ARCHIMEDE R&D ooffers consultancy and training services to companies that produce, import or resell substances or mixtures and that produce or import items, in order to adapt the products to the Italian, European and international regulations in chemical and related fields.

Adaptation to standards will allow our Clients to obtain product dossiers suitable for all the markets in which they are interested in proposing their solutions.

Assistance and training services are customised according to the company’s needs, with the aim of ensuring that products and/or processes comply with current laws and regulations, with a view to efficiency. On this page you will find our main areas of intervention.

Reach

EC Regulation no. 1907/2006 and subsequent amendments and additions

  • Company audits to verify compliance with the Regulations with respect to the activity carried out
  • Verification of the necessary documentation and communication within the supply chain
  • Verification of the presence of SVHC substances, subject to authorisation or restriction and their management
  • Waste recovery management
  • Registration of substances according to tonnage/year:
    • Communication management with Lead Registrant
    • Support in the analytical identification of the substance (sameness)
    • Registration Dossier Processing on IUCLID
    • C&L notification
    • Risk Assessment and Chemical Safety Assessment (CSA)
    • Chemical Safety Report (CSR)
  • Registration Dossier Update
  • ECHA Inquiry
  • Communication with the competent authorities (Italian and European)
  • Safety Data Sheets (in Italian and European languages) according to EU Reg. n. 2015/830

CLP

EU Regulation no. 1272/2008 and subsequent amendments and additions:

  • Substance and mixture classification
  • CLP label design
  • Support for correct labelling and packaging
  • C&L notification according to art. 40 on hazardous substances manufactured in the EU or imported from countries outside the EU.
  • UFI and notification to the ECHA portal according to art. 45, harmonisation of the information to be communicated to the Competent Bodies. Annex VIII of CLP (Reg. (EU) 2017/542).

Biocidi

EU Regulation no. 528/2012 and subsequent amendments and additions:

  • Technical-statutory assistance in the application of the Regulation  
  • Support with the definition of business objectives
  • Consultancy for the preparation of the application for authorisation

P.M.C.

Italian acronym for Medical Surgical Devices:

  • Consultancy for the preparation of the application for authorisation from the Ministry of Health and the ISS (Italian Institute of Health)
  • Consultancy for application for authorisation as a Production Laboratory

Detergenti

EU Regulation no. 648/2004 and subsequent amendments and additions:

  • Support for correct labelling
  • Drafting of Ingredient data sheets and their management
  • Notification of the composition of the mixtures to the ISS Hazardous Preparations Archive according to Italian Legislative Decree No. 21/2009

Preparati pericolosi

HAZARDOUS PREPARATIONS (Italian Legislative Decree No. 65/2003):

  • Notification of the composition of the mixtures to the ISS (Italian Institute of Health) Hazardous Preparations Archive  

Altre normative specifiche

  • VOC (Volatile Organic Compounds)
  • RoHS II (Dir. 2011/65/EC on the restriction of the use of certain hazardous substances in electrical and electronic equipment)
  • MOCA (Food Contact Materials)

Corsi di formazione

Our training courses are organised with the aim of providing companies with the necessary tools for industrial management of chemical regulations. We believe that an efficient use of time is a valuable resource and therefore each course is tailored to the Client’s needs. The topics of our training courses are:

  • REACh (EC Reg. no. 1907/2006 and subsequent amendments and additions)
  • CLP (EC Reg. no. 1272/2008 and subsequent amendments and additions)
  • Biocides – Medical and Surgical Devices (PMC) – European and National Legislation

Each course includes the analysis of a company-specific case study in order to give practical evidence of the topics covered during the training.

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