains a positive-list for approved substances for the manufacture of plastic articles for food contact, the so-called ‘Union-list’. These substances are listed there with individual limits for their migration into food based on their respective toxicology. These specific migration limits (SML) are often much lower than the OML.

The Plastics-Regulation is also very detailed about the conditions for migration testing with respect to e.g. food simulants, temperatures and durations. However, apart from the actual analytical testing other means to prove compliance are also accepted. These could be e.g. worst-case calculations, model-ling, or other scientific reasoning.

Migration TestingFood Contact

Our Services:

; Raw material datasheet retrieval

; Comprehensive analyses:

• Overall migration (OML)• Specific migration (SML)• Sensory analysis• NIAS screening

• Microbiology

; Declarations of Compliance

; Consultancy & training

Your Challenge

The positive-list in Annex I of the European Plastics- Regulation (EU) No 10/2011 lists monomers and ad-ditives as approved substances for the manufacture of plastic-articles intended for food-contact.

Such raw materials, in turn, might contain impurities or degradation products originating in their manu-facturing or degradation processes. These substances, however, were not added intentionally into the finished article (NIAS, non-intentionally added substances).

In case they are relevant for the risk-assessment, the main impurities of approved substances need to be considered in the approval process and, if neces-sary, included in the specification of the respective raw material. On the other hand, it is impossible to list all potential NIAS and consider them in the approval process.

Due to this reason they might be present in the material or finished article, although they are not listed in the Union-list, and could migrate into the food.

According to Article 19 of the Plastics-Regulation potential health hazards by NIAS from finished articles need to be covered by their manufacturer according to internationally recognised scientific principles for risk-assessment.

NIAS & Risk-AssessmentFood Contact

Our Services:

; NIAS Screening

; Toxicological risk assessment

; Declarations of suitability

; Scientific statements

; Contact with enforcement authorities

; Consultancy & trainings

Your Challenge:

So far, there is no harmonised legislation in the European Union for printing inks for food-contact- materials. In spite of some national legislations, mainly non-binding recommendations such as the guideline from the European Printing Ink Association (EuPIA) or the Council of Europe resolution AP (89) 1 provide important requirements for printing inks and pigments for food-contact-materials.

By measuring the migration of printed food pack-aging the extent of the exposure of consumers to specific components from printing inks can be determined such as photoinitiators, acrylates or solvents. This so-called specific migration would also be the reason for objections by authorities.

Most substances used in the manufacture of print-ing inks are not regulated, yet, so a low migration limit of only 0.01 mg/kg food applies per default. Certain pigments could even react to carcinogenic primary aromatic amines (PAAs), that may not exceed an even lower limit value of only 0.002 mg/kg food.

Printing Inks Food Contact

Our Services:

; Content determinations

; Migration testing

• Photoinitiators• Acrylates

• Primary Aromatic Amines (PAAs)

; Pigment analysis

; Sensory analysis

Food Contact Materials

We take care:

+49 40 49294-6840migrat ion@eurof ins.de

Renate Eschen, Dr. Andreas Grabitz, Birthe Gallhof, Janina Welz, Dr. Anil Berger, Maciej Dalmann, Ludmila Schneider

Your Challenge:

According to the 2nd regulation regarding the German product safety law and following the EU toy regulation (EC) No 2009/48, the general principle of not presenting any risk of health to consumers applies. Toys are defined as products - exclusively or not - intended to be used in play. Therefore, it is not sufficient to just fulfil the require- ments of the EN 71 norm series, but, depending on the type of the toy and the materials used, further regulations apply.

Our experts are available for you at any time and will be pleased to guide you through the regulations. Depending on your requirements, whether you are less risk oriented or you rather have an eye on the cost, we will create a test plan tailored to your needs, and reports are typically issued to you within 5 working days for most standard tests.

Toys

Our Services:

; Detailed advice by our experts

; Complete test range for chemical, mechanical and microbiological requirements

; Central project management in Germany for testing in Asia and USA

; Personal consulting & training

; Site inspections

; Certifications

Our Services:

; Detailed advice by our experts

; Complete test range for chemical, mechanical and microbiological requirements

; Fit for use testing

; Central project management in Germany for testing in Asia and USA

; Personal consulting & training

; Site inspections

; Certifications

Your Challenge:

Definitions for consumer products are widely found, for example within the German LFGB (§2). Those definitions are rather loose and cover a wide range of products of articles of daily use.

Amongst them are jewellery, textiles, accessories, marketing items, household appliances etc. For many of these products, only vague legal require-ments apply. More often there are market and client specific requirements to be considered.

We help you understand those and define a test plan cut to your needs.

Consumer Products

Your Challenge:

Components in contact with food are rather strictly regulated items within the group of general consumer products. Especially plastic items are regulated in detail, but there are requirements also for ceramics, metals and wood with existing limits. Keeping the overview is not always very easy, especially if one has to keep the cost in mind.

Consumer Products Food Contact Materials

Our Services:

; Detailed advice by our experts

; Complete test range for chemical, mechanical and microbiological requirements

; Sourcing of required information directly from the producers

; Assistance in issuing the declaration of conformity

; Fit for use testing

; Central project management in Germany for testing in Asia and USA

; Personal Consulting & training

; Site inspections

; Certifications

We take care:

+49 40 49294-6850products@eurof ins.de

Denis Campbell, Cora Braun, Martina Alex

Toys - Consumer Products

Eurofins Consumer Product Testing GmbH Am Neuländer Gewerbepark 4 21079 Hamburg Germany

+49 40 49294-6900

careproducts@eurofins.de migration@eurofins.de products@eurofins.de

Eurofins Consumer Product Testing GmbH

We take care:

The Laboratory Team