Bio-/PharmaceuticalsMedical DevicesChemicalsAgrochemicals & BiocidesCosmeticsFoodRaw Materials Testing

Global Safety Testing Services for:Eurofins BioPharma Product Testing Munich GbmHBehringstraße 6/8D-82152 Planegg/MunichPhone: +49 89 89 96 50-0Fax: +49 89 89 96 50-11

Facility: info-munich@eurofins.com

www.eurofins.com/reach-services

Testing Services for Industrial Chemicals / REACH

Eurofins is a global service provider to the Chemical industry, offering a comprehensive range of testing and consultancy services for REACH as well as for worldwide registrations. We are backed by a large team of experienced scientists and regulatory specialists that are available to support you with all steps of the regulatory process under REACH. This includes both phase-in and the non-phase-in substances.

The REACH Regulation (EC) No 1907/2006 became effective June 1, 2007 creating a single registration system for both new and existing chemicals in Europe. The main objectives of REACH are to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry.

The upcoming deadline 2018 for substances over 1 t/a (phase 3 substances) covers less widely used substances and it is likely that less data will already be available to fulfill the REACH requirements. Therefore we encourage our clients to start planning at an early stage to ensure labora-tory and regulatory capacity.

Due to a large variety of chemicals tested for the REACH deadlines in 2010 and 2013 we are well prepared to effec-tively support you also for the 2018 deadline as well as for registrations outside the EU.

Profile of Services for Chemicals:

Full portfolio according to Annex VII-X of the REACH directive

•Physicochemical Properties

•Toxicology

– Skin irritation / corrosion (in vitro / in vivo)

– Eye irritation / corrosion (in vitro / in vivo)

– Sensitization

– Genetic Toxicology

– Acute Toxicity

– Repeated Dose Toxicity

– Developmental and Reproductive Toxicology (DART)

– Toxicokinetic Studies

– Carcinogenicity

– Endocrine Disruptors

•Ecotoxicology

– Aquatic Toxicology

– Terrestric Toxicology

– Biodegradation

– Environmental Behavior

•Analytical Services

•Consulting Services

Besides the standard testing battery we offer individual advice concerning your specific project with regard to scientific and regulatory requirements. These customized test designs include neutotoxicity and immunotoxicity testing to address specific safety concerns.

In vivo studies will be conducted in cooperation with BSL BIOSERVICE Scientific Laboratories Munich GmbH, a preferred partner of Eurofins.

Animal Facility

BSL BIOSERVICE Scientific Laboratories Munich GmbH is an internationally active Contract Research Organization (CRO).

Our state of the art in vivo laboratories have been ap-pointed as “Gold Standard” by the Bavarian State.

The highly standardized climatic and hygienic environ-ment forms a sound basis for the reliable safety assess-ment of test substances.

Rooms and Laboratories

• Capacities for between 7,000 and 25,000 small labora-tory animals (depending on species)

• 24 rooms for animal husbandry

• 9 modern laboratories and operating rooms

Hygiene

• HEPA filter

• Aerosol particle filter

• Air showers for material

• VHP (vaporized hydrogen peroxide) decontamination of material and rooms

• Drive through autoclave

• Fully automated cage cleaning system

Optimal Service for Research

• AAALAC and ISO accredited facility

• GLP certified

• Animals only from selected breeders

• Extensive clinical examinations and /or laboratory diagnostic analyses of every animal

• A well trained staff of veterinarians and animal care keepers

• Anesthesia carried out by experienced veterinarians

• Surgical preparation and assistance dur-ing the surgery by trained personnel

• Performance of the surgery by an experi-enced surgeon

• Comprehensive documentation of all findings during the course of the study

• Experimental protocols reviewed by BSL internal Ethics Committee and accepted by governmental competent authority. Study monitored by independent animal welfare officer

BSL BIOSERVICE Scientific Behringstraße 6/8 Phone +49 89 89 99 74 9-0 info@bioservice.comLaboratories Munich GmbH 82152 Planegg/Munich Fax +49 89 89 99 74 9-25 www.bioservice.com Germany

www.bioservice.com

Cage Systems

• Individually ventilated caging systems (IVC’s) with a unique facility infrastructure (physical and mechanical)

• Positive / negative control IVC racks

• Conventional open housing

Technological Features

• Clean-room components

• Optimal solutions for airconditioning techniques

• Continous reading of 1,450 electronical data points

• 4 pressure differentials

• Various levels of filter fan units

• Lead through for media

• Emergency backup generator

The Advantages

• Extremely low number of spontaneous inflammatory infiltrates

• Safe housing of immunodeficient animals

• Clear phathological data

• Reliable and stable in vivo data

partner of

www.safety-alliance.net