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Regulatory Areas

Reagenzgläser

Toxicological safety / risk assessment

We assess potential risks from chemicals to human health in a wide range of products

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Cosmetic products

  • Preparation and maintenance of Product Information File (PIF) including preparation of Cosmetic Product Safety Report (CPSR);

  • Human toxicological safety assessment of ingredients according to guidance provided by the Scientific Committee on Consumer Safety (SCCS);

  • Review and compliance of INCI names;

  • Conformity check of the marketability of the formulations and safety instructions on the packaging according to Regulation (EC) No. 1223/2009 on cosmetic products;

  • Notification to the cosmetic products notification portal (CPNP)

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Consumer Products

  • Safety assessment of various consumer product products, which have a direct or indirect contact with the human body (i.e. hygiene products) or their ingredients, to comply with relevant national, European, and global regulations;

  • Toxicological safety assessment based on a product specific exposure scenario (e.g. using modelling tools like for example ConsExpo etc.);

  • Advice on claims, precautionary statements, and labelling;

  • Preparation of safety reports.

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Detergents

  • Ensuring compliance with EU Detergents Regulation (EC No. 648/2004) and its amendments;

  • Safety assessment of ingredients based on appropriate exposure scenario;

  • Preparation of expert statement and safety reports

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Food, novel food and food supplements

  • Toxicological risk assessment of contaminants in food products;

  • Support by authorization and safety assessment of novel food according to the Novel Food Regulation (EU) 2015/2283;

  • Safety assessment of food supplements accordingto the harmonised rules of Directive 2002/46/EC

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Food/Feed additives

  • Support by safety assessment and authorisation process.

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Food contact materials

  • Toxicological risk assessment of migrating substances from food contact materials (FCM);

  • Migration calculation;

  • Compliance assessment according to EU Regulation (EC) No 1935/2004 and to Recommendations of the (German) Federal Institute for Risk Assessment (BfR).

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Packaging materials

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Medical devices

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Industrial chemicals

  • Regulatory and scientific support by registration of chemicals in the EU;

  • Dossier preparation according to REACH (EC) 1907/2006 Regulation (IUCLID file, Chemical safety Report);

  • Support in communication with authorities.

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Biocides

  • Preparation of dossiers according to Biocidal Products Regulation No 528/2012 for active substances and biocidal products;

  • Support and guiding by authorization process;

  • Communication with the competent authorities in the EU.

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Plant protection products and agrochemicals

  • Preparation of dossiers according to Regulation (EC) No 1107/2009 for plant protection active substances and products based on data requirements of Regulations (EU) No 284/2013 and Regulation (EU) No 284/2013;

  • Human and animal exposure and risk assessments for various agrochemicals (e.g. nitrification inhibitors or fertilizers).

  • Hazard and exposure evaluation and risk assessment of compositional substances and extractables or leachables, including packaging
    from recycled materials for variety of products including cosmetic products and pharmaceutical preparations;

  • Ensuring compliance with Regulation (EC) No 1935/2004, Regulation (EU) 10/2011 and Regulation (EU) 2022/1616;

  • Preparation of a document on

  • biological/toxicological safety assessment including biocompatibility according to Regulation (EU) 2017/745 and ISO 10993 series;

  • Toxicological assessment of compositional substances of a critical substance

For more information, please refer to website of our partner ATC GmbH (Applied Tox-Consult):

Starilux S.a.r.l.

We are Starilux S.a.r.l. - an established company offering a wide range of services to help companies meet regulatory challenges. Starilux S.a.r.l. is committed to helping their customers comply with regulations and minimize risks while enabling smooth business operations.

You take care of your business - we take care of the regulatory hurdles!
Starilux contact

Rue Roger Streff 7

6619 Wasserbillig

Luxemburg

Distribution and support:

+49-172 6883 929

Regulatory affairs:

+49-174 964 0150

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