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Questions and answers

The Consolidated Law on Worker Safety is a set of rules of the Italian Republic on health and safety at work, issued with Legislative Decree 81/2008 and integrated with the corrective decree n.106 / 2009. Legislative Decree 81/2008 reformed, assembled and harmonized by repealing the provisions dictated by numerous previous regulations on safety and health in the workplace in the course of almost sixty years, in order to adapt the regulatory body to the evolve the technique and the work organization system.

The employer must prepare all the necessary measures to protect the health and safety of workers who carry out any activity within the company; he must therefore assess the risk factors, designate the Head of the Risk Prevention and Protection Service (RSPP) and deal with the preparation of the Risk Assessment Document. It is then required to ensure adequate training for all workers on firefighting, first aid and emergency management.

Yes, and must be formed within 2 months of starting the activity.

“Worker”: a person who, regardless of the type of contract, carries out a work activity within the organization of a public or private employer, with or without remuneration, even for the sole purpose of learning a profession, an art or a profession, excluding domestic and family workers. The worker thus defined is equivalent to: the cooperative or company worker member, even de facto, who carries out his activity on behalf of the companies and the body itself; the associated member referred to in Article 2549 (N), and following of the Civil Code; the beneficiary of the training and orientation internship initiatives referred to in Article 18 of the Law of 24 June 1997, no. 196 (N), and referred to in specific provisions of the regional laws promoted in order to create moments of alternation between study and work or to facilitate professional choices through direct knowledge of the world of work; the student of the educational and university institutes and the participant in the professional training courses in which laboratories, work equipment in general, chemical, physical and biological agents are used, including the equipment provided with video terminals only for the periods in which the student is actually applied to the equipment or laboratories in question; volunteers from the National Fire Brigade and Civil Protection Corps; the worker referred to in Legislative Decree 1 December 1997, n. 468 (N), and subsequent modifications.

High risk: 48 hoursHigh risk: 14 hours
RSPP EMPLOYERMedium risk: 32 hours90 days from the opening of the businessIf appointed by January 26, 2017, within 5 years of basic trainingMedium risk: 10 hours
Low risk: 16 hoursLow risk: 6 hours
RLS32 hoursFollowing the appointment of RLSEvery yearUp to 50 workers: 4 hours
Over to 50 workers: 8 hours
MANAGER16 hoursWithin 60 days of taking officeWithin 5 years from the basic training of the Manager6 hours
High risk: 16 hours
WORKERMedium risk: 12 hoursPrima dell'esposizione ai rischi e comunque entro 60 giorni dall'assunzioneEntro 5 anni dalla formazione generica e specifica6 hours
Low risk: 8 hours
SUPERVISOR8 hoursBefore exposure to risks and in any case within 60 days of hiringWithin 5 years from the basic training of the Supervisor6 hours
High risk: 16 hoursHigh risk: 8 hours
FIRE FIGHTERMedium risk: 8 hoursAt the time of the appointmentWithin 3 years of the basic courseMedium risk: 5 hours
Low risk: 4 hoursLow risk: 2 hours
Gruop A: 16 hoursGruop A 6 hours
FIRST AID OFFICERGruop B: 12 hoursAt the time of the appointmentWithin 3 years of the basic courseGruop B 4 hours
Gruop C: 12 hoursGruop C 4 hours
SCAFFOLDING ASSEMBLY AND DISASSEMBLY28 hoursAt the time of the appointmentWithin 4 years of basic training4 hours
SECURITY COORDINATOR120 hoursAt the time of the appointmentWithin 5 years of basic training40 hours


Questions and answers

For most REACH, CLP and BIOCIDE processes the following information must be included in the dossiers to clearly identify the substance:

  • Name of the substance and related identifiers (IUPAC name, EINECS or ECLINS no. And CAS no.).
  • Molecular and structural formulas.
  • Information on the composition and purity of the substance.
  • Spectral data and other analytical information to verify the identity and composition of the substance.

All chemicals produced or imported into the EU in quantities above 1 ton / year, both as such and if contained in mixtures, must be registered.

The only substances that do not need to be registered are:

  • Polymers
  • Substances included in Annexes IV and V of the Reach Regulation
  • Radioactive substances
  • Substances subject to national exemption in the interest of defense

Furthermore, it is not necessary to register substances that are used exclusively:

  • As non-isolated intermediates
  • For research and development activities
  • In food or feed
  • In medicines
  • In biocidal or plant protection products as active ingredients.

However, if these substances are used for other purposes, it will need to be registered for those uses.

By virtue of their origin and their history, they are not subject to the registration obligation:

  • Substances already registered
  • Substances subject to customs control
  • Waste

The Reach Regulation defines “polymer”:

A substance whose molecules are characterized by the sequence of one or more types of monomer units; such molecules must be distributed over a range of molecular weights where the differences in molecular weight are mainly attributable to differences in the number of monomer units.

Polymers are not subject to registration, however monomers and other substances used for the manufacture of the polymer may be subject to the registration obligation.

In particular, monomer substances will be subjected to simplified registration procedures only if all three of the following conditions are met at the same time:

  1. They have not already been registered
  2. Are present in the polymer by weight> 2%
  3. In quantities of at least 1 ton / year of monomer

SVHC substances – Substances of Very High Concern – are substances identified by the Reach Regulation (Article 57) as extremely worrying:

  • Substances that meet the classification criteria as carcinogenic, mutagenic or toxic for reproduction (categories 1° or 1B under the CLP Regulation).
  • Persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) substances – Annex XIII of the Reach Regulation.
  • Substances identified on a case-by-case basis, giving rise to a level of concern equivalent to CMR or PBT / vPvB substances.

The substances identified as extremely worrying are included in the “Candidate List”.

When an SVHC substance is included in the Candidate List, certain legal obligations arise for companies that manufacture, import or use these substances in the EU.

REACH-IT is the central IT system available to industry, the competent authorities of the Member States and the European Chemicals Agency, to present and manage data and dossiers safely. Each of these three subjects has access to specific REACH-IT functions useful for fulfilling the obligations under the regulations. REACH-IT also provides a secure communication channel between the aforementioned parties to help them coordinate the processing and evaluation of data and dossiers.

The CLP regulation requires manufacturers, importers and downstream users of substances or mixtures to classify, label and package hazardous chemicals appropriately before placing them on the market. Once a substance or mixture has been classified, the identified hazards must be communicated to other actors in the supply chain, including consumers.

The notification obligation provided for by the CLP regulation requires manufacturers and importers to transmit information relating to the classification and labeling of substances they place on the market to the C&L inventory held by ECHA.

All biocidal products require an authorization before they can be placed on the market; in addition, the active ingredients contained in them must have been previously approved.

A polymer is a substance whose molecules are characterized by the sequence of one or more types of monomer units. According to the REACH Regulation, a polymer is a substance that meets the following criteria:

  • More than 50% of the weight of this substance consists of polymer molecules containing at least three monomer units having a covalent bond with at least one other monomer unit or another reagent.
  • The quantity of polymer molecules having the same molecular weight must be less than 50% of the weight of the substance.

If the robust study summary has already been submitted to ECHA, a subsequent registrant may refer to that study in his dossier, provided that he has permission to do so. In this context, the registrant and the owner of the data must agree on the conditions that entitle them. The Letter of Access (LoA) is a term often used to describe the agreement on data sharing and the granting of the right to refer to such data. However, the intellectual property rights of the data owner must be respected by the potential registrant.

In South Korea, chemicals are regulated by the Korean Chemical Control Act (CCA). Under Article 9 of the CCA, anyone intending to manufacture or import a chemical must confirm whether the substance is regulated by submitting a written confirmation of the details for each chemical to the KCMA (Korea Chemicals Management Association) prior to production or import.

The written confirmation can be a Confirmation Letter (LOC) which provides the details of the chemicals, in particular it is necessary to specify if the substance is regulated, i.e. if it is included in one of the following lists:

  • Phase-in substances for registration (PEC substances required for registration with K-REACH)
  • Non phase-in substances (new chemicals required for registration in K-REACH)
  • Toxic substances
  • Substances subject to authorization
  • Restricted substances
  • Prohibited substances
  • Chemicals for accident prevention

The Turkish Reach provides for the PRE-REGISTRATION and then the REGISTRATION of all chemical substances, both as such and if contained in mixtures, produced or placed on the Turkish market for an annual volume> 1 ton. On the other hand, as regards chemicals classified as dangerous, these must be notified regardless of the quantity.

If over one tonne and dangerous chemicals will then be subject to both registration and notification.

As regards the SDSs, in accordance with the SEA Regulation (aligned with the European CLP), these must be prepared by a person who has obtained certification as an SDS preparatory expert in accordance with Turkish standards. Attached I am also sending you our quote for drafting and support services for SDS in accordance with Turkish regulations.