Identification of the roles and obligations of downstream users

The strategic objectives of the regulation aim to increase awareness of the risks of using chemicals (particularly hazardous ones), to ensure a high level of protection of health and environment, to promote the free movement of chemical substances as such, or in preparations and articles, to promote competitiveness and innovation, and, finally, to encourage the substitution of dangerous substances with less hazardous ones.

The introduction of the precautionary principle of REACH, places on the industry the burden of proving the not harmful characteristics of chemical substances before marketing (in the past they could be used until the Public Authorities showed that they were harmful); the regulation requires that the substances must be examined to identify potential risks; the regulation also requires, if possible, the immediate replacement of substances of very high concern, or to establish research programs for the development of their future replacement.

The organization identifies as national authorities the Ministries of Labor and Health, and identifies the agencies responsible for monitoring, which, among others, are N.A.S. and N.O.E., ISPESL, Customs Agency, and others in discovery phase.

After noting that the REACH Regulation should be respected along with CPL, the hygiene and safety in the workplace, and environmental protection standards, Dr. Borillo examines the Supply Chain, which consists essentially of three large rings :

1) Importer and Manufacturer / Producer;
2) Distributor and Retailer;
3) downstream users = Subjects that exercise their activities, professional or entrepreneurial, using a substance as such, or as a preparation, or in an article [Roles: Preparations Formulators, Fillers, Importers from foreign suppliers as exclusive representatives, Reimporters, End-Users (industrial user, producer of articles, craftsmen, workshops, service providers, suppliers).]

Before going to examine in detail the different roles of the downstream users, Dr. Borrillo recalls the following definitions:

Substance = element, or its compound, in the natural state, or obtained by manufacture, including additives and impurities, but excluding any solvent which may be separated without affecting its stability or changing its composition;
Preparation = mixture / solution of two or more substances;
Article = object which is given, during manufacture, shape, surface or design which determines its function more than its chemical composition.

The "Formulator of Preparations” is the entity who:
 Mixes substances and / or preparations to make preparations to enter the market without chemical reactions taking place (mixing with chemical reaction is considered manufacturing, and therefore subject to registration);
 dilution of substances in water;

The "Filler” is the person who makes the transfer of substances and / or preparation from one container to another, even if it gives a new label to the final product at the time of filling (in this case assumes the role of" Repackager ");

The "Re-importer" is the person who imports substances and / or preparations originally produced in EU countries by foreign suppliers;

The "Importer from foreign suppliers with exclusive representative “ is the person who carries out import of substances and / or preparations from a distributor settled outside the EU who is designated a "sole representative" that assumes the responsibilities related to imports of the substance and / or preparation [one can buy directly from foreign supplier (after making sure it has appointed the exclusive representative), or by the exclusive representative thereof]

The 'End User "is the person who makes use of substances and / or preparations in an industrial and / or professional environment (other than the consumer, or the distributor) without providing them to other users down the supply chain.

The end user can assume further different names:
 The end user assumes the name of Manufacturer of Articles if the substance / preparation is integrated in an article and is not considered supplied to downstream end users;
 The end user assumes the name of Craftsmen, or Laboratory or Provider of professional services, if the substance and / or preparation is used in professional activities not classified as industrial process/use (even without a workplace or a laboratory);
 The end user assumes the name of Industrial User if the substance or preparation is used as a processing aid in an industrial process.

After having examined the ROLES, Dr. Borrillo examines the OBLIGATIONS of DOWNSTREAM USERS, which can be summarized as follows:

 The downstream user does not have, in general, the registration requirements;
 cannot enter in the market substances that have not been pre-registered / registered by the supplier in accordance with the REACH Regulation;
 must make sure that the supplier is aware of, and complies with, their obligations under the regulation, not only by obtaining a declaration, but also obtaining from
the supplier a confirmation that the registration procedure has been completed, or is in progress ;
 must implement measures to manage the risks inherent to the use of the substance as defined by the technical booklet and Safety Data Sheet (SDS) complete scenarios of exposure (SE), following the chemical safety assessments (CSA), where required;
 must receive from customers, and communicate to the supplier, information on the utilization of the substance to ensure that such employment is covered in the technical booklet (activate the supply chain);
 must submit recommendations for risk management to the downstream users (customers);
 must ensure that the SDS is inclusive of all the information received from the suppliers of the components (CH substances), if a preparation is formulated;
 must notify the supplier if aware of information that challenges the information pertaining to the management of risk / danger received by it.

In summary Dr. Borriello clarifies that the downstream user is not subject to registration or to notification if:
a) all of the suppliers are located within the European Economic Area (EEA);
b) their suppliers have appointed an exclusive agent;
c) the downstream user does not produce any substance / preparation / new article.

In conclusion he emphasizes that if the downstream user is using substances subject to authorization, must:
a) respect the conditions of use specified in the authorization for that specific use by the supplier;
b) apply for permission to ECHA if the supplier's authorization does not cover the intended use;
c) notify ECHA of the use of the substance within 3 months after first delivery.

Finally, if the downstream user uses a substance outside the conditions laid down in the SDS shall:
a) adjust the conditions of use to those described in the SDS;
b) implement a SE that includes at least the conditions described in the SE statement received from the supplier;
c) disclose the use to the supplier with the objective that the use is identified on the basis of the chemical safety assessment performed by the manufacturer;
d) develop their own chemical safety assessment for that specific use, insert it into the chemical safety report, and notify ECHA if the quantity is> 1 T / a;
e) turn to another supplier that covers its use in its Material Safety Data Sheet.