Scope and Exemptions of REACH Regulations in Italy

The Ital­ian cen­tral admin­is­tra­tion has been work­ing to enforce reg­u­la­tions on the trade and activ­i­ties con­cern­ing chem­i­cal sub­stances and mix­tures since the late 1970’s.

How­ev­er, with the intro­duc­tion of REACH by the Euro­pean Chem­i­cal Agency in 2007, a more com­plex approach to the enforce­ment and man­age­ment was put in place. In order to coor­di­nate and ensure the ful­fill­ment of REACH reg­u­la­tions in Italy, a new gov­ern­ing body was formed head­ed by the Min­istry of Health: the REACH tech­ni­cal committee.

Present­ly, the Ital­ian importers are required to reg­is­ter for REACH in addi­tion to ful­fill­ing oth­er import doc­u­men­ta­tions. As such, the US chem­i­cal com­pa­nies trad­ing in Italy are expect­ed to appoint a REACH Only Representative.

To release importers of the reg­is­tra­tion oblig­a­tion and con­duct busi­ness smooth­ly. In this post, we will dis­cuss the scope and exemp­tions of REACH reg­u­la­tions in Italy which sub­stances, mix­tures or prod­ucts come under the REACH reg­u­la­tions to ensure com­plete compliance.

Scope of REACH Regulations

Most of the chem­i­cals sub­stances that are man­u­fac­tured, placed on the mar­ket or sim­ply used with­in the EU fall into the scope of REACH. These may be ‘sub­stances on their own’, used in mix­tures or as part of oth­er arti­cles. The low­er thresh­old for reg­is­tra­tion require­ment is 1 ton per year per registrant.

How­ev­er, there are oth­er oblig­a­tions under REACH that apply to cer­tain sub­stance man­u­fac­tured in the EU or import­ed even if the vol­ume is less than 1 ton per year.

These oblig­a­tions are con­cerned with the use of the sub­stance, restric­tions, and autho­riza­tion, and hence reg­u­la­tion is applic­a­ble irre­spec­tive of their volume.

REACH reg­u­la­tions also applies to sev­er­al sub­stances occur­ring in nature. How­ev­er, if those sub­stances are not chem­i­cal­ly mod­i­fied, they might be eli­gi­ble for exemp­tion under REACH.

Exemptions from REACH Regulations

The rules and reg­u­la­tions of REACH apply to all the chem­i­cal sub­stances with the few exemp­tions- sub­stances under the cus­tomized super­vi­sion, non-iso­lat­ed inter­me­di­ates, and the var­i­ous radioac­tive substances.

Waste is also an exempt­ed prod­uct as it is not a prepa­ra­tion or an arti­cle with­in the mean­ing of REACH.

Sub­stances such as car­bon diox­ide, water, and oth­er organ­ic sub­stances like veg­etable oils, cel­lu­lose pulp, and fat­ty acids etc, need not be reg­is­tered under REACH.

Also, the sub­stances used for R&D, bio­cides and plant pro­tec­tion prod­ucts, food and food addi­tives and the sub­stances recov­ered in the EU do not to be reg­is­tered again.

CAPLINQ offers reli­able REACH Only Rep­re­sen­ta­tive ser­vices to US chem­i­cal com­pa­nies plan­ning to expand in Italy and oth­er Euro­pean Union coun­tries. To learn more about our REACH Ser­vices you can vis­it www.caplinq.com or con­tact us direct­ly to learn all about REACH Regulations.