The ALLTUB Group has expertise in regulatory compliance.

The ALLTUB Group produces collapsible tubes, aerosol cans and cartridges made from virgin, PIR or PCR aluminium as well as collapsible tubes made from plastic laminates with aluminium or plastic barriers.

Our products are used as primary packaging in the pharmaceutical, cosmetic, food and industrial markets.

REACH

The ALLTUB Group is a downstream user and manufacturer of articles in the meaning of the European chemical legislation REACH (Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals).

We exclusively process at our European sites raw materials, which comply with the REACH Regulation including the CLP Regulation (EC) No 1272/2008 (Classification, labelling and packaging of substances and mixtures), and we fulfil all REACH obligations as applicable to packaging manufacturers.

The ALLTUB Group strongly avoids using raw materials containing more than 0.1% by weight of Substances of Very High Concern (SVHC) published to the Candidate List for Authorisation according to Article 59(10) of REACH. However, we will fulfil the REACH obligations to submit relevant data to ECHA via the SCIP database and will inform our customers, if different.

Heavy Metals (PPWD)

ALLTUB products comply with the European Packaging and Packaging Waste Directive 94/62/EC concerning the defined limits for heavy metals (Sum of Cd, Cr, Hg and Pb < 100 ppm).

Furthermore, we can supply packaging products for the aforementioned markets, which are made from materials fulfilling the specific requirements per application as following:

Pharmaceutical Packaging

  • Virgin, PIR, PCR Aluminium -> EU FC, EN 602
  • Internal varnishes ->EU FC
  • Laminates (ABL + PBL) -> EU FC, EP
  • Plastic parts (shoulders, threads, cannulas, caps) -> EU FC, EP
  • Top seals -> EU FC, EP
  • Colorants -> EU FC

Regulatory information letters based on defined tube specifications can be provided on request -> RI for Pharma

Cosmetic Packaging

  • Virgin, PIR, PCR Aluminium -> EU FC, EN 602
  • Internal varnishes -> EU FC, EU CR
  • Laminates (ABL + PBL) -> EU FC, EU CR, EP
  • Plastic parts (shoulders, threads, cannulas, caps) -> EU FC, EU CR, EP
  • Top seals -> EU FC, EU CR, EP
  • Colorants -> EU FC

Regulatory information letters based on defined tube specifications can be provided on request -> RI for Cosmetic

Food Packaging

  • Virgin, PIR, PCR Aluminium -> EU FC, EN 602
  • Internal varnishes -> EU FC, EU CR
  • Laminates (ABL + PBL) -> EU FC, EU CR, EP
  • Plastic parts (shoulders, threads, cannulas, caps) -> EU FC, EU CR, EP
  • Top seals -> EU FC, EU CR, EP
  • Colorants -> EU FC
  • Tube -> Doc

Regulatory information documents based on defined tube specifications can be provided on request -> EU FC DoC

Industrial Packaging

RoHS, POP, PFAS, CMR

Regulatory information letters based on defined tube specifications can be provided on request -> RI for Industrial.

Legend

EU FC = Compliance with EU Food Contact Legislation including Framework Regulation 1935/2004, GMP Regulation 2023/2006 and, as applicable, CoE Resolution CM/Res(2013)9 on metals and alloys, Plastic Regulation 10/2011, CoE Resolution AP (89) 1 on the use of colorants

EN 602 = Fulfilling the EU Food Contact Standard EN 602 on aluminium and aluminium alloys

EP = Fulfilling the European Pharmacopeia monographs as applicable: 3.1.3 (Polyolefins), 3.1.5 (Polyethylene with additives for containers for parenteral preparations and for ophthalmic preparations), 3.1.6 (Polypropylene for containers and closures for parenteral and ophthalmic preparations), 3.2.2 (Plastic containers and closures for pharmaceutical use)

EU CR = Considering the EU Cosmetic Regulation (EU) No 1223/2009 and communicating required information as defined in the Advisory Document of the Cosmetics Europe association

DoC = Fulfilling the legal obligations of primary food packaging producers by providing a Declaration of Compliance (DoC) within the meaning of Article 16(1) of the Framework Regulation 1935/2004.